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An early Phase II randomised controlled trial testing the effect on persecutory delusions of using CBT to reduce negative cognitions about the self: The potential benefits of enhancing self confidence

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Background Research has shown that paranoia may directly build on negative ideas about the self. Feeling inferior can lead to ideas of vulnerability. The clinical prediction is that decreasing negative self cognitions will reduce paranoia. Method Thirty patients with persistent persecutory delusions were randomised to receive brief CBT in addition to standard care or to standard care (ISRCTN06118265). The six session intervention was designed to decrease negative, and increase positive, self cognitions. Assessments at baseline, 8 weeks (posttreatment) and 12 weeks were carried out by a rater blind to allocation. The primary outcomes were posttreatment scores for negative self beliefs and paranoia. Secondary outcomes were psychological well-being, positive beliefs about the self, persecutory delusions, social comparison, self-esteem, anxiety, and depression. Results Trial recruitment and retention were feasible and the intervention highly acceptable to the patients. All patients provided follow-up data. Posttreatment there was a small reduction in negative self beliefs (Cohen's d = 0.24) and a moderate reduction in paranoia (d = 0.59), but these were not statistically significant. There were statistically significant improvements in psychological well-being (d = 1.16), positive beliefs about the self (d = 1.00), negative social comparison (d = 0.88), self-esteem (d = 0.62), and depression (d = 0.68). No improvements were maintained. No adverse events were associated with the intervention. Conclusions The intervention produced short-term gains consistent with the prediction that improving cognitions about the self will reduce persecutory delusions. The improvement in psychological well-being is important in its own right. We recommend that the different elements of the intervention are tested separately and that the treatment is lengthened.
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An early Phase II randomised controlled trial testing the effect on
persecutory delusions of using CBT to reduce negative cognitions about
the self: The potential benets of enhancing self condence
Daniel Freeman
a,
, Katherine Pugh
b
, Graham Dunn
c,d
, Nicole Evans
a
, Bryony Sheaves
a
, Felicity Waite
a
,
Emma Černis
a
, Rachel Lister
a
,DavidFowler
b,e
a
Department of Psychiatry, University of Oxford, UK
b
Sussex Partnership NHS Foundation Trust, UK
c
Centre for Biostatistics, Institute of Population Health, University of Manchester, UK
d
MRC NW Hub for Trials Methodology Research, UK
e
Department of Psychology, University of Sussex, UK
abstractarticle info
Article history:
Received 29 July 2014
Received in revised form 15 October 2014
Accepted 27 October 2014
Available online 11 November 2014
Keywords:
Paranoia
Delusions
Self-esteem
Well-being
Clinical trial
Background: Research has shown that paranoia may directly build on negative ideas about the self. Feeling
inferior can lead to ideas of vulnerability. The clinical prediction is that decreasing negative self cognitions will
reduce paranoia.
Method: Thirty patients with persistent persecutory delusions were randomised to receive brief CBT in
addition to standard care or to standard care (ISRCTN06118265). The six session intervention was designed
to decrease negative, and increase positive, self cognitions. Assessments at baseline, 8 weeks (posttreatment)
and 12 weeks were carried out by a rater blind to allocation. The primary outcomes were posttreatment scores
for negativeself beliefs and paranoia. Secondary outcomes were psychological well-being, positive beliefs about
the self, persecutory delusions, social comparison, self-esteem, anxiety, and depression.
Results: Trial recruitment and retention were feasible and the intervention highly acceptable to the patients.
All patients provided follow-up data. Posttreatment there was a small reduction in negative self beliefs
(Cohen's d= 0.24) and a moderate reduction in paranoia (d=0.59),butthesewerenotstatistically
signicant. There were statistically signicant improvements in psychological well-being (d= 1.16),
positive beliefs about the self (d= 1.00), negative social comparison (d= 0.88), self-esteem (d=0.62),
and depression (d= 0.68). No improvements were maintained. No adverse events were associated with
the intervention.
Conclusions: The intervention produced short-term gains consistent with the prediction that improving
cognitions about the self will reduce persecutory delusions. The improvement in psychological well-being is
important in its own right. We recommend that the different elements of the intervention are tested separately
and that the treatment is lengthened.
© 2014 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/3.0/).
1. Introduction
Persecutory delusions are one of the key psychotic experiences.
Existing treatments for psychotic experiences, pharmacological and
psychological, are only partially effective (Leucht et al., 2013; van der
Gaag et al., 2014). Our approach to developing a much more efcacious
treatment is to target the main mechanisms causing the delusions.
We take a step by step approach to translation of the advances in
understanding persecutory delusions (Freeman and Garety, 2014),
based upon an interventionist-causal model approach (Kendler and
Campbell, 2009). One of the putative causal factors with the greatest
empirical support is negative beliefs about the self (Freeman et al.,
2002; Kesting and Lincoln, 2013; Tiernan et al., 2014). Therefore in the
current study we aimed to reduce negative thoughts about the self in
order to test the effect on clinical paranoia.
