Bipolar Disorder Clinical Trial
Official title:
Mood Action Psychology Programme (MAPP): a Case Series Investigation of Brief Imagery-focused Cognitive Therapy (imCT) for Bipolar Disorder.
Bipolar Disorder (BD) (previously known as "manic depression") is a severe mental health
illness affecting at least 1% of the population and with annual NHS cost estimated at £342
million. It is characterised by alternating episodes of acute mood swings: depression and
"mania" (mood elation). BD also comes with less severe mood swings we call "mood
instability", and ongoing high levels of anxiety that impair well-being even during periods
between the acute mood breakdowns. Anxiety and mood instability are associated with worse
outcome of the disorder.
All these symptoms can be accompanied by the presence of troublesome mental images (e.g.
seeing a memory in the mind's eye) such as intrusive "flashbacks" of negative past events.
Recent studies suggest that individuals with BD experience more vivid, compelling and
upsetting mental images compared to other patient groups and this could contribute to their
clinical difficulties.
Cognitive Behavioural Therapy (CBT) is a well established and successful psychological
therapy used in the National Health Service (NHS), UK but as yet with limited efficacy in
BD. Targeting mental imagery has long been part of general CBT. In particular, imagery-based
treatment techniques have proved successful in anxiety disorders, but have not been brought
to CBT for Bipolar Disorder yet.
Our study Mood Action Psychology Programme (MAPP) investigates the delivery of a brief
imagery-focused cognitive therapy (imCT) intervention to people with BD, studying a series
of patients in detail one by one a "case series"). We offer a structured and individualised
psychological treatment in line with the aims of NHS guidelines. The imCT protocol has been
successfully delivered and audited in our psychological service in Oxford (OxMAPP). The
proposed MAPP study aims to formally assess for the first time the effectiveness of imCT. In
particular we hypothesise that imCT via the Mood Action Psychology Programme (MAPP) will
result in (i) reduced levels of anxiety and (ii) reduced levels of low mood after treatment
compared to baseline (both measured over 4 weeks) in individuals with BD.
Overall, this works aims to contribute to improved psychological treatment for BD.
Mood Action Psychology Programme (MAPP) is a study that investigates the delivery of an
imagery-focused cognitive therapy (imCT) intervention to people with Bipolar Disorder (BD)
via a single case series (N = 15) design. MAPP offers patients a structured and
individualised psychological treatment (imCT) for BD inline with the aims of the National
Institute for Clinical Excellence, UK guidelines (NICE, 2006) and as already developed and
audited in the OxMAPP psychological service that was run within the Professorial Mood
Disorders clinic at the Warneford Hospital, Oxford. In addition MAPP aims to improve the
understanding of psychological therapy by formally assessing the effectiveness of imCT in
reducing anxiety and low mood symptoms. Secondary aims are to test the hypothesis that
reductions in anxiety and low mood levels are mediated by changes in problematic imagery
phenomena, and investigating the impact of imCT on interepisodic mood instability, coping
skills and general functioning of patients with BD. The short term (i.e. at 6 month follow
up) effect on preventing relapses of (hypo)manic and depressive episodes is also evaluated.
The rationale for this approach derives from current evidence of (i) the uncertain efficacy
in BD of traditional CBT relying exclusively on verbal thought modification approaches
(Scott et al., 2006), (ii) the presence of dysfunctional mental imagery in BD patients
(Bonsall et al., 2012; Hales et al., 2011; Ivins et al., under review) alongside high rates
of anxiety comorbidity (Simon et al., 2004) and (iii) the success of imagery-based treatment
techniques in anxiety disorders such as PTSD and social phobia (Ehlers & Clark, 2008). A
case-series approach allows flexible and feasible but robust testing of the novel imCT
treatment protocol with the aim of optimising it for further investigation in future
randomised controlled clinical trials.
MAPP provides structured individualised treatment, which includes an extended mapping (i.e.
assessment) phase for patients with BD based on cognitive behavioural principles. Where
appropriate, MAPP offers a brief cognitive therapy intervention drawing on mental imagery
(imCT). It includes a focus on addressing anxiety symptoms that are often present and
problematic in BD. The patients and clinician jointly identify an agreed treatment target
(e.g. trauma memories, social anxiety, intrusive imagery) which is hypothesised to have
impact on the mood stability of patients. The agreed treatment target is one which is judged
to be tractable and amenable to change in a brief intervention using imagery focused
techniques.
Participation in the MAPP study is suitable for outpatients with a diagnosis of BD who would
like to gain a better understanding of their symptoms, are interested in adding a
psychological approach to their mood management, and are happy to take part in clinical
research. The programme involves weekly symptom monitoring, as well as committing to weekly
therapy sessions (10 sessions), and is suitable for patients who are agreeable to both of
these. Treatment is offered to patients who comply with the daily mood monitoring active run
in phase. Referrals of young patients (18-25 years old) are encouraged, given evidence that
psychological treatment might be more effective at the onset of BD, in particular when
targeting anxiety and mood instability. Within MAPP, psychological treatment is delivered by
a team of therapists. The therapists are clinical psychologists and psychiatrists with
specific imCT training. Typically two co-therapists are present in each session, one of
which can attend the session also via Skype. MAPP is integrated in psychiatric secondary
care within two NHS trusts, the Cambridge and Peterborough Foundation NHS Trust and the
Oxford Health NHS Foundation Trust. In both NHS trusts imCT is given alongside psychiatric
medication as usual. Patients enrolled in the study maintain their ongoing contact with
other core clinical services.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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