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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
1
, Sara Tai
1
, Alexandra Clark
2
, Savas Akgonul
2
, Graham Dunn
1
, Linda Davies
4
, Heather Law
3
,
Richard Morriss
2*
, Neil Tinning
5
and Anthony P Morrison
6
Abstract
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: richard.morriss@nottingham.ac.uk
2
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
TRIALS
© 2014 Mansell et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
Mansell et al. Trials 2014, 15:405
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Background
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.
Method
The study was approved by the London Queens-Square
Research Ethics Committee (REC reference: 11/LO/1326).
Objectives
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
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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
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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]).
Recruitment
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).
Procedure
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
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Figure 1 CONSORT diagram showing design of study.
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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
follow-up
6 month
follow-up
12 month
follow-up
18 month
follow-up
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
1
Internal States Scale (ISS) graded
1
Client HAPPI (tailored and reduced to around 15 items)
2
Therapy satisfaction rating
3
T-TAC TEAMS therapist adherence checklist
3
CTS-Rcognitive therapy scale revised
indicates a self-report measure. All other measures are administered by a researcher as a clinical interview.
1
Pre-sessional client measures.
2
Post-session client
measures.
3
Adherence measures. Sessional therapy measures are taken at every assessment.
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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.
Discussion
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
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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
disorder.
Trial status
Participants are being recruited into the trial. Treatment
started February 2012 and expected to finish December
2014.
Abbreviations
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.
Authorscontributions
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.
Acknowledgements
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: Lynne.k.macrae@manchester.ac.uk; 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
1
School of Psychological Sciences, University of Manchester, Oxford Road,
Manchester M13 9PL, UK.
2
The Psychosis Research Unit, GMW Mental Health
NHS Foundation Trust, Harrop House, Bury New Road, Prestwich, Manchester
M25 3BL, UK.
3
Centre for Biostatistics, Institute of Population Health, Jean
McFarlane Building (1st Floor), Oxford Road, Manchester M13 9PL, UK.
4
Centre for Health Economics, Institute of Population Health, Jean McFarlane
Building (1st Floor), Oxford Road, Manchester M13 9PL, UK.
5
Institute of
Mental Health, School of Medicine, University of Nottingham, Wollaton Road,
NG8 1BB, Nottingham, UK.
6
Bipolar UK, 11 Belgrave Road, London SW1V 1RB,
UK.
Received: 15 August 2014 Accepted: 8 October 2014
Published: 24 October 2014
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doi:10.1186/1745-6215-15-405
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
http://www.trialsjournal.com/content/15/1/405
... 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. ...
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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.
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