Negative thoughts about the self can lead to feelings of being
different, apart, inferior and hence vulnerable, a perspective central to
the theoretical conceptualisation of the paranoia hierarchy (see Fig. 1)
(Freeman et al., 2005). Paranoia will ourish when an individual
perceives him or herself as vulnerable. Three recent systematic reviews
have established that paranoia is associated with negative cognitions
about the self (Garety and Freeman, 2013; Kesting and Lincoln, 2013;
Schizophrenia Research 160 (2014) 186192
Corresponding author at: Oxford Cognitive Approaches to Psychosis, University
Department of Psychiatry, University of Oxford,Warneford Hospital, Oxford OX3 7JX, UK.
E-mail address: daniel.freeman@psych.ox.ac.uk (D. Freeman).
http://dx.doi.org/10.1016/j.schres.2014.10.038
0920-9964/© 2014 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/3.0/).
Contents lists available at ScienceDirect
Schizophrenia Research
journal homepage: www.elsevier.com/locate/schres
Tiernan et al., 2014). There is also longitudinal and experimental
support. In a study of 301 patients with psychosis assessed three
times over 12 months, negative cognitions about the self predicted
the persistence of persecutory delusions, with little evidence of reverse
causation (Fowler et al., 2012). A study of sixty patients with persecuto-
ry delusions showed that negative beliefs about the self predicted the
persistence of paranoia over the next six months (Vorontsova et al.,
2013). In an experimental study using virtual reality it was shown
that increasing negative views of the self leads to anincrease in paranoia
in vulnerable individuals (Freeman et al., 2014a). There are numerous
other reports of links between negative self-concepts and paranoia
(Bentall et al., 2009; Hutton et al., 2013; Lincoln et al., 2013; Atherton
et al., in press). Adverse experiences and environments will have a
major contribution to the development of negative self-concepts (e.g.
Selten and Cantor-Graae, 2005; Gracie et al., 2007; Bentall et al., 2012).
The clinical implication is that reducing negative thoughts about
the self will lead to reductions in persecutory delusions. Consistent
with this, self-esteem interventions for patients with psychosis have
also been shown to lead to improvements in positive symptoms
(e.g. Lecomte et al., 1999; Hall and Tarrier, 2003). These studies have
not examined persecutory delusions specically. We set-out to reduce
the short-term negative self-cognitions in patients with persistent
persecutory delusions. Our view is that concepts such as negative self
cognitions, self-esteem, and negative social comparison are closely
related phenomena, tiedto levels of depression.Therefore we measured
all of these concepts. The evaluation was an early Phase II clinical trial,
but with similarities to an experimental test. We used both standard
CBT techniques for negative thoughts but also techniques from
positive psychology to increase positive thoughts about the self
(Freeman and Freeman, 2012); this was on the basis of clinical experi-
ence and research that shows that negative and positive affect are
inversely correlated and overlap in genetic and environmental causes
(e.g. Kendler et al., 2011; Nes et al., 2013). That is, our approach was
to try to diminish negative thoughts and build positive thoughts. This
is consistent with Woods and Tarrier's (2010) argument that positive
and negative characteristics cannot logically be studied or changed
in isolation. The primary hypothesis was that a brief intervention
focused on reducing negative beliefs about the self would immediately
post-treatment produce reductions both in negative beliefs and in
paranoia. The secondary prediction was that there would be improve-
ments in related variables: positive beliefs about the self, comparison
of self to others, self esteem, well-being, anxiety, and depression.
Of course improvements in well-being and depression in this group
would be valuable irrespective of effects on paranoia; almost half of
patients with persecutory delusions have well-being scores in the
lowest 2% of the population (Freeman et al., 2014b) and a similar
proportion meet diagnostic criteria for depression (Vorontsova
et al., 2013). We also examined whether any improvements due to
treatment would be maintained at a follow-up assessment, although
at this stage of intervention development we were focussed upon
immediate change with treatment.
2. Method
2.1. Participants
30 patients were recruited from Oxford Health NHS Foundation
Trust. The inclusion criteria were: a current persecutory delusion
as dened by Freeman and Garety (2000); scoring at least 3 on the
conviction scale of the PSYRATS (Haddock et al., 1999); the delusion
had persisted for at least three months; a clinical diagnosis of
schizophrenia, schizoaffective disorder or delusional disorder (i.e. a
diagnosis of non-affective psychosis); negative beliefs about the
self as indicated by endorsing at least one negative schematic belief
on the Brief Core Schema Scale (BCSS; Fowler et al., 2006); aged
between 18 and 70; and where major changes in medication are
being made, entry to the study would not occur until at least a month
after stabilisation of dosage. The exclusion criteria were: a primary
diagnosis of alcohol or substance dependency; organic syndrome
or learning disability; a command of spoken English inadequate
for engaging in therapy or the assessments; and currently having
individual CBT (though previous experience of CBT was not an
exclusion criterion). Recruitment into the study is summarised in
the CONSORT diagram (see Fig. 2). It took place from September 2012
Fig. 1. The paranoia hierarchy (Freeman et al., 2005).
