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A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): Study protocol for a randomized controlled trial


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Background Existing psychological therapies for bipolar disorders have been found to have mixed results, with a consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed ‘Think Effectively About Mood Swings’ (TEAMS) addresses current symptoms, including subclinical hypomania, depression and anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies testing the model and a case series have demonstrated positive results. The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial. Methods/Design A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression, anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms, medication, access to services and quality of life are conducted by assessors blind to treatment condition at 3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization. The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up. The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach. Discussion The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual. Trial registration This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.
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S T U D Y P R O T O C O L Open Access
A novel cognitive behaviour therapy for bipolar
disorders (Think Effectively About Mood Swings
or TEAMS): study protocol for a randomized
controlled trial
Warren Mansell
, Sara Tai
, Alexandra Clark
, Savas Akgonul
, Graham Dunn
, Linda Davies
, Heather Law
Richard Morriss
, Neil Tinning
and Anthony P Morrison
Background: Existing psychological therapies for bipolar disorders have been found to have mixed results, with a
consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have
focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed Think
Effectively About Mood Swings(TEAMS) addresses current symptoms, including subclinical hypomania, depression and
anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies
testing the model and a case series have demonstrated positive results. The current study reports the protocol of a
feasibility randomized controlled trial to inform a future multi-centre trial.
Methods/Design: A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder
not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions
of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression,
anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms,
medication, access to services and quality of life are conducted by assessors blind to treatment condition at
3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into
both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that
TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization.
The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar
cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up.
The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience
of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach.
Discussion: The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and
barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual.
Trial registration: This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.
Keywords: Cognitive behavioral therapy, Controlled trial, Bipolar disorder, Recovery
* Correspondence:
The Psychosis Research Unit, GMW Mental Health NHS Foundation Trust,
Harrop House, Bury New Road, Prestwich, Manchester M25 3BL, UK
Full list of author information is available at the end of the article
© 2014 Mansell et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver ( applies to the data made available in this article,
unless otherwise stated.
Mansell et al. Trials 2014, 15:405
Bipolar disorders are characterized by periods of depres-
sion and periods of elated or irritable mood (mania or
hypomania), with around 2 to 6% of the general popula-
tion meeting the criteria for diagnosis [1,2]. The cost of
bipolar disorders annually in the UK is £5.2 billion, pro-
jected to rise to £8.2 billion by 2026. Despite treatment,
people with bipolar disorders remain depressed for the
majority of time when not experiencing an episode. After
apparent recovery from a bipolar episode, subsyndromal
symptoms of depression remain in the long term, esti-
mated at 30 to 50% of subsequent weeks [3,4]. Depres-
sive symptoms form the largest contribution to impaired
functioning in bipolar disorder [5,6]. At present, anti-
depressant treatment is relatively ineffective for these indi-
viduals [7].
There is a clear need for a more effective, cost-efficient
intervention such as CBT (cognitive behavioral therapy).
A number of reviews and meta-analyses of existing
psychological interventions for bipolar disorders dem-
onstrate mixed outcomes; yet overall, there are signifi-
cant but modest effects [8-10]. A similar mixed set of
outcomes were found in the most recently published trials,
with most participants continuing to experience significant
sub-clinical symptoms and disruption to life-functioning
after receiving an intervention [11-13]. Thus, there remains
a need for an alternative approach to managing bipolar dis-
orders. Our group has been developing and piloting a case
series for a new CBT approach known as TEAMS (Think
Effectively About Mood Swings) based on an empirically
supported model [14]. It involves a new integrative treat-
ment approach that has the potential to benefit those
people whose symptoms of depression, hypomania and
anxiety have otherwise remained treatment-resistant and/
or those with reduced functioning.
Our approach specifically targets current problems as
specific to the patient, in contrast to earlier forms of CBT
for bipolar disorder that have focused on preventing future
relapse. In a range of other psychiatric disorders, CBT is
also designed to work on current problems. Treatment is
focused on developing a formulation (a shared under-
standing) of how thinking styles and behaviors maintain
and escalate current symptoms, such as unipolar depres-
sion [15,16], anxiety disorders [17,18] and eating disorders
[19]. In our own research, people diagnosed with bipolar
disorders reported that their recovery involved not simply
remaining free of relapse, but also regaining a sense of
purpose in their lives and facing their longstanding prob-
lems [20,21].
Therefore, the cognitive model [22] that guides TEAMS
focuses on understanding what is maintaining peoples
current problems, such as anxiety, depression and irritabil-
ity, and facilitates people regaining control over their lives.
The model proposes that people with bipolar disorders
experience mood difficulties because they strive to control
their mood in extreme ways, which negatively affects their
ability to control and achieve their broader goals in life. As
such, their mood rarely reaches a stable state and their at-
tempts to pursue their life goals are disrupted. The goal of
TEAMS is to help people to develop awareness of the ways
in which they manage their moods and develop alternative
ways in which to live a more fulfilling and balanced life.
The current study represents the fourth phase in the
development and testing of TEAMS. In the first phase,
we conducted a series of literature reviews [23-25] and
qualitative analyses of personal accounts [21,26] to in-
form our treatment model [22]. In the second phase, we
tested the model through a range of self-report, observa-
tional and experimental studies that provided strong evi-
dence for the central role of extreme appraisals of internal
states as a key mechanism in bipolar disorders and mood
swings [20,27,28]. In the third phase we reported a number
of case studies and a case series [29] that demonstrated
promising findings regarding acceptability and effect sizes,
and so established the rationale for a pilot randomized con-
trolled trial at the fourth stage. At this fourth stage it is im-
portant to establish whether there is evidence that TEAMS
added to usual care has evidence of clinical effectiveness of
usual care. Hence the TEAMS CBT will be compared to
usual care. The fifth stage is envisaged to be a multi-center,
definitive randomized controlled trial to establish a more
precise estimate of the clinical- and cost-effectiveness of the
intervention, as well as the generalizability of the results.
The study was approved by the London Queens-Square
Research Ethics Committee (REC reference: 11/LO/1326).
