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The efficacy of therapist-supported acceptance and commitment therapy-based bibliotherapy for psychological distress after stroke: a single-case multiple-baseline study

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Background: Psychological distress is common after stroke, and affects recovery. However, there are few evidence-based psychological treatments. This study evaluates a bibliotherapy-based approach to its amelioration. Aims: To investigate a stroke-specific self-management book, based on acceptance and commitment therapy (ACT), as a therapist-supported intervention for psychological distress after stroke. Method: The design was a single case, randomised non-concurrent multiple-baseline design (MBD). Sixteen stroke survivors, eight males and eight females (mean age 60.6 years), participated in an MBD with three phases: A (randomised-duration baseline); B (intervention); and follow-up (at 3 weeks). During the baseline, participants received therapist contact only. In the bibliotherapy intervention, participants received bi-weekly therapist support. The primary measures of psychological distress (General Health Questionaire-12; GHQ-12) and quality of life (Satisfaction with Life Scale; SWLS) were completed weekly. Secondary measures of mood, wellbeing and illness impact were completed pre- and post-intervention. Results: Omnibus whole-group TAU-U analysis was statistically significant for each primary measure with a moderate effect size on both (0.6 and 0.3 for GHQ-12 and SWLS, respectively). Individual TAU-U analyses demonstrated that the majority of individuals exhibited positive change. All the secondary measures showed significant pre-post improvements. Eighty-one per cent of participants reported the book was helpful and 81% also found the ACT-based sections helpful. Relative risk calculations showed finding the book helpful was associated with improvement in GHQ-12 and SWLS scores. Conclusions: ACT-based bibliotherapy, with therapist support, is a promising intervention for psychological difficulties after stroke.
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The efficacy of therapist-supported acceptance and
commitment therapy-based bibliotherapy for
psychological distress after stroke: a single-case
multiple-baseline study
Misbah Gladwyn-Khan and Reg Morris*
Cardiff University and Cardiff & Vale UHB, Cardiff, UK
*Corresponding author. Emails: reg.morris@Plymouth.ac.uk,MorrisR8@cardiff.ac.uk
(Received 31 December 2021; revised 11 August 2022; accepted 18 August 2022)
Abstract
Background: Psychological distress is common after stroke, and affects recovery. However, there are few
evidence-based psychological treatments. This study evaluates a bibliotherapy-based approach to its
amelioration.
Aims: To investigate a stroke-specific self-management book, based on acceptance and commitment
therapy (ACT), as a therapist-supported intervention for psychological distress after stroke.
Method: The design was a single case, randomised non-concurrent multiple-baseline design (MBD).
Sixteen stroke survivors, eight males and eight females (mean age 60.6 years), participated in an MBD
with three phases: A (randomised-duration baseline); B (intervention); and follow-up (at 3 weeks).
During the baseline, participants received therapist contact only. In the bibliotherapy intervention,
participants received bi-weekly therapist support. The primary measures of psychological distress
(General Health Questionaire-12; GHQ-12) and quality of life (Satisfaction with Life Scale; SWLS)
were completed weekly. Secondary measures of mood, wellbeing and illness impact were completed
pre- and post-intervention.
Results: Omnibus whole-group TAU-U analysis was statistically significant for each primary measure with
a moderate effect size on both (0.6 and 0.3 for GHQ-12 and SWLS, respectively). Individual TAU-U
analyses demonstrated that the majority of individuals exhibited positive change. All the secondary
measures showed significant prepost improvements. Eighty-one per cent of participants reported the
book was helpful and 81% also found the ACT-based sections helpful. Relative risk calculations
showed finding the book helpful was associated with improvement in GHQ-12 and SWLS scores.
Conclusions: ACT-based bibliotherapy, with therapist support, is a promising intervention for
psychological difficulties after stroke.
Keywords: acceptance and commitment therapy; bibliotherapy; self-management; stroke
Introduction
Stroke is accompanied by anxiety in about 25% of people (Campbell Burton et al., 2013) and by
depression in 29% (Ayerbe et al., 2013). Psychological distress is associated with impeded
rehabilitation (Ahn et al., 2015), impaired functional outcomes (Ayerbe et al., 2014; Chun
et al., 2018a; Chun et al., 2018b), restricted activities of daily living (Tsuchiya et al., 2016) and
increased mortality (Bartoli et al., 2013). Length of hospital stays (Sugawara et al., 2015) and
© The Author(s), 2022. Published by Cambridge University Press on behalf of British Association for Behavioural and Cognitive
Psychotherapies. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://
creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is
properly cited.
Behavioural and Cognitive Psychotherapy, 2022, page 1 of 18
doi:10.1017/S135246582200042X
https://doi.org/10.1017/S135246582200042X Published online by Cambridge University Press
healthcare costs (Naylor et al., 2012) are also greater in the presence of challenges such as impaired
cognition, affective disorders, fatigue and disability that are associated with psychological distress.
Cognitive impairment occurs commonly after stroke (Nys et al., 2007); about 15% of stroke
survivors had cognitive test scores indicative of impaired activities of daily life and the need
for supported living arrangements (Liman et al., 2012). Fatigue is often another barrier to
readjustment after stroke (Acciarresi et al., 2014).
Despite the importance of addressing psychological factors after stroke, several reviews (Allida
et al., 2020; Campbell Burton et al., 2011; Gillespie et al., 2015; Hackett et al., 2008;Wuet al., 2015)
identified few psychological treatment approaches with a sound evidence-base. Consequently,
national guidelines (Intercollegiate Stroke Working Party, ICSWP-UK, The Royal College of
Physicians, 2016; National Institute for Health and Care Excellence, 2013/2018) recommend
few psychological treatments specifically for stroke. For example, the ICSWP recommends
four treatments or preventative approaches for low mood: motivational interviewing based on
one randomised controlled trial (RCT), for which a subsequent pilot RCT failed to find any
benefit (Kerr et al., 2018); behaviour therapy based on one RCT; problem solving therapy
based on two RCTs. While a meta-analysis suggested benefit of cognitive behavioural therapy
(CBT) after stroke for Chinese samples (Wang et al., 2018), the authors urge caution due to
heterogeneity and low quality (61%) of the studies and lack of corroboration in two European
studies. To date, CBT has not been recommended for stroke-specific psychological disorders
in UK stroke guidance.
Cost-effective approaches to psychological disorders after stroke are urgently needed in view of
their high prevalence and impact in the context of limited resources for psychological care (The
Royal College of Physicians, 2015). Transdiagnostic therapeutic approaches such as acceptance
and commitment therapy (ACT) (Hayes, 2004) have the potential to address a wide range of
psychological and behavioural problems without requiring staff training in several diagnosis-
specific therapy protocols. ACT simplifies the treatment of emotional difficulties by targeting
shared aetiological processes underpinning multiple forms of emotional distress (Gros et al.,
2016). Kangas and MacDonald (2011) concluded their review of CBT for acquired brain
injury with a recommendation for research into ACT with this population, stimulating two
RCTs. For people with elevated psychological distress after brain injury, ACT therapy was
beneficial in the short-term compared with a befriending control condition, although other
indices of recovery did not show improvement (Whiting et al., 2020) . Sander et al.(2020)
found that ACT for people exhibiting psychological distress after traumatic brain injury
reduced psychological distress, compared with a counselling/education intervention. However,
the control intervention in this study lacked equivalence to the ACT intervention. There is
now also growing evidence for ACTs effectiveness in reducing psychological distress and
enhancing psychological wellbeing after stroke (Graham et al., 2016; Majumdar and Morris,
2019). Reviews have concluded that ACT is cost-effective, readily translates to different
settings (Ruiz, 2010) and can be delivered in low-intensity formats (Dindo et al., 2017). In
addition, stroke survivors reported that ACT helped them to adjust to the consequences of
stroke (Large et al., 2019). Consistent with its transdiagnostic foundations, ACTs focus is not
on a single psychological difficulty or symptom. Instead, it addresses broader psychological
processes encompassed as psychological flexibility. Psychological flexibility derives from a
capacity to engage positively with six core psychological processes that form the central tenets
of the ACT model (Hayes, 2004). The relevance of psychological flexibility and its constituent
processes to people with psychological distress after a stroke was succinctly summarised by
Majumdar and Morris (2019). They pointed out that the health model underpinning ACT is
conducive to the promotion of wellbeing rather than simply symptom reduction; the emphasis
on acceptance of psychological distress and getting on with lifehas application where there
are enduring disabilities following stroke; the focus on mindfulness and being in the present
encourages a person to make contact with their surroundings and with experiences beyond
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their disability and psychological distress; building self-as-context, an observing self that is
separate from the experience of psychological distress, counters negative changes in self-
identity after stroke; finally, the discovery of a persons core values to pursue value-driven
committed actionmay represent an improvement on current goal setting practice in stroke.