187D. Freeman et al. / Schizophrenia Research 160 (2014) 186192
to March 2014 (though not continuously), with nal data collection
completed in May 2014. It is of note that no patient with a persecutory
delusion was excluded on the basis of not endorsing at least one
negative schematic belief on the BCSS.
2.2. Research design
The study was a randomised controlled evaluation. Patients with
persecutory delusions were randomised to the CBT intervention in
addition to standard care or to standard care. Randomisation was
carried out in a 1:1 ratio using varying randomised permuted blocks
via a sequence obtained from www.randomization.com, which was
conducted by a researcher independent of the recruitment and assess-
ment process. Random allocation followed completion of the baseline
assessment. Informing patients of allocation was carried out by the
trial therapists, who opened an allocation envelope. Assessments were
carried out by a rater, a graduate psychologist (NE), blind to allocation.
Precautionary strategies included: the therapist being encouraged to
consider room use and diary arrangements in the light of potential
breaks of masking patients being reminded by the assessor not to
talk about treatment allocation and, after the initial assessment, the
assessor did not look at the patients' clinical notes until the last of
the ratings had been collected. If a blind was broken then another
researcher within the team carried out the assessment. 28 out of 29
eight week assessments were carried out blind and all 12 week
assessments were carried out blind. The assessment measures
were completed at 0 weeks (baseline), 8 weeks (end of therapy),
and at 12 weeks (a one month follow-up). The study had received
approval from an NHS research ethics committee and was registered
(ISRCTN06118265).
Fig. 2. Flow diagram of patient recruitment and trial progress.
188 D. Freeman et al. / Schizophrenia Research 160 (2014) 186192
2.3. Planned interventions
The intervention was described to patients as having the aim of
improving self-condence, and was provided in six sessions to each
individual over eight weeks. It was provided by clinical psychologists
(DF, KP, BS, FW), with occasional support from a graduate psychologist
(EC, RL) particularly for helping patients with tasks between sessions
(e.g. going outside to doan activity). The strategies used were indicated
in the literature to be effective at reducing negative beliefs about the
self and boosting positive beliefs (and did not challenge or review the
delusion itself). The strategies are described in detail in You Can
Be Happy (Freeman and Freeman, 2012), which was provided for a
number of therapy patients. The intervention is designed to provide
clear and simple messages for patients to take into their day-to-day
lives. There was an explicit agenda made with the patient to focus
upon three areas: 1. negative thoughts about the self, 2. positive
activities, and 3. positive thoughts about the self. Negative thoughts
about the self were normalised, made understandable in the context
of a person's experiences, and reviewed. Where voices were encourag-
ing negative thoughts about the self the patient was helped to see this
as a poor source of information and to disengage attention. Written
accounts by other patients were provided. Activities were structured
around the concept of ve-a-day for mental well-being (Foresight
Mental Capital and Wellbeing Project, 2008): connect, be active, take
notice, keep learning, and give. The aim was to increase the number
of these activities a patient did during the week. Positive thoughts
were encouraged by reviewing the person's strengths, savouring,
and keeping a diary of positive events. Positive music and pictures
were also used. The patients wanted to focus on improving their
self-condence but in the instances where paranoid thoughts were
brought up then the therapist would empathise with the distress and
the self-condence techniques would be framed as a way of building
up strength to help deal with the difcult events occurring in the
person's life. Tasks were set between sessions and there were support-
ive telephone calls or texts, and a graduate psychologist could visit to
help with carrying out of an activity. Throughout the intervention the
person's main negative self-belief and a positive self-belief were
measured to monitor progress. All trial patients continued to receive
standard care. Standard care was delivered according to national and
local service protocols and guidelines. It usually consisted of prescrip-
tion of anti-psychotic medication, visits from a community mental
health worker, and regular outpatient appointments with a psychiatrist.
2.4. Primary outcome measures
2.4.1. Brief Core Schema Scales (BCSS) (Fowler et al., 2006)
The self-report BCSS, developed with non-clinical and psychosis
groups, has 24 items assessing negative and positive beliefs about the
self and others each rated on a ve-point scale (04). Higher scores
reect greater endorsement of items. The sub-scales of interest in the
current study were negative beliefs about self, which contains six
items (e.g. I am unloved’‘I am worthless’‘Iamweak), and positive
beliefs about self, which contains six items (e.g. I am respected’‘Iam
valuable’‘I am talented).