Our objective is to determine whether the TEAMS ap-
proach is feasible and acceptable to individuals with bipolar
disorder compared with treatment-as-usual and establish
an estimate of treatment effect size to inform a larger de-
finitive randomized controlled trial. We aim to assess the
feasibility and acceptability of, and information on uptake,
service barriers and attrition needed to design a definitive
randomized controlled trials. We predict that TEAMS will
reduce symptoms of depression, hypomania and anxiety,
improve social functioning and promote recovery in com-
parison to treatment-as-usual at six months post-baseline
(post-treatment in the TEAMS wing), and at 12 and 18-
months post-baseline. We also aim to evaluate the clinical-
and cost-effectiveness of an intervention which has the
potential for direct benefits for patients.
Trial design
A parallel group rater-blind randomized controlled trial
comparing treatment-as-usual with up to 16 sessions of
Mansell et al. Trials 2014, 15:405 Page 2 of 9
TEAMS therapy. Allocation to the two groups will be at
a ratio of 1:1 and have an exploratory framework. The
design for this study involves a quantitative component
(pilot trial) and a qualitative component (interviews with
patients and service providers, described later).
Primary outcome measure
The main objective of the pilot randomized control trial re-
lates to evaluation of recruitment and retention of partici-
pants into both arms of the study, as well as adherence to
therapy, to determine feasibility and acceptability. We pre-
dict that TEAMS will reduce depression in comparison to
treatment-as-usual at 6 and 12 months post-randomization,
with the Beck Depression Inventory [30] score at six months
as the primary outcome measure.
Secondary outcome measures
The secondary hypotheses are that TEAMS will reduce
the severity of hypomanic symptoms and anxiety, change
thinking styles responsible for maintaining symptoms
which will be targeted by the therapy, improve social func-
tioning and promote recovery compared to treatment-as-
usual at post-treatment and follow-up.
Several secondary outcome measures will be used: a
Structured Clinical Interview for Diagnosis Longitudinal
Interval Follow-up Evaluation (SCID-LIFE) interview for
episodes of mania or depression [31], interview measures
of manic symptoms (Bech-Rafaelson, [32]) and depression
[33], composite internal state scale score (ISS, [34]), anx-
iety as measured by the Generalised Anxiety Disorder 7
item scale GAD-7 [35], recovery as measured by the
Process of Recovery Questionnaire (QPR) [36], cognitive
style measured by the Hypomanic Attitudes and Positive
Predictions Inventory [37,38], the EuroQol Health Status
Measure (EQ-5D) [39] and session-by-session measures.
Raters were trained at the beginning of, and during the
study, in interview measures of outcome by an experi-
enced rater who is a consultant psychiatrist (RM), to im-
prove the reliability and validity of the ratings. Participants
are paid a fixed amount of expenses for their time (£10
per assessment after baseline) and travel for the follow-up
assessment sessions. If any participant withdraws from
treatment, we will seek permission to collect outcome
data. If a participant misses their assessment, they are con-
tacted a maximum of three times by the rater through the
means of contact that they have specified (such as a home
or mobile telephone, letter or care coordinator), after
which they are coded as missed and re-contacted for the
next follow-up point. Self-report measures are collected
where interview assessments are not possible.
Prior to each session, the clients complete the ISS and a
personalized 10 to 15 item Client version of the Hypomanic
Attitudes and Positive Predictions Inventory. (HAPPI)
(Client-HAPPI) which assesses their most prominent
beliefs about internal states [29]. At the end of each treat-
ment session, clients rate their level of satisfaction with
therapy on a Likert scale from 0 (not at all) to 10 (ex-
tremely). Adherence is evaluated by the widely used revised
version of the Cognitive Therapy Rating Scale (CTS-R)
[40], and a brief checklist of adherence specific to the
TEAMS model - The TEAMS Treatment Adherence
Checklist (T-TAC).
Think Effectively About Mood Swings therapy
The TEAMS approach involves an individualized treat-
ment plan of CBT based on the integrative cognitive model
of bipolar disorder [22]. Specific treatment strategies and
therapy techniques employed are determined by an indi-
vidual formulation using the model. There are several pub-
lished descriptions of the intervention, as well as a therapy
manual in development [14,22,29,41].
Control condition group
The control condition consists of treatment-as-usual which
typically involves regular meetings with a care coordinator,
access to a psychiatrist, medication and monitoring of risks
that require immediate intervention. Treatments, including
other psychological interventions, are not withheld in the
treatment-as-usual group but are monitored using a treat-
ment documentation sheet. Following written consent, par-
ticipants are randomized within two working days.
Randomization and blinding
The independent Manchester Academic Health Science
Centre Clinical Trials Unit conducts anonymized
randomization in a permuted blocks design with block
sizes varying randomly between 8 and 12. There is no
stratification of the sample, but baseline information may
be used in a post hoc manner to explore the effects of
baseline characteristics. The procedure is as follows. An
administrator contacts the clinical trials unit with a pass-
word and the participant identification number, and re-
ceives an allocation sequence to assign participants to
either group. The administrator then directly contacts par-
ticipants and therapists. Due to the nature of the trial only
a single blinding (of raters) is needed. Blindness of raters
is ensured using a variety of procedures, including separ-
ate offices for therapists and research assistants, brief-
ings to participants prior to assessment and encryption
of randomization information. Unblindings are regularly
monitored and recorded. Deliberate unblinding would
only occur if there was a serious adverse incident such as
suicide or violence to another person by a participant.
Sample size
The primary aim of this study is to evaluate feasibility,
therefore a formal power calculation is not appropriate.
However, estimates indicate that with 42 participants per
Mansell et al. Trials 2014, 15:405 Page 3 of 9
group, using a t-test with a two-tailed significance level
of 0.05, we will have over 80% power to detect an effect
size of 0.8. If the significance level were altered to 15%,
30 participants per group will have 80% power to detect
an effect size of 0.6. A previous case series of seven pa-
tients generated a pre-post effect size at one-month
follow-up on the primary outcome measure of 3.0, and
between 0.7 and 1.4 for the secondary measures [29].
The above information makes a feasibility trial of 30 par-
ticipants per group an appropriate target.
In aiming for 60 participants in total, the target re-
cruitment is 84 participants, allowing a 29% attrition rate
by the 12-month post-randomization point. This dropout
rate was based on a conservative estimation just above the
highest reported rate of attrition found in other published
studies of CBT for bipolar disorder (13 [42], 25 [43] and
21% [10]).
A total of 84 participants aged 16 years or over who meet
Diagnostic and Statistical Manual of Mental Disorders
Fourth Edition (DSM-IV) criteria for a diagnosis of bipolar
disorder will be recruited. Recruitment is taking place
across a number of NHS Trusts in and around Greater
Manchester. The lead Trust for the research is Greater
Manchester West Mental Health NHS Foundation Trust.