Another advantage of ACT is that it is readily disseminated and administered in different
formats (Assaz et al., 2018; Dindo et al., 2017). Cost-effective delivery of psychological
interventions is vital in the context of restricted healthcare funding (Luchinskaya et al., 2017).
Many of the delivery formats of existing therapies are resource intensive, requiring one-to-one
delivery, coupled with adaptation and specialised training for different conditions (Majumdar
and Morris, 2019). Cost savings can be made by group delivery, delivery by associate grade
staff working under supervision or bibliotherapy (with therapist support or alone).
Bibliotherapy has potential to be cost-effective in stroke. It was shown to be cost-effective for
behavioural disorders in children when compared with therapist-led interventions (Sampaio
et al., 2016), and a review (Latchem and Greenhalgh, 2014) concluded that self-management
is effective in neurological conditions including head injury, dementia and stroke. Several
meta-analyses including bibliotherapy have confirmed that bibliotherapy, alone or with
therapist support, is effective for psychological treatment of emotional disorders (Cuijpers
et al., 2010; Den Boer et al., 2004; Hirai and Clum, 2006).
Bibliotherapy, which is the provision of psychological therapy through books or other written
materials, may be particularly suited to the stroke population as it can be self-paced and is
accessible by people with mobility restrictions (Jacobs and Mosco, 2008). Moreover, it can be
delivered through existing public library networks (Chamberlain et al., 2008). The aim of the
present study was to investigate the efficacy of a self-management book for stroke (Rebuilding
Your Life After Stroke, Morris et al., 2017), which uses ACT as its core model. The ACT
section of the book was broadly based on material used in a study of group therapy
(Majumdar and Morris, 2019) where it demonstrated efficacy with a group of stroke
survivors. Acceptance of psychological distress is a key goal of ACT and was identified as a
high research priority by a panel of stroke survivors, caregivers and health clinicians (Pollock
et al., 2014). The ACT programme in the book aimed to increase acceptance of the effects of
stroke as a facet of psychological flexibility that promotes positive outcomes (Kashdan, 2010).
It was hypothesised that bibliotherapy, used with therapist support, would reduce psychological
distress and improve satisfaction with life. The bibliotherapy was self-administered and self-paced
and the book consists of two distinct therapy sections with eight chapters. Therefore, in order to
facilitate its effective use over the intervention period, this study used a small-Nreplicated single-
case, non-concurrent multiple baseline design (MBD) (Watson and Workman, 1981) with
therapist support, in preference to a group-based RCT. The primary outcome measures were
brief measures chosen to assess changes in distress and satisfaction with life over the course of
the bibliotherapy, while the secondary outcome measures provided a more detailed assessment
of change in common psychological problems after stroke, as well as wellbeing and the impact
of stroke.
Method
Design and analysis
The study employed a small-Nsingle-case non-concurrent MBD. The design was non-concurrent
to improve feasibility (Watson and Workman, 1981). In this design, control for threats to internal
validity are ameliorated through (1) a baseline phase of random duration and (2) frequent
measurement throughout the baseline and intervention phases. Randomisation was achieved
by randomising baseline duration and the start of the intervention. This staggered the
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intervention across participants and permitted randomised controlled comparisons. To improve
sensitivity to change, outcomes were measured frequently at short time intervals.
Participants all started with a randomised, pre-determined length, baseline phase (see
Supplementary material 1for details) so that entry into the intervention stage was staggered,
and randomised, which allows quasi-control for time and maturation effects (Rhoda et al.,
2011). Staggering the baseline involved some participants remaining in the baseline phase
when intervention for others began. This process permits interpretation through controlling
for whole-sample confounding factors, e.g. alteration in general care practice in stroke and
current events. Primary measures were taken weekly and secondary measures at the start and
end of each phase. The statistical analysis method was designed specifically for MBDs and
partialled out baseline effects from the intervention results (www.singlecase.org; calculators)
(Vannest et al., 2016).
Sample size and phases
The MBD included 32 phases (16 participants, each with a baseline and intervention) and weekly
observations. All the baseline and intervention phases had at least three observations due to
practical issues with starting the intervention for some participants. Initially minimum
baseline points had been set at 2 weeks following advice received by the ethical committee
which advised that the feasibility of the study could be compromised through long baselines
and the likelihood of drop-out due to the complex nature of the participant population (see
Supplementary material 1). The interventions were self-paced and ranged from 3 to 16 weeks.
Based on a quality recommendation for concurrent MBDs where overlap between phases is
a part of the design (Kratochwill et al., 2013)the planned design exceeded the quality
standard for the number of phases (6) and met the quality standard for data points per phase
for 11 of the 16 baseline phases and 14 of 16 intervention phases. All the remaining phases
(7) met the quality standard with reservations.
Recruitment
As the problems of simultaneous recruitment in multiple baseline design are well documented
(Graham et al., 2012), this study recruited participants at point of referral into the study. In
line with guidelines that community interventions should be provided irrespective of time
since stroke (The Royal College of Physicians, 2016), time since stroke was not used as an
exclusion criterion.
Recruitment was from three Health Boards in Wales and one Health Trust in southwest
England, and two stroke charities. Leaflets providing brief information about the study were
provided to staff and passed on to clients. Signed informed consent was obtained by the
researcher. No financial/reward incentives were used.
Inclusion and exclusion criteria were assessed by interview by the first author.
Inclusion:
a clinical diagnosis of at least one stroke;
18 years of age or above;
reporting psychological distress to a referring clinician/key worker;
ability to read a book.
Exclusion:
diagnosis of serious psychiatric problems such as psychosis;
diagnosis of a progressive, degenerative disorder;
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serious communicative difficulties, such as aphasia;
traumatic brain injury.
Further details of recruitment and attrition can be found in Supplementary material 2.
Materials
The self-management book, Rebuilding Your Life After Stroke(Morris et al., 2017) is available
free of charge in the UK through the Reading Agency, Books on PrescriptionScheme (https://
reading-well.org.uk/books/books-on-prescription). The book was written by stroke clinicians and
stroke survivors to address common post-stroke psychological difficulties. The book is divided
into four parts: Part 1, Introduction to the book, its scope, navigation and materials; Part 2,
What is happening to me?, about common psychological distress after stroke; Part 3,
Rebuilding your life after stroke, the ACT-based content; Part 4, Summary, a synthesis and
ideas for the future. There are also lists of stroke-related resources at the end. The book is
designed with spiral binding so it can be read one-handed (see Supplementary material 3for
the Contents page of the book.)