2.4.2. Green et al. Paranoid Thoughts Scale (GPTS; Green et al., 2008)
The GPTS is a thirty-two item self-report measure of paranoid
thinking, designed for both clinical and non-clinical populations.
Part A assesses ideas of reference (e.g. It was hard to stop thinking
about people talking about me behind my back) and Part B assesses
ideas of persecution (e.g. I was convinced there was a conspiracy
against me). Each item is rated on a 5-point scale. It was completed
for the time period of the past fortnight. Higher scores indicate greater
levels of paranoid thinking.
2.5. Secondary outcome measures
2.5.1. Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Tennant
et al., 2007)
The WEMWBS is a fourteen item scale assessing well-being over the
past fortnight. Each item is rated on a 1 (none of the time) to 5 (all of the
time) scale, and therefore the total score can range from 14 to 70, with
higher scores indicating a greater level of well-being. Example items
are: I've been feeling optimistic about the future; I've been feeling
useful; I've been feeling relaxed; I've been feeling good about myself;
I've been feeling condent; I've been feeling loved; and I've been feeling
cheerful. The scale has high test-test reliability and criterion validity
with other wellbeing scales.
2.5.2. Social Comparison Scale (Allan and Gilbert, 1995)
This measure comprises eleven bipolar scales, to which we added
eight further items: Inferiorsuperior, Incompetentcompetent,
unlikeablelikeable, left outaccepted, differentsame, untalented
more talented, weakerstronger, uncondentmore condent, undesir-
ablemore desirable, unattractivemore attractive, outsiderinsider,
powerlesspowerful, unrespectedrespected, foolishsensible, odd
normal, a failurea success, low in self esteemhigh in self esteem, a
bad persona good person, and unlike other peoplelike other people.
Each was rated on a 0100 scale. Cronbach's alpha for the full scale at
each assessment time point was .93, .94, and .97, respectively. Higher
scores indicate a more positive view of the self in relation to others.
2.5.3. Psychotic Symptom Rating ScalesDelusions (PSYRATS) (Haddock
et al., 1999)
The PSYRATS-Delusions scale is a six item multidimensional
measure. It assesses the conviction, preoccupation, distress and
disruption associated with delusions. Symptoms over the last week
are rated. Higher scores indicate greater severity.
2.5.4. Robson Self-Concept Questionnaire (RSQ) (Robson, 1989)
This is a 30 item self-report scale, with each item rated on a 0
(completely disagree) to 7 (completely agree) scale. Higher scores
indicate higher self-esteem.
2.5.5. Beck Anxiety Inventory (BAI) (Beck et al., 1988)
The BAI is a self-report 21-item, four point (03) scale for the
assessment of anxiety over the past week. Higher scores indicate
higher levels of anxiety.
2.5.6. Beck Depression Inventory-II (BDI) (Beck et al., 1996)
The BDI-II is a self-report 21-item, four point scale (03) for the
assessment of depression over thepast fortnight. Higher scores indicate
higher depression.
2.6. Adverse events
During the trial any adverse event that came to our attention was
recorded. Medical notes were also examined at the end of the trial for
the following events pre-specied as adverse: 1. All deaths. 2. Suicide
attempts. 3. Serious violent incidents. 4. Admissions to secure units.
5. Formal complaints about therapy. Psychiatric hospital admissions
were also recorded.
2.7. Statistical analysis
All analyses were carried out using Stata version 13 (Statacorp,
2013). All main analyses were carried out at the end of the last follow-
up assessments and were based on the intention-to-treat principle.
Analysis of covariance was carried out for each outcome variable,
separately for 8 and 12 week assessment points. The effect of group
allocation was tested, controlling for the appropriate baseline measure.
189D. Freeman et al. / Schizophrenia Research 160 (2014) 186192
At this stage of evaluation, condence intervals for change and effect
sizes are of most interest, not probability values. No formal power
calculations were considered relevant. Effect sizes were calculated
using Cohen's d, taking the estimated coefcient of treatment allocation
from the ANCOVA divided by the pooled baseline standard deviation.
The study target sample size was thirty patients, which would allow
detection of large clinical effects.
3. Results
3.1. Basic demographic and clinical data
Table 1 provides detail ofbasic demographic and clinicalinformation
about the patients. The majority of patients had a clinical diagnosis
of schizophrenia, they were all outpatients, and all were taking
neuroleptic medication.
3.2. Up-take of therapy
All of the patients received the intervention. Eleven patients in the
treatment group received six CBT sessions, and the intervention was
provided in seven sessions for four patients. Comments from patients
who had the intervention are provided in Table 2.