Advertisements, including posters and flyers, to pro-
mote the study have been distributed in Community
Mental Health Teams (CMHT), outpatient clinics, vol-
untary services (including Manic Depression Fellowship)
and GP practices. Local media and websites are used to
maximize potential referrals from individuals who are not
currently accessing other services. The trial is also sup-
ported by the United Kingdom Mental Health Research
Network (MHRN) who provide Clinical Studies Officers
(CSO) to facilitate recruitment. The research team and
CSOs present verbal and written information outlining
the study to clinicians, health professionals and voluntary
services. Potential participants are offered a participant in-
formation sheet containing an overview of the study by a
member of their care team, or directly by the research
team, if preferred.
Inclusion and exclusion criteria
Participants meeting all of the following criteria will be
included in the study: meet the DSM-IV criteria for
bipolar I or II disorder, or bipolar disorder not-otherwise-
specified, characterized by a past major depressive episode
and DSM-IV hypomania of two days or more; complete a
baseline assessment session in an outpatient setting; have
a baseline score of at least 15 on the Beck Depression
Inventory prior to the study (to ensure presence of sig-
nificant current distress as targeted in the trial) and be
aged 16 years or over.
Participants meeting any of the following criteria will
be excluded from the study: have a diagnosis of a non-
affective psychotic disorder according to the DSM-IV,
currently undergoing mania or a mixed episode according
to the DSM-IV, have a primary substance use disorder ac-
cording to the DSM-IV, have a moderate to severe learn-
ing disability, have an organic impairment that accounts
for their mental health problem or be non-English speak-
ing (owing to the standardized assessment measures).
Figure 1 (CONSORT diagram) provides a summary of
the study procedure. Potential participants are given at
least 24 hours to consider the information provided be-
fore being contacted by a researcher to discuss the study
and ensure that they understand the information pro-
vided. For willing participants, the research team asks
for written permission to contact their GP and/or other
relevant clinician to obtain information that might affect
their ability to take part (risk), and to confirm what clinical
support will be ongoing during the trial. The research
team then conducts a screening assessment to ensure the
participant meets the inclusion criteria for the study. This
screening process can take place over the telephone or
face-to-face (depending on the participantspreference),
and is based on the Brief Screening Interview and two
non-consecutive weeks of exceeding the criteria for de-
pressive symptoms (Beck Depression Inventory >15). If in-
clusion criteria are met at this stage and the potential
participant chooses to enter the trial, full written consent
will be obtained before the initial baseline assessment.
Full assessments will subsequently be conducted on five
occasions: initial baseline, 3 months post-randomization
(mid-treatment for the TEAMS group), 6 months post
randomization (post-treatment for the TEAMS group),
12 months (6 months post-treatment for the TEAMS
group) and 18 months. Those participants who have
met the inclusion criteria following baseline assess-
ment are randomized (to treatment-as-usual or TEAMS
therapy) and informed of their group allocation by letter.
TEAMS treatment usually commences within two weeks
of randomization. See Figure 1 (consort diagram) and
Table 1.
Semi-structured interviews and qualitative analyses
Qualitative data forms a significant part of the study and
will be utilized to guide the subsequent development of
the therapist and client treatment manuals. In this study,
we conduct two semi-structured interviews with a sub-
group of 12 to 15 randomly selected participants. The in-
terviews were informed on the basis of our previous work
on providing TEAMS therapy and through discussions
with an experienced service user who is a co-investigator
for the trial. The first interview is completed at the baseline
Mansell et al. Trials 2014, 15:405 Page 4 of 9
Figure 1 CONSORT diagram showing design of study.
Mansell et al. Trials 2014, 15:405 Page 5 of 9
and explores participantssubjective experiences of how they
have considered, sought and experienced various forms of
treatment in the past, and what they feel an appropriate
psychological treatment should involve.
The second interview occurs within six months of treat-
ment ending and examines participantssubjective experi-
ence of receiving the TEAMS intervention. It focuses on
what might have been beneficial and what was considered
less effective or unhelpful, and eliciting recommendations
for future modifications.
Thematic analysis will be used to analyze qualitative
data. All interviews are audio recorded and transcribed
verbatim. Each transcript will be read and subjected to
content analysis to identify themes. Emerging themes
from each report will be discussed with the research team
to ensure agreement. Data saturation will be regarded as
achieved when no new themes emerge (it is likely that this
will be achieved with approximately 12 to 15 interviews).
Also, a selection of 5 to 10 service providers will be inter-
viewed during the study on their perceptions on their de-
sired outcomes, including referral and retention.
Data monitoring and management
Hard copies of anonymized data are stored at the NHS
site in locked filing cabinets separate from identifiable
information (names, addresses and dates of birth). Raters
enter data into an electronic database that is stored an-
onymously with the participant ID only, in a password-
protected hard drive. All data entry is checked by a second
person and any errors corrected. Only researchers, thera-
pists, study administrators and lead investigators (ST and
WM) have access to personal information. Only the lead
investigators, trial statistician (GD) and researchers have
access to the final dataset.
Adverse and serious adverse events are collected by the
research team and reported to the Chief Investigator or
their nominated deputy. There is no data monitoring com-
mittee because the nature of the intervention is unlikely to
result in any adverse events and there are no interim ana-
lyses or stopping rules for the trial. Trial conduct may be
audited independently of the research team by the sponsor
or independently of both the sponsor and the investigators
by the funders. In the unlikely event of harm, participants
Table 1 Summary of the measures taken at each assessment session and during therapy
Assessment Baseline 3 month
6 month
12 month
18 month
Primary outcome measures
Beck Depression Inventory (BDI) * * * * *
Secondary outcome measures
Structured Clinical Interview for DSM-IV: Axis I (SCID-I) *
Structured Clinical Interview for DSM-IV: Axis II (SCID-II) *
Time to bipolar relapse: weekly LIFE scores (SCID life) * * * * *
Hamilton Depression Rating Scale (HDRS) * * * * *
Bech-Rafaelsen Mania Scale (MAS) * * * * *
Use of services interview for economic analysis * * * * *
EuroQol Health Status Measure (EQ-5D) * * * * *
Stephenson Medication Adherence Interview (SMAI) * * * * *
HAPPI-R (Hypomanic Attitudes and Positive Predictions) Inventory) * * * * *
GAD-7 (Generalized Anxiety Disorder - 7 Scale) * * * * *
Internal States Scale (ISS) * * * * *
Questionnaire about the Process of Recovery (QPR) * * * * *
Qualitative measures
Patient Experience Interview (PEI; Subgroup) *
Sessional therapy measures
Internal States Scale (ISS) graded
Client HAPPI (tailored and reduced to around 15 items)
Therapy satisfaction rating
T-TAC TEAMS therapist adherence checklist
CTS-Rcognitive therapy scale revised
indicates a self-report measure. All other measures are administered by a researcher as a clinical interview.