The book provides practical guidance for the management of common psychological and
behavioural problems after stroke in Part 2 and takes ACT as the core model for approaching
more intractable forms of psychological distress in Part 3. The book has linked audio-visual
files on YouTube for practising ACT-based exercises and of interviews with stroke survivors.
Measures
Socio-demographical information
Information was collected about age, gender, date of first and most recent stroke, type of stroke,
and current psychiatric/psychological treatments.
Primary measures
As the primary measures were self-assessment measures, the standard of inter-observer agreement
for MBDs (Kratochwill et al., 2013) was not applicable. Reliability of the measures is instead
attested by the demonstration of testretest reliability in the validation of the instruments.
The primary measures were collected weekly and were chosen to cover both distress and life
satisfaction.
General Health Questionnaire-12 (GHQ-12). The GHQ-12 is a brief assessment of psychological
difficulties in the general population (Goldberg and Williams, 1988) with scores ranging from
0 to 36. The validity and reliability of the GHQ-12 have been evaluated (Hankins, 2008). In
the general population, Cronbachs alpha was 0.94 (Lesage et al., 2011). In stroke, the validity
of the General health Questionnaire (GHQ-28, which includes the GHQ-12 questions) has
been reviewed with the conclusion that it has validity as a screening instrument (Burton and
Tyson, 2015). For the GHQ-12, Hilari et al.(2003) reported a correlation of .58 with a stroke
Aphasia Quality of Life Scale. It has been shown to be acceptable as a measure of distress in
over 10 studies of stroke and was recommended as a screening measure for depression after
stroke (Bennett and Lincoln, 2006).
Satisfaction with Life Scale (SWLS). The SWLS (Diener et al., 1985) is a brief, global life-satisfaction
instrument including five questions about level of satisfaction with current life conditions.
Responses are on a 7-point scale from strongly disagree to strongly agree, and the scores
range from 5 to 35. A review of the SWLS (Pavot and Diener, 1993) cited high internal
consistency (alpha .87) and 2-month testretest reliability of .82. Construct validity has been
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demonstrated through negative correlations with tests of clinical conditions such as depression
and anxiety and positive correlations with measures of positive affect. A meta-analytic
reliability-generalisation study estimated an average Cronbachs alpha of 0.78 across 60 studies
(Vassar, 2008). Internal constancy remained high in a neurological sample with Parkinsons
disease (alpha .92) and Rasch analysis supported its validity (Loveride and Hagell, 2016).
There are currently no stroke validation studies of the SWLS. However, it has been used
successfully with stroke survivors in several studies (e.g. Mahmoud et al., 2016).
Secondary measures
Secondary measures were collected only pre- and post-intervention.
Beck Depression Inventory II (BDI-II) Fast-Screen. The BDI-II-FS (Beck et al., 1996) is a 7-item,
self-report measure. Although less thoroughly validated than the longer form of the BDI-II,
the fast-screen version avoids confounding somatic symptoms in physical illnesses (Salter
et al., 2008). The validity of the BDI-II-FS has been established in a review of studies of
mixed medical patients (Wang and Gorenstein, 2013) and it has acceptable sensitivity (0.71),
specificity (0.74) and internal consistency (0.75) in stroke (Healy et al., 2008).
Hospital Anxiety and Depression Screen (HADS). The HADS (Zigmond and Snaith, 1983)isa
14-item mood and anxiety screening tool for patients with physical illnesses. It was included
to allow comparison with other studies due to its widespread use in stroke research. The
HADS has undergone validation for use in stroke and has shown good performance:
AUC=85.9% (Prisnie et al., 2016). Sensitivity and specificity values of 0.92 and 0.65,
respectively, are established in stroke (Burton and Tyson, 2015). Cronbachs alpha has been
shown to be high at 0.85 in stroke survivors (Aben et al., 2002). Total HADS scores were
used for analyses in this study.
The Beck Anxiety Inventory (BAI). The BAI (Beck and Steer, 1993) is a 21-item self-report measure
of symptoms of anxiety. The BAI has been shown to measure general anxiety (Muntingh et al.,
2011). A comprehensive meta-analysis of 192 studies found the BAI to demonstrate sound
psychometric properties, with good reliability (Cronbachs alpha) and testretest reliability
(0.91 and 0.65, respectively). Sensitivity was .83 and specificity 0.89 in a sample of cancer
patients (Bardoshi et al., 2016). There are currently no formal validation studies of the BAI in
stroke, although one small-sample study compared it with a clinical interview, finding it had
good sensitivity but low specificity (Schramke et al., 1998). The BAI has been also been
compared with other indices of anxiety; a study evaluating anxiety in stroke survivors using
the BAI found that the rates of anxiety correlated with published rates and somatic symptoms
were not over-reported in comparison with emotional items (Barker-Collo, 2007).
The Warwick Edinburgh Mental Wellbeing Scale (WEMWS). Wellbeing was assessed separately to
psychological distress (depression and anxiety) as the absence of distress does not necessarily
signify the presence of wellbeing. The WEMWS has 14 items and its validity in non-clinical
populations was evidenced by a negative correlation with the GHQ-12 and high positive
correlations with a range of life-satisfaction scales. It had good internal consistency and test
retest reliability (0.89 and 0.83, respectively) (Stewart-Brown et al., 2011; Tennant et al., 2007).
The WEMWS has not been validated for stroke populations but has been shown to be
acceptable and accessible by stroke survivors (Majumdar and Morris, 2019).
Stroke Impact Scale (SIS). The SIS is a complete assessment of physical and functional disability
associated with stroke (Duncan et al., 2003). It is an 8-domain measure, consisting of 59 questions.
The SIS gives a composite disability score and the internal consistency of the measure ranges from
0.86 to 0.95 (Jenkinson et al., 2013). Its reliability (internal consistency and testretest) and
validity against a wide range of cognitive and performance measures have been extensively
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studied and this research is reported at: https://strokengine.ca/en/assessments/stroke-impact-
scale-sis/
Survey. Participants completed a brief, closed-question survey at the completion of the study. The
survey consisted of three enquiries using a Likert Scale of 0 to 10 (where 10 is rated as most
helpful): How helpful was the book?;Which part of the book was found to be particularly
helpful?;What aspect of wellbeing did the book help address?. Five options were provided for
each area: [Improvements to] anxiety, depression, confidence, self-activation or other.
Study procedure
Participants started baselines as they were recruited over a 10-month period in 201819. Baseline
lengths were randomised in advance using a randomisation programme. Planned randomised
baseline lengths ranged from 2 to 8 weeks.
The study consisted of three phases: baseline, intervention, and a 3-week follow-up.
The two primary measures were collected weekly and the five secondary measures were
collected before and after the intervention phase. The survey was completed at the end of the
intervention.
In the baseline phase one-to-one therapist contact occurred every 2 weeks in the patients home
to control for this element in the intervention phase. During the no active intervention, baseline
phase, therapist support consisted of person-centred support, e.g. empathy, positive regard and
congruence (Fazio et al., 2018). The sessions lasted 4050 minutes. The number of therapist
sessions received by each participant are given in Supplementary material 1.
Individuals continued with any usual treatments, e.g. anti-depressants, GP appointments,
stroke clinic appointments, specialist nurse visits, physiotherapy, etc. None was having
concurrent psychological therapy. The baseline phase allowed assessment of the effects of
these treatments as well as the therapist contact. Some participants were unable to start the
intervention at the end of the planned baseline stage and the baseline was extended until they
could do so (see Supplementary material 1for details).