3.3. Outcomes
The scores of the allocation groups for each assessment at each
time point are displayed in Table 3. It can be seen that at posttreatment
eight of the nine assessment variables showed signs of improvement
with treatment, ranging from small to large effects. Five out of nine
posttreatment tests reached statistical signicance, with the treatment
group beneting in each case. For the primary measures there was a
small effect size reduction in negative beliefs about the self and a mod-
erate effect size reduction in paranoia, neither of which was statistically
signicant. For the secondary outcomes there were notable improve-
ments in psychological well-being, positive beliefs about the self, self-
esteem, social comparison, and depression. Anxiety levels were slightly
lower in the control group posttreatment. No benets of treatment
were maintained at the 12 week assessment.
3.4. Admissions and adverse events
From medical notes it was found that one patient in each allocation
group had an admission to psychiatric hospital during the trial.
One patient, in the control group, made a suicide attempt. There
were no deaths, serious violent incidents, admissions to forensic
wards, or formal complaints about therapy.
4. Discussion
There is clear evidence from longitudinal and experimental studies
that negative cognitions about the self are a putative causal factor in
paranoia (e.g. Fowler et al., 2012; Lincoln et al., 2013; Vorontsova
et al., 2013; Freeman et al., 2014a). We set-out to test this directly in
patients with persecutory delusions. The interest at this stage was the
immediate effects of targeting cognitions about the self. We did not
try to determine which specic intervention techniques may change
the mechanism. This focus on mechanism change is similar to an exper-
imental study, though closest to a Phase II early clinical trial. The evalu-
ation proved feasible, acceptable, and had good methodological rigour
for an early stage test: assessments were blind, all patients attended
all therapy sessions, and there was an exceptionally high follow-up
rate. There were importantgains for the patients withCBT in psycholog-
ical well-being, depression, positive beliefs about the self, self-esteem,
and social comparison. There were small improvements in negative
beliefs about the self. As predicted there were also improvements in
overall levels of paranoiaand the main persistent persecutory delusions,
althoughthese did not reach statistical signicance. Ourview is that this
indicates the potential value of targeting negative cognitions in patients
with persecutory delusions.
The patients all had delusions that had persisted for a considerable
period of time despite medication. Other psychotic experiences such
as auditory hallucinations were very common. The therapy was very
well-received: all patients attended all the sessions. Indeed there was
a general readiness of patients to attend further treatment sessions.
We found that positive psychology techniques and activity were most
used, with much less work directly on negative views about the self.
Patients appreciated a shift of focus away from their problems towards
their strengths. The improvements in psychological well-being during
the trial are notable and are clearly important in their own right as an
outcome. This work is likely to have wider applicability to patients
with psychosis. Nonetheless it may be argued that this therapy focus
led to less change in negative self cognitions, which may have the
closest connections to paranoid ideation. Measurement issues may
also be important here, since the Brief Core Schema Scale (Fowler
et al., 2006) was not developed as an outcome scale, whereas the
Warwick Edinburgh Mental Well-Being Scale (Tennant et al., 2007)is
well-received by patients. Further, we are struck by the gains not
Table 1
Basic demographic and clinical data.
Treatment group
(n= 15)
Control group
(n= 15)
Mean age in years (SD) 41.9 (11.5) 41.5 (13.1)
Male; female 11; 4 9; 6
Ethnicity:
White 15 13
Other 0 2
Employment status:
unemployed
13 13
Part-time employed 0 0
Full-time employed 1 1
Self employed 0 0
Retired 0 0
Student 1 1
Diagnosis:
schizophrenia
12 10
Schizo-affective disorder 2 4
Delusional disorder 0 1
Psychosis NOS 1 0
Mean chlorpromazine equivalent
medication dose (SD)
597.8 (355.6) 534.4 (424.7)
Table 2
Illustrative patient comments on the intervention.
Patient 1
I thought it was excellent. My self-condence has got better and I think more
positively. Before, everything seemed like a really big problem and I worried a
lot. I do still worry, but I tell myself I can't do anything about it so I write it down
instead. I'm feeling really good at the moment.
Patient 2
Things are good now. I'm now able to help my wife more, it's easier to spend
time with my grandchildren and I'm much more patient. I went to see my
psychiatrist last week and he said I'm the best he's ever seen me. It was really
helpful to talk about the personal stuff for the rst time and sharing it with
someone who understands. It was tough but it's gotta get bad before it gets
better. When I spoke to my daughter she thought it was too tough, but
something inside me told me to keep going. I'm really glad I did.
Patient 3
I think I am more condent and I have a slightly different bearing. The way I feel
in myself and the way I am in myself. I feel more condent, a general sense of
being more condentIt really helped me to reverse the balance and swing the
pendulum back. It's such a change to think about strengths after years of going to
the doctors and saying what's wrong. I've started giving my doctor and care
co-ordinator that I meet a copy of my CV with my education, work I've done and
voluntary experience on. I tell them that this is the me that you don't see when
I'm well.