Pre-sessional client measures.
Post-session client
Adherence measures. Sessional therapy measures are taken at every assessment.
Mansell et al. Trials 2014, 15:405 Page 6 of 9
would have access to compensation through the NHS in-
demnity scheme and through the sponsor of the study.
Statistical analyses
All primary analyses will be based on an intention-to-
treat principle, focusing more on descriptive statistics
and confidence interval estimation than statistical sig-
nificance. Primary and secondary outcomes will be ana-
lyzed employing analysis of repeated measures with a
mixed-effects model, accounting for the discrete timing
of follow-up assessments, and the random censoring in-
troduced by shorter follow-up periods for participants
recruited towards the end of the trial. The sensitivities of
all treatment effect estimates to missing outcome data
arising from patient dropout (non-compliance) will be
examined and secondary analyses carried out to estimate
the Complier-average causal effect (CACE), allowing for
missing outcome data, as described in detail [44,45],
again concentrating on confidence interval estimation
rather than statistical significance. Basic service data for
those refusing randomization will be collected to assess
generalizability of the estimated treatment and economic
effects. Other than the CACE analyses, there will be no
subgroup analysis, interim analysis nor stopping guide-
lines because there are no circumstances under which
the trial would be stopped.
Cost-effectiveness analysis
The incremental cost-effectiveness ratio of TEAMS ther-
apy will be estimated and cost-effectiveness acceptability
analysis conducted, from the perspectives of health and
social care providers and patients - the key stakeholders
in treatment decisions. Case note review and patient ser-
vice use questionnaires are being used to collect data
about formal and informal service use for each participant
to estimate costs for the three months prior to entry to
the study and from study entry to end of follow-up. The
main measure of health benefit is the quality-adjusted life
year, estimated from survival, and the health status of each
patient, measured by the EuroQol. Secondary analyses will
be used to explore uncertainty due to design decisions
and inform the design of a definitive trial.
Dissemination plans
The findings will be disseminated within peer-reviewed
journals authored by the investigators, in addition to
presentations at national and international practitioner
conferences, and workshops delivered to health profes-
sionals as part of training in the TEAMS approach.
This study has been designed to assess the feasibility and
acceptability of TEAMS therapy for bipolar disorder and to
estimate its effect size ahead of a multi-center randomized
controlled trial. TEAMS is based on an integrative cogni-
tive model of bipolar disorder that converges existing the-
oretical approaches and service-user experiences. Whilst
we have established a strong evidence base for several
components of the model, the impact of the intervention
has been based on case studies and a case series to date.
A key strength of the study is its focus on specific
needs and problems as identified by participants. This
psychological intervention aims to address the huge im-
pact of current symptoms (including depression, anxiety,
irritability and hypomania) and functioning (including
life goals around work and social life) that are less em-
phasized within relapse prevention approaches. The im-
portance of this focus is reflected in the evidence for
pervasive subsyndromal symptoms and through the am-
bivalence reported by many recoveredpeople with bi-
polar disorder as to whether their current wellbeing is
satisfactory or complete, given the symptoms and diffi-
culties with functioning they still experience. The im-
portance of focusing treatment on current experiences
converges with our model, which suggests that internal
states during remission are on a continuum with those
in episodes. Therapist and patient develop a shared un-
derstanding of the processes that may contribute to the
maintenance and escalation of these states and are en-
couraged to broaden their bandwidthof tolerance for
such states. This involves understanding, facing, tolerat-
ing, enduring and even utilizing internal states (such as
fear, anger, excitability, happiness, sadness or tiredness)
rather than struggling to suppress or manipulate them.
While this therapeutic process often involves accessing
past memories of these states and preparing for future
situations within which they may arise, the focus is on
their experience in the present and how this is managed.
The design of the study incorporates a number of add-
itional strengths, including multiple longitudinal assessment
points, which at the developmental stage of a treatment
provides important information regarding therapeutic
change. Also, researcher-blinded assessments, session-by-
session process and adherence measures, and a qualitative
analysis of participantsexperiences of treatment as a
whole, and TEAMS specifically, should help ensure that
the quality of the therapy is carefully considered and that
it is modified and enhanced where necessary for future
trials and implementations of TEAMS. The model
would predict that TEAMS plus treatment-as-usual would
lead to reductions in extreme appraisals of internal states
compared to treatment-as-usual and that, in turn, this
cognitive style post-treatment (six month post-baseline),
will be correlated with bipolar symptoms at 12 and
18 months when controlling for other demographic and
clinical factors.
There are a number of limitations of the study. The
clearest of these is that there is no active psychological
Mansell et al. Trials 2014, 15:405 Page 7 of 9
intervention of equal intensity in the control group. At this
stage of treatment development, it is first important to es-
tablish superiority to treatment-as-usual, especially as this
patient group is rarely offered such an intervention in rou-
tine clinical practice. However, especially given recent de-
velopments for bipolar disorder within the Improving
Access to Psychological Therapies system, it will be in-
creasingly important to compare TEAMS with an alterna-
tive psychological approach. There are many potential
active ingredients within TEAMS, including a variety of
strategies and techniques, and so this study will not be able
to identify the necessary, or most efficient, components.
Nevertheless, we will draw upon the TEAMS interview for
feedback from participants. Furthermore, participants have
consented to recording their sessions for later analysis and
so a potential focus of future research is to analyze sessions
to identify the components that precede sudden gains in
symptoms and functioning.
The study follows up on participants no longer than
18 months post-randomization. Given the scope of the
study, this was felt to be appropriate, but longer follow-
ups are essential to confirm the efficacy of an intervention
for a mental health condition that can involve recurrent
relapse. The study is also limited in that it is focused on
one regional area, and utilizes only five clinically qualified
clinical psychologists and/or CBT therapists who engage
in weekly supervision with the developers of the therapy
model. Thus, the potential for disseminating TEAMS to
other groups, regions and health professionals requires
further exploration. TEAMS also has the capacity to be
applied to problematic mood swings outside the context
of bipolar disorder (such as personality disorder or schi-
zoaffective disorder), yet this was not explored in the
current study.