During the intervention phase, each stroke survivor was given the book and therapist provided
support to use the book and to practise/apply its principles. The therapist was a pre-registration
trainee clinical psychologist with 7 years of NHS experience as a graduate psychologist and basic
(non-accredited) training in a range of therapies including ACT, CBT and general counselling.
The support was provided on an individual basis every 2 weeks by home visits and was based
on the clients expressed questions and needs in relation to their use of the book. These
sessions also lasted 4050 minutes. The number of sessions received by each participant is
given in the tabulation of the study phases in Supplementary material 1. The pace of reading/
applying the book material was decided in collaboration with the individuals. The intervention
phase length therefore varied for individual participants (between 6 and 16 weeks). The book
material used was also tailored to individuals. Session structure was as follows:
(1) Set the agenda; ask about current difficulties for which book could be used.
(2) Discuss what the book offers to manage difficulty.
(3) Review psychoeducation from the book by collaboratively considering information in the
book that is potentially helpful in promoting psychological flexibility.
(4) Try out exercises (optional) from the book.
(5) Review session and set homework from the book.
The follow-up used the primary measures (GHQ-12, SWLS). Follow-up was conducted by the
researcher 3 weeks following the completion of the final, intervention phase.
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All therapist contact and measurements took place face-to-face in the participantsplaces of
residence (apart from two contacts to the participants home by telephone). Home visits
improved recruitment and reduced the burden of travel due to stroke-related mobility
restrictions. Blinding of researcher to the phase for collection of participant self-assessments
and to the intervention was not feasible.
Statistical analysis
Analysis of the MBD was completed using TAU-U. TAU-U is an effect size that combines the
trend from the intervention phase with non-overlap from both baseline and intervention
phases and is a reliable test in multiple-baseline design analysis (Brossart et al., 2018). TAU-U
provides conservative effect sizes (Brossart et al., 2018). The TAU-U tool used is internet-
based (singlecaseresearch.org, calculators; Vannest et al., 2016). Baseline correction was used if
baseline TAU-U exceeded 0.2 (Vannest and Ninci, 2015). This TAU-U calculator yields effect
sizes for the difference in phases (Brossart et al., 2018). Effect sizes were interpreted based on
guidelines (Vannest and Ninci, 2015): <0.20, small change; 0.200.60, moderate change; 0.60
0.80, large change.
SPSS 25 was used to analyse before and after change in the secondary measures. Paired t-tests,
with Bonferroni corrections, were used to evaluate change in the scores of the secondary measures
between the pre- and post-intervention assessment points. A sample of 13 is required to detect a
large effect size (Dz) with a power of 0.9 with a one-tailed test.
Survey analysis
Relative risk can be used to determine associations in cohort studies (Viera, 2008). Here it was
defined as the rate of reported benefit if exposure to the book was found helpful (rated as >6/10)
divided by the rate of reported benefit in those who did not find the book helpful.
Results
The flow of participants from their initial recruitment to the study is depicted in the PRIMA
diagram in Supplementary material 4.
The median number of baseline and intervention weeks were 6.0 (range 311) and 11.0 (range
316), respectively. The corresponding medians for therapist contacts and therapist time during
baseline and intervention phases were 3.0 sessions (range 14) or 2.25 hours and 5.0 sessions
(range 28) or 3.75 hours, respectively (see Supplementary material 1).
Demographical analysis
Table 1gives a summary of the sample characteristics. The mean time since stroke was 19 months.
Primary measuresanalysis: GHQ-12 and SWLS
Figures S2 to S17 (see Supplementary material 5) illustrate the effects of intervention on the GHQ-
12 and SWLS. Graphs for participants 3 and 8 are given as illustrations in Fig. 1. The GHQ-12
scores were indicative of high levels of psychological distress in this sample, with 14 of 16
participants scoring 20 or over at the start of the baseline. On the SWLS only two participants
scored in the very dissatisfied range at the start of baseline, but all scored below 20, which is
regarded as the neutralpoint on the scale.
The whole-sample omnibus analysis of the GHQ-12 results was statistically significant with a
moderate effect size (0.6, p<0.05). TAU-U scores were computed for each participant; all
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demonstrated an effect in the positive direction and seven (43.7%) showed statistically significant
effects. Due to the short baselines of some participants the absence of more individual significant
effects was not unexpected.
The whole-sample omnibus analysis of the SWLS results was also statistically significant
(TAU=0.3; p<0.05) with a moderate effect size. Individual TAU-U analyses showed a positive
effect of the intervention for 12 (75.0%) of the participants and five (31.3%) were statistically
significant. However, two participants showed statistically significant effects in a negative
direction on this measure. See Table 2.
Follow-up
Paired sample t-tests for the 3-week follow-up results of both primary measures compared final
intervention scores and 3-week follow-up scores on GHQ-12 [means 9.0 (5.1) and 10.7 (6.5),
respectively] and SWLS [(means 17.1 (9.2) and 18.8 (8.5), respectively]. Differences were not
statistically significant. This was commensurate with the maintenance of gains.
Secondary measures analysis
Paired samples, t-test, results of the prepost, whole-group analysis of the BDI, BAI, HADS,
WEMWS and SIS are presented in Table 3. At baseline, mean BDI-II scores were in the
Table 1. Sample characteristics
Participant
Age and
gender Type of stroke
Number of
strokes
Employment status (R: retired, W:
working, U: unemployed) Medication
1 53, F Infarct, lateralisa-
tion unknown
1 U Sertraline
2 59, M Right-sided hae-
morrhage
1Un/a
3 52, M Right-sided
ischaemic
attack
1 U Citalopram
4 84, F Left-sided infarct 1 R NA
5 56, M Left haemorrhage
and TIA
2 U Beta-blockers
6 73, F Right-sided infarct 1 U Carbamazepine
and Lorazepam
7 29, F Left-sided hae-
morrhage
1 U Propanol
8 80, M Cerebellar infarct
and TIA
2 R Sertraline
9 67, M Left-sided Infarct
and TIA
2 R Citalopram
10 82, M Mid-brain infarct
and TIA
2Rn/a
11 56, F Left-sided infarct
and TIA
2 U Citalopram
12 56, M Left-sided infarct 1 W n/a
13 56, F Left-sided infarct
and TIA
2 U Sertraline
14 53, M Right-sided infarct 2 U Sertraline and
Diazepam
15 34, F Left-sided hae-
morrhage
1Wn/a
16 79, F Left-sided infarct 1 R Amitriptyline
Behavioural and Cognitive Psychotherapy 9
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normal range, while BAI and HADS total scores indicated significant distress. Following
Bonferroni correction (adjusted α=0.01), the results of the prepost, whole-group analysis
remained statistically significant.
Figure 1. Baseline and intervention scores for GHQ and SW for participants 3 and 8. GHQBn, GHQ-12 baseline; GHQIn,
GHQ-12 intervention; SWBIn, SWLS baseline; SWIn, SWLS intervention; nis the number of the participant.
10 Misbah Gladwyn-Khan and Reg Morris
https://doi.org/10.1017/S135246582200042X Published online by Cambridge University Press
Survey results
Survey results are presented in Table 4. Eighty-one per cent of the sample reported the book was
very helpful. It was reported useful for anxiety, low mood, confidence, motivation, acceptance and
understanding carers role. Eighty-one per cent of the sample also reported Part 3, which contains
the ACT programme, as helpful.