190 D. Freeman et al. / Schizophrenia Research 160 (2014) 186192
being maintained. Although our focus was on short-term change, we
still expected gains to last. Our other brief interventions have main-
tained treatment gains over several months (Freeman et al., submitted
for publication). Given the theoretical and research foundations for
the link between negative self cognitionsand paranoia, and the promise
of the current study, we believe that this treatment development needs
to be pursued. Our recommendations are that intervention needs to be
lengthened, the targeting of negative cognitions and positive cognitions
needs to be directly compared, and that an attention control condition
would add strength to the judgements that can be reached. Negative
self cognitions in patients with severe paranoia are likely to reect
deeply engrained self views which relate to appraisals of negative expe-
riences over the life course, and may indeed be maintained by ongoing
adverse experiences andsocial circumstances. How to improve negative
cognitions in patients with paranoia is likely to prove an area of key in-
terest inthe future. We expectsuch treatment approaches infuture clin-
ical practice to be combined with interventions that target other key
causal factors in paranoia (Freeman and Garety, 2014).
Role of funding source
The study wasincluded as part of a programmeof research within a MedicalResearch
Council (MRC) Senior Clinical Fellowship awarded to Daniel Freeman. It was therefore
reviewed by the MRC before it was carried out. The funder has not had any subsequent
involvement and has not seen the trial results.
Contributors
Daniel Freeman, David Fowler and Graham Dunn designed the study. Therapy was
carried out by Dan iel Freeman, Katherine Pugh, Br yony Sheaves, and Felicity Waite.
Recruitment and assessments were carried out by Nicole Evans, Emma Černis, and Rachel
Lister. Katherine Pugh was the trial co-ordinator. Graham Dunn carried out the analysis.
Daniel Freeman took responsibility for drafting the paper. All authors commented upon
the nal manuscript.
Conict of interest
None.
Acknowledgements
The study was funded by a Medical Resear ch Council Senior Clinical Fellowship
(G0902308) awarded to Daniel Freeman.
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Table 3
The outcome measure scores at each assessment time.
Treatment group Control group
nMean SD nMean SD Coefcient 95% C.I. tp-value Effect size
Negative self (BCSS) 0 weeks 15 11.1 6.5 15 12.5 4.3
Negative self (BCSS) 8 weeks 15 6.4 4.7 14 8.1 3.7 1.3 4.0, 1.5 0.95 .353 0.24
Negative self (BCSS) 12 weeks 15 7.6 5.3 15 8.1 5.6 0.1 3.6, 3.9 0.07 .944
Paranoia (GPTS) 0 weeks 15 103.7 25.2 15 117.8 24.1
Paranoia (GPTS) 8 weeks 15 82.3 32.2 14 106.3 203 14.9 33.1, 3.3 1.68 .105 0.59
Paranoia (GPTS) 12 weeks 15 84.4 31.6 15 98.6 28.3 4.8 24.9, 15.2 0.50 .624
Positive self (BCSS) 0 weeks 15 4.1 4.4 15 3.7 4.0
Positive self (BCSS) 8 weeks 15 8.6 4.4 14 4.4 2.8 4.1 1.6, 6.7 3.33 .003 1.00
Positive self (BCSS) 12 weeks 15 7.3 5.4 15 6.3 4.8 0.7 2.5, 3.9 0.45 .657
Social comparison (SCS) 0 weeks 15 433.8 287.3 15 408.1 193.9
Social comparison (SCS) 8 weeks 15 903.7 326.8 14 678.1 239.1 211.8 24.3, 399.4 2.32 .028 0.88
Social comparison (SCS) 12 weeks 15 754.8 406.6 15 636.0 311.9 104.6 152.2, 361.3 0.84 .411
Delusion (PSYRATS) 0 weeks 15 18.4 2.9 15 18.1 2.9
Delusion (PSYRATS) 8 weeks 15 14.3 6.0 14 16.7 3.3 2.6 5.9, 0.7 1.64 .113 0.91
Delusion (PSYRATS) 12 weeks 15 15.1 4.9 15 13.7 5.4 1.0 2.1, 4.2 0.68 .502
Self esteem (RSQ) 0 weeks 15 73.9 26.3 15 70.0 23.1
Self esteem (RSQ) 8 weeks 15 99.9 21.6 14 82.9 25.6 15.2 3.0, 27.4 2.56 .017 0.62
Self esteem (RSQ) 12 weeks 15 95.3 25.9 15 83.1 30.9 9.0 6.5, 24.5 1.20 .242
Well-being (WEMWBS) 0 weeks 15 30.3 6.4 15 30.1 6.6
Well-being (WEMWBS) 8 weeks 15 41.0 7.2 14 33.5 7.3 7.4 2.2, 12.6 2.94 .007 1.16
Well-being (WEMWBS) 12 weeks 15 39.4 10.6 15 33.3 9.7 6.0 1.0, 13.0 1.76 .089
Anxiety (BAI) 0 weeks 15 28.8 15.4 15 25.1 7.6
Anxiety (BAI) 8 weeks 15 23.6 12.8 14 19.4 8.1 2.1 4.4, 8.7 0.67 .507 0.21
Anxiety (BAI) 12 weeks 15 22.9 15.3 15 21.5 7.1 1.8 6.5, 3.0 0.76 .452
Depression (BDI) 0 weeks 15 32.1 11.8 15 35.1 8.4
Depression (BDI) 8 weeks 15 21.3 9.9 14 29.1 9.0 6.9 13.3, 0.4 2.19 .037 0.68
Depression (BDI) 12 weeks 15 22.9 12.6 15 27.3 9.5 2.3 9.0, 4.4 0.70 .492
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... Next, detailed results are described for each theme. [55][56][57][58][59][60][61][62][63]; (4) 18 cognitive behavioural therapy (CBT) studies [64][65][66][67][68][69][70][71][72][73][74][75][76][77][78][79][80][81]; and (5) 19 studies of other therapy interventions including Acceptance and Commitment Therapy (n = 4) [84,92,93,96], counselling (n = 4) [85,86,94,95], pet therapy (n = 2) [88,90], solution-focused brief therapy (n = 2) [97,98] and other unique therapy types [82,83,89,91,99,100]. Study details are provided in Supplemental File S4A. ...