In summary, this protocol is appropriately designed to
establish the feasibility, acceptability and initial effect
sizes ahead of a multi-center trial with a larger number
of participants, therapists and a longer follow-up period.
The provision of adherence and process measures and
participant interviews will provide additional informa-
tion and allow convergence with the burgeoning empir-
ical literature regarding the TEAMS model of bipolar
Trial status
Participants are being recruited into the trial. Treatment
started February 2012 and expected to finish December
CACE: Complier-average causal effect; CBT: Cognitive behaviour therapy;
CSO: Clinical studies officers who help to publicize and recruit to studies like
this registered with the MHRN; CTS-R: Cognitive Therapy Rating Scale;
EQ-5D: EuroQol 5 Dimension; GAD-7: Generalized Anxiety Disorder scale 7
item; HAPPI: Hypomanic Attitudes and Positive Predictions Inventory;
ISS: Internal States Scale; MHRN: Mental Health Research Network, a national
government funded network to support research studies in mental health
registered with the national portfolio in United Kingdom; NHS: National
Health Service, United Kingdom; QPR: Process of Recovery Questionnaire;
T-TAC: TEAMS Treatment Adherence Checklist; TEAMS: Think Effectively
About Mood Swings.
Competing interests
The authors declare that they have no competing interests.
WM and ST conceived of the trial, led the design and contributed to the
writing of the report. SA, AC and HL led the writing of the report. LD led the
economic design and GD led the statistical design for the trial. NT provided
service-user input into trial design. RM provided and led the diagnostic
components of the trial and AM provided guidance for the design of
the trial from its inception. All authors have read and approved the final
version of this manuscript.
This article presents independent research funded by the National Institute
for Health Research (NIHR) under its Research for Patient Benefit (RfPB)
Programme (Grant Reference Number PB-PG-0110-21087). Additional support
costs and infrastructure were provided by Greater Manchester West Mental
Health NHS Foundation Trust. Philip Brawn, Ruth Searson, and Robert Griffiths
provided therapy and clinical supervision for the trial. Professor Morrisss
research time is funded by the National Institute of Health Research (NIHR)
Collaboration for Leadership in Applied Health Research and Care (CLAHRC)
East Midlands. The views expressed are those of the author(s) and not
necessarily those of the NHS, the NIHR or the Department of Health.
The trial sponsor is the University of Manchester and the contact is Lynn
MacRae, Faculty Research Practice Coordinator, FMHS Research Office, 3.53
Simon Building, University of Manchester, Manchester, M15 6FH, United
Kingdom, email:; telephone: 0161 275
5436. Neither the study sponsor or funders had any role in the study design,
the collection, management, analysis and interpretation of the data, writing
of the report and the decision to submit the report for publication, nor did
they have any ultimate authority over these decisions.
Author details
School of Psychological Sciences, University of Manchester, Oxford Road,
Manchester M13 9PL, UK.
The Psychosis Research Unit, GMW Mental Health
NHS Foundation Trust, Harrop House, Bury New Road, Prestwich, Manchester
M25 3BL, UK.
Centre for Biostatistics, Institute of Population Health, Jean
McFarlane Building (1st Floor), Oxford Road, Manchester M13 9PL, UK.
Centre for Health Economics, Institute of Population Health, Jean McFarlane
Building (1st Floor), Oxford Road, Manchester M13 9PL, UK.
Institute of
Mental Health, School of Medicine, University of Nottingham, Wollaton Road,
NG8 1BB, Nottingham, UK.
Bipolar UK, 11 Belgrave Road, London SW1V 1RB,
Received: 15 August 2014 Accepted: 8 October 2014
Published: 24 October 2014
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Cite this article as: Mansell et al.:A novel cognitive behaviour therapy
for bipolar disorders (Think Effectively About Mood Swings or TEAMS):
study protocol for a randomized controlled trial. Trials 2014 15:405.
Mansell et al. Trials 2014, 15:405 Page 9 of 9
... The new framework is informed by the principles of Perceptual Control Theory (PCT) (Powers, 1973), a transdiagnostic framework for understanding psychological wellbeing and distress Alsawy et al., 2014). PCT has already been applied with good effect to various areas of mental health, including psychosis, bipolar disorder, and phobias (Mansell, 2007;Mansell et al., 2014;Healey et al., 2017;Morris et al., 2018;Griffiths et al., 2019a,b). Studies on these mental health problems have supported hypotheses guided by PCT, that loss of control and goal conflict increase individuals' distress. ...
... Therefore, it is more similar to MI-SI, another brief less structured intervention which only requires one or two sessions (Britton et al., 2012). However, MOL has the advantage over MI-SI of having a more in-depth transdiagnostic theoretical basis which has been tested in other clinical populations (Kelly et al., 2011a;Mansell et al., 2014;Healey et al., 2017). Kovacs and Beck's internal struggle hypothesis (Kovacs and Beck, 1977), which is the theoretical basis for MI-SI, posits that individuals attempt suicide when their wish to die is greater than their wish to live. ...
Full-text available
Objectives This paper aims to identify potential areas for refinement in existing theoretical models of suicide, and introduce a new integrative theoretical framework for understanding suicide, that could inform such refinements. Methods Literature on existing theoretical models of suicide and how they contribute to understanding psychological processes involved in suicide was evaluated in a narrative review. This involved identifying psychological processes associated with suicide. Current understanding of these processes is discussed, and suggestions for integration of the existing literature are offered. Results Existing approaches to understanding suicide have advanced the current knowledge of suicide in various ways. They have guided valuable research in the following areas: motivations for suicide and the psychological distress which influences suicide attempts; ambivalence about suicide; suicidal individuals’ focus of attention; and ways in which individuals who contemplate suicide differ from individuals who attempt suicide. We outline a new theoretical framework as a means to integrating all of these concepts into the three principles of control, conflict, and awareness. Within this framework, suicide is regarded as occurring due to a long standing conflict between an individual’s personal goals, culminating in an episode of acute loss of control. The new framework posits that the individual then strives to regain control through the means of suicide because of a narrowed awareness of consequences of their actions on other valued goals. This psychological mechanism of limited awareness is posited to be the common pathway by which individuals make a suicide attempt, regardless of which risk factors are present. Conclusion This article introduces a theoretical framework that generates several hypotheses for future research, and focuses on psychological processes occurring during immediate crisis. One of the key hypotheses resulting from our predictions on how individuals progress from contemplating to attempting suicide will be tested in an ongoing program of research: Individuals who attempt suicide have a significantly reduced awareness of consequences of suicide, which would negatively impact on their important life goals, values, principles, or ideals, compared to individuals who contemplate suicide. Therapy guided by the new framework may be more flexible, immediate, and client-focused than other therapies for suicidal individuals.