The relative risk calculation showed that the chance of improvement on the GHQ-12 if the
book was found helpful was 81% and the corresponding figure of the SWLS was 68%. The
chance of improvement on GHQ-12 if the book was found helpful was increased by a factor
of 8, compared with if the book was not found helpful. The corresponding factor for the
SWLS approached 7.
Discussion
The TAU-U whole-sample omnibus results for both primary measures showed moderate effect
sizes of the intervention on both GHQ-12 and the SWLS over a median of 11 weeks of using the
book with six therapist contacts (median 4.5 hours in total). Individual analyses support the
omnibus analysis with the majority of participants showing changes in a positive direction on
both measures. This lends support to the hypothesis that ACT-based bibliotherapy, with
therapist support, was beneficial for the psychological wellbeing and quality of life of stroke
survivors in the short term. The outcome extends the conclusion of meta-analyses of
Table 2. Individual TAU-U statistics for GHQ-12 and SWLS
Participant no.
GHQ-12 SWLS
TAU-U Effect size p-value TAU-U Effect size p-value
1 0.50 Moderate 0.110 0.70 Large 0.021*
2 0.90 Large 0.000* 0.40 Moderate 0.011*
3 0.10 Small 0.717 0.69** Moderate 0.016*
4 0.71 Moderate 0.011* 0.58 Moderate 0.038*
5 0.70 Large 0.018* 0.66 Moderate 0.027*
6 0.42 Moderate 0.212 0.42 Moderate 0.183
7 0.70 Large 0.031* 0.28 Small 0.395
8 0.98 Large 0.000 * 0.80 Large 0.004*
9 0.50 Moderate 0.121 0.60 Moderate 0.071
10 0.60 Moderate 0.027* 0.30 Moderate 0.239
11 0.10 Very small 0.730 0.43 Moderate 0.174
12 0.07 Very small 0.813 0.16** Small 0.592
13 0.60 Moderate 0.155 0.60 Large 0.110
14 0.22 Small 0.662 0.33 Moderate 0.512
15 0.14 Small 0.608 0.94** Large 0.007
16 0.83 Large 0.000* 0.50** Moderate 0.143
*alpha<0.05; **indicates reduced satisfaction with life.
Table 3. Whole-sample prepost analysis for secondary measures
Measure
Pre-test
mean (SD)
Post-test
mean (SD) Paired t-test
BDI-II 8.4 (4.7) 4.3 (4.2) p<.001
BAI 22.6 (11.4) 9.9 (10.5) p<.0001
HADS 23.1 (8.9) 14.7 (8.6) p<.0001
WEMWS 36.9 (11.5) 48.9 (11.7) p<.0001
SIS 188.9 (36.0) 218.3 (30.2) p<.001
BDI-II, Beck Depression Inventory-II; BAI, Beck Anxiety Inventory; HADS, Hospital Anxiety and Depression Scale; WEMWS, Warwick Edinburgh
Mental Wellbeing Scale; SIS, Stroke Impact Scale.
Behavioural and Cognitive Psychotherapy 11
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bibliotherapy in the mental health context (Cuijpers et al., 2010; Den Boer et al., 2004; Hirai and
Clum, 2006) to psychological sequelae of a physical health condition. It also supports the
conclusions of Majumdar and Morris (2019) that ACT-based interventions are beneficial for
stroke survivors, at least in the short term. This outcome was achieved with a medium of only
4.5 hours of therapist contact in the intervention phase and is encouraging for the
development of cost-effective, low-intensity interventions for psychological distress (Latchem
and Greenhalgh, 2014; Sampaio et al., 2016), delivered through book prescription schemes
(Chamberlain et al., 2008).
All secondary outcome measures showed large statistically significant change in a positive
direction. Although these prepost results may be a consequence of temporal change
unconnected to the intervention, they are congruent with those of the controlled MBD and
together these findings support the efficacy of bibliotherapy.
In this study, the WEMWS wellbeing scale and the SWLS quality of life measure both showed
significant change over time, whereas Majumdar and Morris (2019) found they did not show
benefit in a controlled trial of group-based ACT. They attributed the lack of benefit to
insufficient intervention time (4 weeks) to develop secondary benefits in overall wellbeing.
The longer study period here may have allowed sufficient time for this. The improvement on
the SWLS may also reflect the individualised approach of the current study in contrast to the
group-based didactic approach taken by Majumdar and Morris (2019), as the stroke survivors
were able to discuss and plan individual values-based activities and social engagement during
the therapist support sessions. Generally, in the absence of psychological intervention, post-
stroke life satisfaction remains low despite extensive rehabilitation (Langhammer et al., 2017).
Improving quality of life is a priority in view of the high prevalence of post-stroke disability
(Carmo et al., 2015) and the bibliotherapy approach is promising in this respect.
The Stroke Impact Scale (SIS) showed positive change in perceptions and experiences of
disability after stroke and includes dimensions of Health Related Quality of Life (Salter et al.,
2008). This finding may attest to the role of acceptance and defusion (Graham et al., 2016)in
amelioration of negative psychological processes stemming from enduring disability and loss
of function which are frequent consequences of stroke (American Heart Association, 2011;
Table 4. Survey results
Participant
Helpfulness rating
010
(10 =extremely
helpful) What did the book help with?
Which part of the book was
most helpful?
1 5 Anxiety: understanding burden on carer2
2 8 Confidence and low mood 1, 2, 3
3 8 Confidence: learning that I can get through it2
4 10 Confidence 3
5 8 Anxiety 3
6 10 Confidence 3
7 10 Anxiety, low mood 2, 3
8 10 Anxiety, low mood 3
9 9 Getting motivated 3
10 10 Low mood, confidence, anxiety 3
11 7 Anxiety thoughts 3
12 9 Anxiety, motivation 3
13 Lost to follow-up* ——
14 10 Anxiety, confidence 2, 3
15 10 Low mood, confidence, anxiety 3
16 7 Confidence: understanding and realising you
are not alone
1, 2, 3
*Participants view of the book prior to drop-out was favourable: I carry it around with me
reason given for otherresponse.
12 Misbah Gladwyn-Khan and Reg Morris
https://doi.org/10.1017/S135246582200042X Published online by Cambridge University Press
Feigin et al., 2017). ACTs focus on identifying values to underpin goal setting and value-based
living may be particularly helpful in promoting active engagement in the context of enduring
disabilities (Clarke et al., 2014). Value-based living is associated with psychological wellbeing
and improved function in people after traumatic brain injury (Pais et al., 2019).
Taken together, the results of the SWLS, WEMWS and SIS tentatively support the
bibliotherapy-ACT intervention as an effective intervention for enhanced wellbeing and
quality of life for stroke survivors.
The brief survey showed that the book was perceived favourably by participants, with 81% of
the sample reporting part 3 (ACT intervention) as the most helpful part. ACT fits particularly well
in stroke from a theoretical and practical point of view. Its therapeutic techniques do not aim
primarily to alleviate psychological distress (Guadiano, 2011) but rather to enhance
psychological flexibility to change the relationship between a person, their distress and the
behaviours the distress engenders. This promotes the transdiagnostic nature of ACT by
requiring less specificity for interventions than psychological approaches based on cognitive
processes and reinforcement contingencies (Assaz et al., 2018).
The emphasis of ACT on experiential learning enables it to be used successfully with
generalised cognitive impairments in learning disability settings (Brown and Hooper, 2009).
For example, the ACT process of defusion (distinguishing between thoughts and reality) does
not require cognitive reframing of psychologically distressing thoughts in order to reduce
negative responses to thoughts (Assaz et al., 2018) and has been shown to produce more
rapid change than cognitive restructuring (Deacon et al., 2011). Cognitive factors may also
underpin ACTs success with complex presentations, i.e. treatment-resistant populations
(Clarke et al., 2014).