... In contrast, four of eight mindfulness and eight of eleven CBT interventions reported better wellbeing in the intervention groups compared to control. The largest improvements in wellbeing were in courses and programmes with a greater number of sessions (e.g., range: 4-20) taking place over a longer period (e.g., over 6+ weeks) [21,28,50,52, [54][55][56]62,70]. Figure 3 shows forest plots across the four main sub-themes. Fifteen of 18 resilience, self-management and wellness studies were included in the meta-analysis of standardised mean differences between pre and post-intervention, revealing a large impact of these interventions on wellbeing (SMD = 0.72 (0.42, 1.02)). ...
... Due to the breadth of studies captured in this review, it is unsurprising that certain interventions had substantially larger impacts than others on wellbeing. Bigger improvements in wellbeing were commonly observed in studies with longer interventions (e.g., weekly sessions for 6-12 weeks) compared to single sessions [50,52,[54][55][56]62,70,162,163,166]. ...
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Objectives: SlowMo therapy is a pioneering blended digital therapy for paranoia, augmenting face-to-face therapy with an interactive 'webapp' and a mobile app. A recent large-scale trial demonstrated small-moderate effects on paranoia alongside improvements in self-esteem, worry, well-being and quality of life. This paper provides a comprehensive account of therapy personalisation within this targeted approach. Design: Case examples illustrate therapy delivery and descriptive data are presented on personalised thought content. Method: Thought content was extracted from the webapp (n = 140 participants) and coded using newly devised categories: Worries: (1) Persecutory, (2) Negative social evaluation, (3) Negative self-concept, (4) Loss/life stresses, (5) Sensory-perceptual experiences and (6) Health anxieties. Safer thoughts: (1) Safer alternative (specific alternatives to worries), (2) Second-wave (generalised) coping, (3) Positive self-concept, (4) Positive activities and (5) Third-wave (mindfulness-based) coping. Data on therapy fidelity are also presented. Results: Worries: 'Persecutory' (92.9% of people) and 'Negative social evaluation' (74.3%) were most common. 'General worries/ life stresses' (31.4%) and 'Negative self-concept' (22.1%) were present in a significant minority; 'Health anxieties' (10%) and 'Sensory-perceptual' (10%) were less common. Safer thoughts: 'Second-wave (general) coping' (85%), 'Safer alternatives' (76.4%), 'Positive self-concept' (65.7%) and 'Positive activities' (64.3%) were common with 'Third-wave' (mindfulness) coping observed for 30%. Fidelity: Only three therapy withdrawals were therapy related. Session adherence was excellent (mean = 15.2/16; SD = 0.9). Behavioural work was conducted with 71% of people (119/168). Conclusion: SlowMo therapy delivers a targeted yet personalised approach. Potential mechanisms of action extend beyond reasoning. Implications for cognitive models of paranoia and causal interventionist approaches are discussed.