... Improving coping strategies is a key facet of relapse prevention (Morriss et al., 2007). However, while avoiding future relapse is important, current difficulties, and not just episodes of hypomania and depression, should be acknowledged in therapy (Mansell et al., 2014), and improving ER and tolerance of emotions is a potentially useful mechanism in therapy (as demonstrated in a transdiagnostic sample; Berking et al., 2008). ...
... Instead, clinicians should work with the client to develop and test working hypotheses around the cost and benefits of the ER strategies they use in particular context, in order to help them to meaningfully change their response. This could be achieved through cognitive behavioural therapy (CBT; Mansell et al., 2014), functional analysis, or Dialectical Behavior Therapy (DBT; Linehan, 1987) ...
Background: Theoretical frameworks emphasise associations between interpretations and responses to affect and bipolar disorder (BD). This review (PROSPERO CRD42016043801) investigated which emotion regulation (ER) strategies have been applied to BD, are elevated in BD compared to clinical and non-clinical controls, and are associated with clinical and functional outcomes in BD Methods: Search terms relating to emotion regulation, coping and bipolar disorder were entered into Embase, MedLine and PsycInfo. Quantitative studies investigating relationships between ER strategies and BD were eligible for this narrative synthesis Results: A large volume of research (n = 47) investigated specific ER strategies in BD. Maladaptive strategies such as rumination and dampening were elevated in BD compared to controls and these particular strategies had a detrimental impact on outcomes such as mood symptoms. BD had a similar profile of ER strategies to unipolar depression, but there was limited comparison to other clinical groups. People with BD did not generally have deficits in using adaptive strategies, as evidenced by comparisons with controls and experimental studies Limitations: Methodological heterogeneity and a lack of ecologically valid ER assessments Conclusions: Empirical literature is critiqued in line with contemporary theories of BD and of emotion regulation more generally, in order to inform future research recommendations. This includes investigation of the importance of context in the impact of ER strategies, and discrepancies between trait and state use of ER strategies, particularly through experience sampling.
... 1. Para trastornos bipolares, el modelo TEAMS (Think Effectively About Mood Swings), es un abordaje de base cognitivo-conductual que está orientado al tratamiento de los síntomas que se manifiestan, incluidos hipomanía subclínica, depresión y ansiedad, y promueve la mejoría a largo plazo y prevención de recaídas, desde una perspectiva transtéorica (Mansell et. al, 2014). ...
... All these may have been effective in increasing the social functionality of the patients. Studies showed that psychosocial interventions carried out with the active participation of patients increased the social functioning of patients [43][44][45]. The findings of our study are in line with the literature. ...
Background and purpose: Treatment non-adherence is quite common among patients with bipolar disorder, negatively affects the social functioning of patients and reduces the quality of life. This pilot study aims to measure the effect of treatment adherence training given to patients with bipolar disorder on treatment adherence, social functioning and quality of life. Materials and methods The pilot study was conducted with 40 bipolar disorder patients, 19 in the intervention group and 21 in the control group, using a quasi-experimental research design. The data were collected using the Participant Information Form, Medication Adherence Rating Scale, Social Functioning Scale and Short Form of the World Health Organization Quality of Life Questionnaire. Treatment adherence training was given once a week individually for a total of five sessions. Results There was no significant difference between the demographic characteristics and pre-test scale scores of the patients in the intervention and control groups before the treatment adherence training (p > 0.05). The mean treatment adherence, social functioning and quality of life scores of the patients in the intervention group were higher in the post-test and follow-up test compared to the patients in the control group (p < 0.001). Conclusion The intervention had a positive effect on treatment adherence, social functioning and quality of life of patients. Considering the promising results of this pilot study, treatment adherence training should be studied further in the patients with biplor disorder.
... The Bipolar at Risk Trial (BART; ISRCTN10773067) was a feasibility randomized controlled trial testing the acceptability of CBT BAR , a 25 session CBT treatment focusing on appraisals of low and high moods for participants fitting the BAR criteria. CBT BAR is developed from the Think Effectively About Mood Swings (TEAMS) CBT approach (Mansell et al., 2014), based on an Integrative Cognitive Model (ICM) (Mansell, Morrison, Reid, Lowens, & Tai, 2007). This ICM proposes that people hold extreme and contradictory appraisals about internal states leading to recurrent styles of thinking, behaving, and feeling that maintain and escalate mood episodes. ...
Full-text available
Objectives: The Bipolar at Risk Trial (BART) was a feasibility randomized controlled trial investigating cognitive behavioral therapy (CBT) compared with treatment as usual (TAU) in young people at high risk of developing bipolar disorder (BD). This qualitative study aimed to investigate participants' experiences of trial involvement, and the acceptability of CBT for this population. Design: Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history. A purposive sample of twenty-one participants from both the intervention and TAU arms of the trial was recruited. Methods: Twenty-one semi-structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU). Interviews were audio recorded with consent from participants and transcribed verbatim. NVivo 11 Pro software was used to conduct an inductive thematic analysis. Results: Super-ordinate themes were "adaptability and flexibility," "feeling understood and valued," and "relevance of study and intervention" which had two sub-themes-"value of the trial therapy" and "acceptability of trial processes." Participating in the trial and having therapy enabled participants to feel understood and valued by research assistants (RAs) and therapists. Participants viewed therapy as relevant to their current concerns and valued adaptability and flexibility of RAs and therapists. Conclusions: Findings highlight the importance and value of flexibility, adaptability, and understanding in relationships between participants and trial staff. Findings also indicate that the trial processes and CBT focusing on mood swings are acceptable and relevant to participants from this at risk population. Practitioner points: Young people at risk of bipolar disorder value a flexible approach to assessments and therapy, developing a rapport with research assistants and therapists and opening up to them when they feel comfortable to do so. CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant.
... All these may have been effective in increasing the social functionality of the patients. Studies showed that psychosocial interventions carried out with the active participation of patients increased the social functioning of patients [43][44][45]. The findings of our study are in line with the literature. ...