Limitations and future research
This MBD study provided a level of experimental control but a concurrent design, where all the
participants start baseline at the same time, would have provided more definitive evidence.
Further research using randomised control conditions, blinding to hypotheses and phases/
conditions, longer baselines and follow-up and larger samples is required to address the
limitations of this study and strengthen evidence for the effectiveness of ACT-based supported
bibliotherapy in stroke. Although all baselines were 3 weeks or longer, it would have added
greater control to ensure planned randomised baseline lengths were set at a minimum of 3
weeks. However, the minimum of 2 weeks was dictated by ethical concerns about attrition
during a non-treatment period for this fragile population. In addition, inclusion of only those
with clinical levels of psychological distress would enhance generalisability to clinical
populations. However, data from the current study may be valuable in establishing aspects of
feasibility of future randomised studies as well as the length of intervention required.
Investigations of bibliotherapy without therapist support are also required to determine if
efficacy is maintained in its absence as this could limit the cost-effectiveness of the approach.
Although three of the measures used had not been fully validated in stroke, all had previously
been used successfully with this population. People with severe aphasia and who could not
read were not included in the study and research using communication aids for this sample
would extend the findings. The current study did not include a measure of ACT processes
related to psychological flexibility as, when the study was designed, none was validated
specifically for stroke or had been demonstrated to be acceptable for this population.
Inclusion of validated ACT-process measures would increase confidence that ACT-specific
factors are responsible for benefits. While the baselines were randomised in advance of the
study, it was not possible for all participants to transfer to the intervention in the identified
week due to unplanned events such as individual or family illness. In these cases, the baseline
and data collection were continued (median 1 week) until the participant could start the
Behavioural and Cognitive Psychotherapy 13
https://doi.org/10.1017/S135246582200042X Published online by Cambridge University Press
intervention. It was considered that such unplanned extensions would not affect the conclusions
as extended baseline phases allow rigorous comparisons.
Service implications
Co-morbidity of stroke and mood-based difficulties is high (Hackett and Pickles, 2014).
Healthcare cost is increased by psychological co-morbidity in long-term conditions (Naylor
et al., 2012). The Royal College of Physicians (2016) suggest that stroke patients should be
offered a choice of interventions for psychological difficulties. The results of the current study
indicate that the novel ACT-based bibliotherapy, with therapist support, is effective in the
short term. The intervention can be tailored to individual needs and requires less therapist
time per week than traditional therapy.
Supplementary material. To view supplementary material for this article, please visit: https://doi.org/10.1017/
S135246582200042X
Data availability statement. The data are available from the first author (TAU-U analyses and relative risk analysis) and the
second author (all other analyses) upon reasonable request.
Acknowledgements. The authors would like to acknowledge the generous assistance received in recruiting participants from
Bristol After Strokecharity, The Stroke Association (Wales) and Dr Irina Lapadatu, clinical psychologist, Bristol.
Author contributions. Misbah Gladwyn-Khan: Data curation (equal), Formal analysis (equal), Investigation (lead),
Methodology (equal), Project administration (lead), Software (lead), Visualization (lead), Writing original draft (lead),
Writing review & editing (supporting); Reg Morris: Conceptualization (lead), Data curation (equal), Formal analysis
(equal), Investigation (supporting), Methodology (equal), Supervision (lead), Writing original draft (supporting),
Writing review & editing (lead).
Financial support. The study was funded by salary support for the first author from Health Education and Improvement
Wales. The work formed part of a DClinPsy programme.
Conflicts of interest. R. Morris is an author of the book that is the subject of this evaluation. However, royalties from sales of
the book are paid to NHS Wales.
Ethical standards. This study abided by the ethical principles of the BPS and BABCP. This study was approved through the
integrated research applications system (IRAS) for NHS ethics, IRAS ID 232266. Research and Development Department
permission was granted by four Health Boards/Trusts (three in south Wales, one in south-west England). Three stroke
survivors were consulted during the design of the study. They suggested that individual support from a therapist should
be included.
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Cite this article: Gladwyn-Khan M and Morris R. The efficacy of therapist-supported acceptance and commitment therapy-
based bibliotherapy for psychological distress after stroke: a single-case multiple-baseline study. Behavioural and Cognitive
Psychotherapy.https://doi.org/10.1017/S135246582200042X
18 Misbah Gladwyn-Khan and Reg Morris
https://doi.org/10.1017/S135246582200042X Published online by Cambridge University Press
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Background: Depression is an important morbidity associated with stroke that impacts on recovery yet often undetected or inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and updated in 2008. Objectives: Primary objective • To determine whether pharmacological therapy, non-invasive brain stimulation, psychological therapy, or combinations of these interventions reduce the prevalence of diagnosable depression after stroke Secondary objectives • To determine whether pharmacological therapy, non-invasive brain stimulation, psychological therapy, or combinations of these interventions reduce levels of depressive symptoms, improve physical and neurological function and health-related quality of life, and reduce dependency after stroke • To assess the safety of and adherence to such treatments SEARCH METHODS: We searched the Specialised Registers of Cochrane Stroke and Cochrane Depression Anxiety and Neurosis (last searched August 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), in the Cochrane Library, MEDLINE (1966 to August 2018), Embase (1980 to August 2018), the Cumulative Index to Nursing and Alllied Health Literature (CINAHL) (1982 to August 2018), PsycINFO (1967 to August 2018), and Web of Science (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) to August 2018; ClinicalTrials.gov to August 2018), and conference proceedings, and we contacted study authors. Selection criteria: Randomised controlled trials comparing (1) pharmacological interventions with placebo; (2) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; (3) one of various forms of psychological therapy with usual care and/or attention control; (4) pharmacological intervention and various forms of psychological therapy with pharmacological intervention and usual care and/or attention control; (5) non-invasive brain stimulation and pharmacological intervention with pharmacological intervention and sham stimulation or usual care; (6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and (9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of treating depression after stroke. Data collection and analysis: Two review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I² statistic and certainty of the evidence according to GRADE. Main results: We included 49 trials (56 comparisons) with 3342 participants. Data were available for: (1) pharmacological interventions with placebo (with 20 pharmacological comparisons); (2) one of various forms of non-invasive brain stimulation with sham stimulation or usual care (with eight non-invasive brain stimulation comparisons); (3) one of various forms of psychological therapy with usual care and/or attention control (with 16 psychological therapy comparisons); (4) pharmacological intervention and various forms of psychological therapy with pharmacological intervention and usual care and/or attention control (with two comparisons); and (5) non-invasive brain stimulation and pharmacological intervention with pharmacological intervention and sham stimulation or usual care (with 10 comparisons). We found no trials for the following comparisons: (6) pharmacological intervention and various forms of psychological therapy interventions versus placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation versus placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and (9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy. Treatment effects observed: very low-certainty evidence from eight trials suggests that pharmacological interventions decreased the number of people meeting study criteria for depression (RR 0.70, 95% CI 0.55 to 0.88; 1025 participants) at end of treatment, and very low-certainty evidence from six trials suggests that pharmacological interventions decreased the number of people with less than 50% reduction in depression scale scores at end of treatment (RR 0.47, 95% CI 0.32 to 0.69; 511 participants) compared to placebo. No trials of non-invasive brain stimulation reported on meeting study criteria for depression at end of treatment. Only one trial of non-invasive brain stimulation reported on the outcome <50% reduction in depression scale scores; thus, we were unable to perform a meta-analysis for this outcome. Very low-certainty evidence from six trials suggests that psychological therapy decreased the number of people meeting the study criteria for depression at end of treatment (RR 0.77, 95% CI 0.62 to 0.95; 521 participants) compared to usual care/attention control. No trials of combination therapies reported on the number of people meeting the study criteria for depression at end of treatment. Only one trial of combination (non-invasive brain stimulation and pharmacological intervention) therapy reported <50% reduction in depression scale scores at end of treatment. Thus, we were unable to perform a meta-analysis for this outcome. Five trials reported adverse events related to the central nervous system (CNS) and noted significant harm in the pharmacological interventions group (RR 1.55, 95% CI 1.12 to 2.15; 488 participants; very low-certainty evidence). Four trials found significant gastrointestinal adverse events in the pharmacological interventions group (RR 1.62, 95% CI 1.19 to 2.19; 473 participants; very low-certainty evidence) compared to the placebo group. No significant deaths or adverse events were found in the psychological therapy group compared to the usual care/attention control group. Non-invasive brain stimulation interventions and combination therapies resulted in no deaths. Authors' conclusions: Very low-certainty evidence suggests that pharmacological or psychological therapies can reduce the prevalence of depression. This very low-certainty evidence suggests that pharmacological therapy, psychological therapy, non-invasive brain stimulation, and combined interventions can reduce depressive symptoms. Pharmacological intervention was associated with adverse events related to the CNS and the gastrointestinal tract. More research is required before recommendations can be made about the routine use of such treatments.