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worry might be a contributory causal factor in the occurrence of persecutory delusions in patients with psychotic disorders. Therefore we postulated that reducing worry with cognitive behaviour therapy (CBT) would reduce persecutory delusions. Methods: for our two-arm, assessor-blinded, randomised controlled trial (Worry Intervention Trial [WIT]), we recruited patients aged 18–65 years with persistent persecutory delusions but non-affective psychosis from two centres: the Oxford Health National Health Service (NHS) Foundation Trust (Oxford, UK) and the Southern Health NHS Foundation Trust (Southampton, UK). The key inclusion criteria for participants were a score of at least 3 on the Psychotic Symptoms Rating Scale (PSYRATS) denoting a current persecutory delusion; that the delusion had persisted for at least 3 months; a clinical diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder; and a clinically significant level of worry. We randomly assigned (1:1) eligible patients, using a randomly permuted block procedure with variable block sizes and division by four strata, to either six sessions of worry-reduction CBT intervention done over 8 weeks added to standard care (the CBT-intervention group), or to standard care alone (the control group). The assessors were masked to patient allocations and did their assessments at week 0 (baseline), 8 weeks (end of treatment), and 24 weeks, follow-up. The primary outcomes were worry measured by the Penn State Worry Questionnaire (PSWQ) and delusions measured by the PSYRATS-delusion scale; we did the analyses in the intention-to-treat population, and also did a planned mediation analysis. This trial is registered with the ISRCTN Registry (number ISRCTN23197625) and is closed to new participants. Findings: from Nov 1, 2011, to Sept 9, 2013, we recruited 150 eligible participants and randomly assigned 73 to the CBT intervention group, and 77 to the control group. 143 patients (95%) provided primary outcome follow-up data. Compared with standard care alone, at 8 weeks the CBT intervention significantly reduced worry (mean difference 6·35 [SE 1·56] PSWQ units, 95% CI 3·30–9·40; p<0·001) and persecutory delusions (2·08 [SE 0·73] PSYRATS units, 95% CI 0·64–3·51; p=0·005). The reductions were maintained to 24 weeks follow-up. The mediation analysis suggested that the change in worry accounted for 66% of the change in delusion. No patients died or were admitted to secure units during our study. Six suicide attempts (two in the CBT intervention group, and four in the control group) and two serious violent incidents (one in each group) were noted, but no adverse events were deemed related to the treatments or the assessments. Interpretation: to our knowledge, this is the first large trial focused on persecutory delusions. We have shown that long-standing delusions were significantly reduced by a brief intervention targeted on worry, although the limitations for our study include no determination of the key elements within the intervention. Our results suggest that worry might cause paranoia, and that worry intervention techniques might be a beneficial addition to the standard treatment of psychosis. Funding: efficacy and Mechanism Evaluation programme, which is a UK Medical Research Council and National Institute of Health Research partnership.
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Purpose Persecutory delusions are a central psychotic experience, at the severe end of a paranoia spectrum in the general population. The aim of the review is to provide an introduction to the understanding of persecutory delusions, highlight key putative causal factors that have the potential to be translated into efficacious treatment, and indicate future research directions. Methods A narrative literature review was undertaken to highlight the main recent areas of empirical study concerning non-clinical and clinical paranoia. Results Six main proximal causal factors are identified: a worry thinking style, negative beliefs about the self, interpersonal sensitivity, sleep disturbance, anomalous internal experience, and reasoning biases. Each has plausible mechanistic links to the occurrence of paranoia. These causal factors may be influenced by a number of social circumstances, including adverse events, illicit drug use, and urban environments. Conclusions There have been numerous replicated empirical findings leading to a significant advance in the understanding of persecutory delusions, now beginning to be translated into cognitive treatments. The first trials specifically focussed on patients who have persecutory delusions in the context of psychotic diagnoses are occurring. Initial evidence of efficacy is very promising.
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Mistrust of others may build upon perceptions of the self as vulnerable, consistent with an association of paranoia with perceived lower social rank. Height is a marker of social status and authority. Therefore we tested the effect of manipulating height, as a proxy for social rank, on paranoia. Height was manipulated within an immersive virtual reality simulation. Sixty females who reported paranoia experienced a virtual reality train ride twice: at their normal and reduced height. Paranoia and social comparison were assessed. Reducing a person's height resulted in more negative views of the self in comparison with other people and increased levels of paranoia. The increase in paranoia was fully mediated by changes in social comparison. The study provides the first demonstration that reducing height in a social situation increases the occurrence of paranoia. The findings indicate that negative social comparison is a cause of mistrust.
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Background: Paranoia may build directly upon negative thoughts about the self. There have been few direct experimental tests of this hypothesis. Aims: The aim of the study was to test the immediate effects of manipulating self-esteem in individuals vulnerable to paranoia. Method: A two condition cross-over experimental test was conducted. The participants were 26 males reporting paranoid ideation in the past month. Each participant experienced a neutral immersive virtual reality (VR) social environment twice. Before VR participants received a low self-confidence manipulation or a high self-confidence manipulation. The order of manipulation type was randomized. Paranoia about the VR avatars was assessed. Results: The low self-confidence manipulation, relative to the high self-confidence manipulation, led to significantly more negative social comparison in virtual reality and higher levels of paranoia. Conclusions: Level of self-confidence affects the occurrence of paranoia in vulnerable individuals. The clinical implication is that interventions designed to improve self-confidence may reduce persecutory ideation.