Psychoeducation offers a holistic approach that focuses on the philosophy of health, cooperation, coping and empowerment, but it is known that experimental studies used in psychoeducation in schizophrenia are insufficient. The study was conducted with 42 schizophrenia patients using a quasi-experimental research design. Patients were evaluated using a pretest, post-test, follow-up test, “Medication Adherence Rating Scale”, “Quality of Life Scale for Schizophrenia” and “Flourishing Scale". There was a significant difference between the experimental group and the control group in terms of pretest and post-test, pretest and follow-up test scores (p < 0.05). The post-test and follow-up test scores of the patients in the experimental group were determined to increase their quality of life and well-being score (p < 0.05). This study is an important contribution to the literature due to its assessment of the relationship between psychoeducation and change in treatment adherence, quality of life and levels of well-being.
... The current study is a secondary analysis of baseline data from the 'Think Effectively About Mood Swings' (TEAMS; Mansell et al., 2014) randomized control trial. Participants with a DSM-IV diagnosis of bipolar I or II disorder were recruited from NHS Trusts in the North West of England. ...
Background It is important to understand the factors associated with more severe mood symptoms in bipolar disorder. The integrative cognitive model of bipolar disorder proposes that extreme appraisals of changes to internal states maintain and exacerbate mood symptoms. Aims The current study aimed to investigate if post-traumatic stress disorder (PTSD) is related to current depressive and manic bipolar symptoms, and whether this relationship is mediated by appraisals of internal state. Method Participants with bipolar disorder ( n = 82) from a randomized controlled trial of cognitive therapy for bipolar disorder (the TEAMS trial) completed self-reported questionnaires assessing appraisals of internal state, generalized anxiety symptoms, and self-reported and observer-rated depressive and manic symptoms. Clinical interviews assessed PTSD co-morbidity. Results Participants with bipolar and co-morbid PTSD ( n = 27) had higher depressive symptoms and more conflicting appraisals than those without PTSD. Regression analyses found PTSD to be associated with depressive symptoms but not manic symptoms. Conflicting appraisals were found to be associated only with manic symptoms meaning that the planned mediation analysis could not be completed. Conclusions Findings provide partial support for the integrative cognitive model of bipolar disorder and highlight the need for transdiagnostic treatments in bipolar disorder due to the prevalence and impact of trauma and co-morbidity. Working on trauma experiences in therapy may impact on depressive symptoms for those with bipolar disorder and co-morbid PTSD.
... Established psychological therapies for BD, including cognitive behavioural therapy, focus upon ameliorating depression or preventing major relapse [11], not upon addressing mood instability, which is typically not even measured in trials of these therapies. A small number of published studies have investigated psychological therapies for cyclothymic disorder [12][13][14] or have considered mood instability within a psychological approach for individuals with BD [15,16]; however, none have selected those with BPMI across the bipolar spectrum and tested an intervention that directly targets this aspect. Consequently, we sought to develop an intervention that addresses mood instability in all of those with a bipolar spectrum condition who view this part of their condition as a primary problem. ...
Full-text available
Background: In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-informed approach (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). It seeks to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Methods/design: Patients will be randomised 1:1 to either treatment as usual only (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points will be at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point for the candidate primary outcome measures. We aim to recruit 48 individuals meeting diagnostic criteria for a bipolar spectrum disorder and reporting frequent mood swings outside of acute episodes, through primary and secondary care services and self-referral. To evaluate feasibility and acceptability, we will examine recruitment and retention rates, completion rates for study measures and feedback from participants on their experience of study participation and therapy. Discussion: Proceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment. Trial registration: ISRCTN, ISRCTN54234300 . Registered on 20 July 2017.
... It places a heavy burden on sufferers and families, and has high societal and healthcare costs [1,2]. An estimated 2 to 6% of the general population in the UK meet the criteria for bipolar disorder, costing £5.2 billion annually in healthcare and lost employment [3]. Many of the service users with a diagnosis of bipolar disorder also experience prominent psychotic symptoms, with differential diagnoses of schizoaffective disorder, and relapses characterised by repeated manic psychotic episodes and grandiosity. ...
Full-text available
Background Bipolar disorder is a chronic and disabling psychiatric condition, characterised by recurrent episodes of mania, hypomania and depression. It places a heavy burden on sufferers and families, with high societal and healthcare costs. Many service users with a diagnosis of bipolar disorder also experience prominent psychotic symptoms, with differential diagnoses of schizoaffective disorder, and relapses characterised by repeated manic psychotic episodes and grandiosity. Such presentations require specific adaptations to standard bipolar disorder interventions in order to address their psychosis, alongside mood regulation, with a particular emphasis on impulsivity, irritability, disinhibition and elation. The Balancing ACT study aims to evaluate an innovative group intervention combining Acceptance and Commitment Therapy and psychoeducation approaches (ACT/PE) with individuals experiencing bipolar disorder and/or symptoms within community psychosis services. Methods The Balancing ACT study is a randomised controlled trial comparing Balancing ACT groups (ACT/PE) plus routine care to routine care alone. Balancing ACT (ACT/PE) comprises ten group sessions, each lasting 2 hours, delivered weekly. The primary outcome is psychological wellbeing; secondary outcomes are mental health relapses (measured by service use averages for the 12 months pre baseline and 3 months post baseline). We will also measure mood, distress, recovery and psychological change processes. Participants will be randomised in a 1:1 ratio, after baseline assessment. Outcomes will be assessed by trained assessors blind to treatment condition at 0, 10 and 14 weeks. Recruitment began in April 2017 and is on-going until the end of October 2017. Discussion The Balancing ACT study will contribute to the currently limited evidence base for psychological interventions for people experiencing bipolar disorder and/or symptoms in the context of community psychosis services. Trial registration ISRCTN73327972. Registered on 27 March 2017. Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder.