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Copious research on the utility of Acceptance and Commitment Therapy (ACT) in long-term conditions has demonstrated promising results. However, little research has been conducted on ACT within stroke, particularly studies that are qualitative in nature. The aim of this paper was to gain insight into stroke survivors’ experiences of ACT and to explore what processes help facilitate adjustment in living with residual disability. Interviews with thirteen stroke survivors following their attendance at a stroke-adapted ACT group were analysed using a grounded theory approach. Stroke survivors varied in age, severity of stroke, limitations and duration since stroke. Interviews revealed a main difficulty of “accepting a changed reality” following stroke. Survivors’ narratives regarding their experiences of ACT revealed insight into which processes helped facilitate movement towards accepting symptoms and a changed reality and into helpful and less helpful aspects of the intervention. Stroke survivors find ACT helpful in adjusting to stroke limitations. ACT appears to have potential as a psychological intervention for stroke survivors experiencing psychological distress. Amendments to the format of the intervention to enhance the impact of ACT impact are identified.
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Tau (τ), a nonparametric rank order correlation statistic, has been applied to single-case experimental designs with promising results. Tau-U, a family of related coefficients, partitions variance associated with changes in trend and level. By examining within-phase trend and across-phase differences separately with Tau-U, single-case investigators may gain useful descriptive and inferential insights about their data. Heuristic data sets were used to explore Tau-U’s conceptual foundation, and 115 published single-case data sets were analyzed to demonstrate that Tau-U coefficients perform predictably when they are well understood. An understanding of Tau-U’s theoretical basis and unique limitations will help investigators select the appropriate statistical method to test their hypotheses and interpret their results appropriately. Limitations of Tau-U include as follows: vague or inconsistent Tau-U terminology in published single-case research; arithmetic problems that lead to unexpected and difficult-to-interpret results, especially when controlling for baseline trend; Tau-U methods are difficult to graph visually, and a comparison with visual raters found that several Tau-U effect size statistics are weakly correlated with visual analysis. © 2018, © 2018 The Author(s). This open access article is distributed under a Creative Commons Attribution (CC-BY) 4.0 license.
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Background Anxiety affects a quarter of strokes. It can be disabling even after mild stroke and transient ischaemic attack (TIA). It is not feasible to deliver conventional psychological therapies to the large population of anxious stroke and TIA patients. We are testing the feasibility of a web-enabled randomised controlled trial (RCT) to compare an individualised telemedicine cognitive behavioural therapy (CBT)-based intervention with a self-guided web-based relaxation programme. This study aims to evaluate the feasibility of novel trial procedures and the delivery of the TASK interventions in stroke and TIA patients. Methods We aim to recruit 40 community-based stroke and TIA patients experiencing anxiety at least 1 month post-discharge in Lothian, Scotland. We will assess the (1) recruitment number per month; (2) percentage completion of electronic consent; (3) time taken for remote eligibility confirmation; (4) percentage completion of follow-up surveys: modified Rankin scale, EuroQol-5D5L, 7-item generalised anxiety disorder, Patient Health Questionnaire-2 and modified fear questionnaire; (5) data capture of intervention fidelity and (6) use of actigraph smartwatches to obtain continuous data of rest/activity. Discussion The current study will provide feasibility data on streamlined web-enabled trial procedures and the use of smartwatches to obtain objective measures in stroke and TIA patients, offering potential for large efficient RCTs to be conducted centrally and remotely with far fewer resources in the future. This study will inform further refinements of the TASK interventions before evaluation in a definitive RCT. Trial registration Clinicaltrials.gov NCT03439813. Retrospectively registered on 20/2/2018. Electronic supplementary material The online version of this article (10.1186/s40814-018-0329-x) contains supplementary material, which is available to authorized users.
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Objectives To date, the efficacy of acceptance and commitment therapy (ACT) for stroke survivors has not been established. The aim of this study was to evaluate the efficacy of group‐based ACT for stroke survivors in comparison with treatment as usual (TAU) controls. Methods Fifty‐three participants were randomly assigned either to group‐based ACT (ACTivate Your Life after Stroke) or to a TAU control group (60% male; mean age: 63 years). The ACT intervention consisted of four weekly 2‐hr didactic group sessions. Therapeutic effects were measured by examining changes in depression (primary outcome), anxiety, hope, health‐related quality of life, self‐rated health status, and mental well‐being. Measures were completed at pre‐treatment, post‐treatment, and 2‐month follow‐up. A mixed‐design repeated‐measures multivariate ANOVA was conducted to analyse the findings. Results Analysis based on intention to treat found that compared to participants in the TAU control, group‐based ACT significantly reduced depression and increased self‐rated health status and hopefulness in stroke survivors, with medium effect sizes. Significantly more participants reached clinically significant change of depression in the ACT intervention in comparison with the control group. Conclusions The results correspond with previous studies of group‐based ACT with other long‐term conditions. The findings from this current study suggest group‐based ACT may have promising utility and could offer a suitable low‐intensity psychological intervention for stroke survivors. However, further large‐scale research is required. Practitioner points • Acceptance and commitment therapy (ACT), delivered didactically to groups of stroke survivors, proved feasible and acceptable. • ACT had benefits, relative to treatment as usual, for depression, health status, and hope. • Several secondary outcome variables did not show dependable benefit for ACT: anxiety; health‐related quality of life; and mental well‐being. • Results should be treated as preliminary as the sample size was small, blinding was not possible, concomitant treatments were not monitored, and there was no attention control condition. • Despite these limitations, group‐based ACT merits further study as a potentially effective intervention.
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Acceptance and commitment therapy (ACT) is a contextual–behavioral approach to psychotherapy and other behavioral health concerns that has progressively attracted attention from both researchers and clinicians. ACT’s psychological flexibility model relies on middle-level terms that, despite being less precise than behavioral principles, are seen as being valuable for teaching and practicing ACT. One such term is cognitive defusion, which refers to the reduction of stimulus function transformation that occurs through verbal relations. In other words, defusion aims to minimize the influence of verbal relations, such as thoughts, on behavior, when doing so leads to adaptive behavior and valued living. Recently, some authors have stressed the importance of functionally defining middle-level terms, establishing clear links between the concept and basic behavioral processes. This article begins this endeavor by analyzing these links with respect to cognitive defusion. First, we briefly contextualize ACT’s theoretical roots. Second, we present cognitive defusion as a therapeutic intervention, reviewing its objectives, procedures, outcomes, and hypothesized processes as stated in the relevant literature. Third, the outlined process of change is critically examined, leading to a new conceptualization of cognitive defusion. Finally, the conceptual, clinical, and research implications of this new conceptualization are considered.
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Psychological distress is common in persons with traumatic brain injury (TBI) but treatments remain underdeveloped. This randomized controlled trial of Acceptance and Commitment Therapy (ACT) was designed to address this gap. Ninety-three persons with medically-documented complicated mild to severe TBI, normal-to-mildly impaired memory, and clinically significant psychological distress in the chronic phase of recovery were randomized to receive eight weeks of ACT (manualized with adaptations to address TBI-related cognitive impairments) or a single session of needs assessment, brief counseling/education, and referral. The ACT group showed significantly greater reduction of psychological distress (Brief Symptom Inventory 18) and demonstrated improvements in psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores). The number of treatment responders (post-treatment BSI 18 GSI T scores <63) was larger in the ACT group than in the control group. Entry of AAQ-II scores into the model of between-group differences in BSI 18 GSI T scores indicated that core ACT processes explained the variance in treatment group outcomes. Provision of ACT reduces psychological distress in persons with TBI in the chronic phase of recovery when adaptations are made to accommodate TBI-related cognitive impairments. Additional clinical trials with a structurally equivalent control group are needed.
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This study i⁠nvestigated if an Acceptance and Commitment Therapy (ACT) intervention (ACT-Adjust) can facilitate psychological adjustment and reduce psychological distress following severe traumatic brain injury (TBI). The study design comprised a single centre, two-armed, Phase II pilot randomized controlled trial. Nineteen individuals with severe TBI (PTA ≥7 days) who met a clinical threshold for psychological distress (Depression Anxiety Stress Scales-21; DASS > 9) were randomly allocated to either ACT-Adjust (n = 10) or an active control, Befriending Therapy (n = 9), in conjunction with a holistic rehabilitation programme. Primary (psychological flexibility, rehabilitation participation) and secondary (depression, anxiety & stress) outcomes were measured at three-time points (pre, post and follow up). Significant decreases were found for DASS-depression (group by time interaction, F1,17 = 5.35, p = .03) and DASS-stress (group by time interaction, F1,17 = 5.69, p = .03) in comparison to the Befriending group, but not for the primary outcome measures. The reduction in stress post-treatment was classed as clinically significant, however interaction differences for stress and depression were not maintained at one month follow up. Preliminary investigations indicate potential for ACT in decreasing psychological distress for individuals with a severe TBI with further sessions required to maintain treatment gains. The pilot results suggest further investigation is warranted in a larger scale clinical trial.
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Background: Cognitive behavioral therapy (CBT) has been widely used for post-stroke depression (PSD), but the findings have been inconsistent. This is a meta-analysis of randomized controlled trials (RCTs) of CBT for PSD. Methods: Both English (PubMed, PsycINFO, Embase) and Chinese (WanFang Database, Chinese National Knowledge Infrastructure and SinoMed) databases were systematically searched. Weighted and standardized mean differences (WMDs/SMDs), and the risk ratio (RR) with their 95% confidence intervals (CIs) were calculated using the random effects model. Results: Altogether 23 studies with 1,972 participants with PSD were included and analyzed. Of the 23 RCTs, 39.1% (9/23) were rated as high quality studies, while 60.9% (14/23) were rated as low quality. CBT showed positive effects on PSD compared to control groups (23 arms, SMD = -0.83, 95% CI: -1.05 to -0.60, P < 0.001). Both CBT alone (7 arms, SMD = -0.76, 95% CI: -1.22 to -0.29, P = 0.001) and CBT with antidepressants (14 arms, SMD = -0.95, 95% CI: -1.20 to -0.71, P < 0.00001) significantly improved depressive symptoms in PSD. CBT had significantly higher remission (6 arms, RR = 1.76, 95% CI: 1.37-2.25, P < 0.00001) and response rates (6 arms, RR = 1.41, 95% CI: 1.22-1.63, P < 0.00001), with improvement in anxiety, neurological functional deficits and activities of daily living. CBT effects were associated with sample size, mean age, proportion of male subjects, baseline depression score, mean CBT duration, mean number of CBT sessions, treatment duration in each session and study quality. Conclusion: Although this meta-analysis found positive effects of CBT on depressive symptoms in PSD, the evidence for CBT is still inconclusive due to the limitations of the included studies. Future high-quality RCTs are needed to confirm the benefits of CBT in PSD.
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Background: Parenting programs and self-help parenting interventions employing written materials are effective in reducing child conduct problems (CP) in the short-term compared to control groups, however evidence on the cost-effectiveness of such interventions is insufficient. Few studies have looked at the differences in effects between interventions in the same study design. Aim: This study aimed to determine the cost-effectiveness of four parenting programs: Comet, Incredible Years (IY), Cope and Connect, and bibliotherapy, compared to a waitlist control (WC), with a time horizon of 4 months, targeting CP in children aged 3-12 years. Methods: This economic evaluation was conducted alongside an RCT of the four parenting interventions and bibliotherapy compared to a WC. The study sample consisted of 961 parents of 3-12 year-old children with CP. CP was measured by the Eyberg Child Behavior Inventory. Effectiveness was expressed as the proportion of "recovered" cases of CP. The time horizon of the study was four months with a limited health sector perspective, including parents' time costs. We performed an initial comparative cost analysis for interventions whose outcomes differed significantly from the WC, and later a cost-effectiveness analysis of interventions whose outcomes differed significantly from both the WC and each other. Secondary analyses were performed: (i) joint outcome "recovered and improved", (ii) intervention completers, (iii) exclusion of parents' time costs, (iv) exclusion of training costs. Results: All interventions apart from Connect significantly reduced CP compared to the WC. Of the other interventions Comet resulted in a significantly higher proportion of recovered cases compared to bibliotherapy. A comparative cost analysis of the effective interventions rendered an average cost per recovered case for bibliotherapy of USD 483, Cope USD 1972, Comet USD 3741, and IY USD 6668. Furthermore, Comet had an ICER of USD 8375 compared to bibliotherapy. Secondary analyses of "recovered and improved" and of intervention completers held Cope as the cheapest alternative. Exclusion of parents' time and training costs did not change the cost-effectiveness results. Discussion: The time horizon for this evaluation is very short. This study also had a limited costing perspective. Results may be interpreted with caution when considering decision-making about value for money. The inclusion of a multi-attribute utility instrument sensitive to domains of quality-of-life impacted by CP in children would be valuable so that pragmatic value for money estimations can be made. Implications for future research: Further studies are needed with longer follow-up periods to ascertain on the sustainability of the effects, and fuller economic evaluations and economic modeling to provide insights on longer-term cost-effectiveness. These results also raise the need to investigate the cost-effectiveness of the provision of these interventions as a "stepped care" approach. Conclusions: The results suggest the delivery of different programs according to budget constraints and the outcome desired. In the absence of a WTP threshold, bibliotherapy could be a cheap and effective option to initially target CP within a limited budget, whereas Comet could be offered to achieve greater effects based on decision-makers' willingness to make larger investments. In its turn, Cope could be offered when targeting broader outcomes, such as symptom improvement, rather than clinical caseness.