The main aim of this research was to investigate the effect of the 8-week group therapy intervention based on the integrative cognitive model (ICM) of bipolar disorder. The sample was composed of 10 patients with bipolar I and bipolar II diagnoses. The group sessions were held once a week for 1.5 hours. For the quantitative measures, the group participants were assessed during pre-test, post-test and 3-month follow-up using the Turkish versions of the Beck Depression Inventory, the Hypomanic Attitudes and Positive Predictions Inventory, the Psychological Well-being Scale and the Satisfaction with Life Scale. Quantitative analyses revealed that a reliable change was seen only in pre-test and post-test depression scores. However, this change could not be maintained at 3-month follow-up. For the qualitative analyses, data collected during semi-structured interviews were used. The thematic analyses results showed that the 8-week ICM-based group therapy was found to help participants make sound observations about their behaviors, decrease their feelings of loneliness and increase self-acceptance, and acceptance of the role of mood swings in their lives. Moreover, the results showed that participants found the following activities very beneficial: describing their emotions, evaluating the intensity of their emotions, identifying their life goals, coping with interpersonal conflicts, evaluating resources and going over strengths. In conclusion, the 8-week ICM-based group therapy had a positive impact on participants’ self-awareness, self-acceptance and self-perception. Key learning aims (1) To learn more about the integrative cognitive model and how it has been reconceptualized for group-based intervention. (2) To understand the structure and content of group CBT protocol for bipolar disorders based on the integrative cognitive model. (3) To consider possible advantages of group CBT for bipolar disorders during the recovery process.
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Posttraumatic stress disorder (PTSD) is a common reaction to traumatic events. Many people recover in the ensuing months, but in a significant subgroup the symptoms persist, often for years. A cognitive model of persistence of PTSD is proposed. It is suggested that PTSD becomes persistent when individuals process the trauma in a way that leads to a sense of serious, current threat. The sense of threat arises as a consequence of: (1) excessively negative appraisals of the trauma and/or ist sequelae and (2) a disturbance of autobiographical memory characterised by poor elaboration and contextualisation, strong associative memory and strong perceptual priming. Change in the negative appraisals and the trauma memory are prevented by a series of problematic behavioural and cognitive strategies. The model is consistent with the main clinical features of PTSD, helps explain several apparently puzzling phenomena and provides a framework for treatment by identifying three key targets for change. Recent studies provided preliminary support for several aspects of the model.
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This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2013, Issue 12 Buprenorphine for treating cancer pain (Protocol)
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The existing scale for assessing competence in cognitive therapy (CTS) dates from 1988 and only the previous version of 1980 has been validated to any extent. A revised version, the CTS-R, was devised to improve on the CTS by: eliminating overlap between items, improving on the scaling system, and defining items more clearly. Kolb's well-known educational model was used as a guideline. In the new 14-item scale, three new items measure general therapeutic flair, the facilitation of emotional expression, and therapist's non-verbal behaviours (optional). We hypothesized that the CTS-R would prove more user friendly and demonstrate satisfactory reliability and validity. Twenty-one mental health professionals undergoing training in cognitive therapy provided 102 video-tapes of therapy with 34 patients, reflecting three stages of therapy. The tapes were rated by four expert raters, in a balanced design. The CTS-R showed high internal consistency and adequate average inter-rater reliability. Reliability for individual items varied widely among pairs of raters. Validity was demonstrated by improved ratings of competence for trainees who saw patients early and later during the course of training. Although raters found the CTS-R a more useful tool than the CTS and satisfactory reliability and validity were demonstrated, more refinement is needed in item definition. The study has led to modifications in the CTS-R, which are in the process of evaluation.
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Objective: To compare the efficacy of mindfulness-based cognitive therapy (MBCT) plus treatment as usual (TAU) to TAU alone for patients with bipolar disorder over a 12-month follow-up period. Method: Participants with a DSM-IV diagnosis of bipolar disorder were randomly allocated to either MBCT plus TAU or TAU alone. Primary outcome measures were time to recurrence of a DSM-IV major depressive, hypomanic or manic episode; the Montgomery-Åsberg Depression Rating Scale (MADRS); and Young Mania Rating Scale (YMRS). Secondary outcome measures were number of recurrences, the Depression Anxiety Stress Scales (DASS), and the State Trait Anxiety Inventory (STAI). Results: Ninety-five participants with bipolar disorder were recruited to the study (MBCT = 48; TAU = 47). Intention-to-treat (ITT) analysis found no significant differences between the groups on either time to first recurrence of a mood episode or total number of recurrences over the 12-month period. Furthermore, there were no significant between-group differences on the MADRS or YMRS scales. A significant between-group difference was found in STAI - state anxiety scores. There was a significant treatment by time interaction for the DAS - achievement subscale. Conclusion: While MBCT did not lead to significant reductions in time to depressive or hypo/manic relapse, total number of episodes, or mood symptom severity at 12-month follow-up, there was some evidence for an effect on anxiety symptoms. This finding suggests a potential role of MBCT in reducing anxiety comorbid with bipolar disorder.
• We report the reliability and validity of the Internal State Scale, a self-report instrument for the simultaneous assessment of severity of manic and depressive symptoms. The Internal State Scale consists of four empirically derived subscales: Activation, Well-Being, Perceived Conflict, and the Depression Index. All subscales had good internal consistency reliability. Activation subscale scores were significantly higher in manic patients than in depressed patients or control subjects, while Well-Being subscale scores were significantly lower and the Depression Index subscale scores were significantly higher in depressed patients than in the other two groups. Activation subscale scores were correlated specifically with clinician ratings of mania. Depression Index subscale scores were correlated specifically with clinician ratings of depression. Further evidence for the validity of the subscales of the Internal State Scale in reflecting manic or depressive symptoms came from discriminant function analysis in which these subscales assigned 88% of subjects to the correct diagnostic groups. In affectively ill patients who were studied in two or more mood states, Activation, Depression Index, and Well-Being subscale scores changed significantly in the predicted directions, while the same discriminant algorithm assigned 79% of mood states to the correct diagnostic category. Bimodal distribution of scores of manic patients on the Well-Being and Depression Index subscales substantiated earlier findings that euphoric mood is not an essential feature of mania. Based on findings from this and previous studies, the hypothesis is proposed that variables related to activation level, and not to mood state, constitute the core characteristics of the manic syndrome.
The difficulties inherent in obtaining consistent and adequate diagnoses for the purposes of research and therapy have been pointed out by a number of authors. Pasamanick12 in a recent article viewed the low interclinician agreement on diagnosis as an indictment of the present state of psychiatry and called for "the development of objective, measurable and verifiable criteria of classification based not on personal or parochial considerations, but on behavioral and other objectively measurable manifestations."Attempts by other investigators to subject clinical observations and judgments to objective measurement have resulted in a wide variety of psychiatric rating scales.4,15 These have been well summarized in a review article by Lorr11 on "Rating Scales and Check Lists for the Evaluation of Psychopathology." In the area of psychological testing, a variety of paper-and-pencil tests have been devised for the purpose of measuring specific