Clinical trial NCT01981018: MAPP: Imagery-focused Therapy for Bipolar Disorder
Official title: Mood Action Psychology Programme (MAPP): a Case Series Investigation of Brief Imagery-focused Cognitive Therapy (imCT) for Bipolar Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Mental imagery, CBT, anxiety, mood instability
Lead sponsor: Medical Research Council Cognition and Brain Sciences Unit
Sponsor class: OTHER_GOV
Collaborators: name: Cambridgeshire and Peterborough NHS Foundation Trust
name: Oxford Health NHS Foundation Trust
name: University of Cambridge
name: University of Oxford
First posted: 2013-11-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or Female, aged 18 - 65 years old
* Have adequate English language ability to permit the assessment and experimental measures to be completed
* Have diagnosis of Bipolar Disorder (I or II or NOS) according to Diagnostic and Statistical Manual IV-TR (DSM-IV) criteria (American Psychiatric Association, 2000) as indicated by the Structured Clinical Interview for DSM-IV (SCID) (First, Spitzer, M., \& Williams, 2002)
* Are willing to complete daily/weekly mood and anxiety monitoring throughout the duration of the study
* Successfully complete daily monitoring in the 4 weeks active run-in phase
* Are willing to have regular treatment reports and letters sent to their GP and other relevant clinicians
* Can commit to attending 10 consecutive weekly sessions, including questionnaires completion, and follow up period as required by the study
* Are residents within geographical areas covered by the NHS trusts where treatment is delivered

Exclusion Criteria:

* Do not have diagnosis of Bipolar Disorder (I or II or NOS) according to Diagnostic and Statistical Manual IV-TR (DSM-IV) (American Psychiatric Association, 2000) criteria as indicated by the Structured Clinical Interview for DSM-IV (First et al., 2002)
* Learning difficulties, organic brain disease, severe neurological impairment
* Current severe substance or alcohol misuse (clinicians assessment)
* Current manic episode as diagnosed by DSM-IV criteria (American Psychiatric Association, 2000) indicated by the SCID (First et al., 2002)
* Current active psychotic symptoms
* Presence of active suicidal risk as indicated by a score of 2 or more on item 12 of the QIDS (Rush et al., 2003) (i.e. frequent thoughts and/or plans to end their life) confirmed by convergent clinical opinion
* Unwilling to engage actively in treatment or to use an imagery-focussed approach for treatment
* Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for BD

Primary outcomes:
measure: Anxiety and depression scores change
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Imagery Characteristics
timeFrame: 4 weeks
measure: Anxiety and depression change maintenance at follow up
timeFrame: 12 and 24 weeks
measure: Mood instability
timeFrame: 4 weeks and 24 weeks
measure: Depression and mania relapse rate and duration
timeFrame: 24 weeks
measure: Anxiety comorbidity
timeFrame: 24 weeks
measure: Medication compliance
timeFrame: 24 weeks
measure: General functioning and coping
timeFrame: 24 weeks
measure: Suicidality
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: MRC Cognition and Brain Sciences Unit
city: Cambridge
country: United Kingdom
facility: Cambridge and Peterborough NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: University of Oxford, Department of Psychiatry
city: Oxford
country: United Kingdom
facility: Oxford Health NHS Foundation Trust
Study officials:
affiliation: Medical Research Council Cognition and Brain Sciences Unit
name: Emily A Holmes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmes EA, Deeprose C, Fairburn CG, Wallace-Hadrill SM, Bonsall MB, Geddes JR, Goodwin GM. Mood stability versus mood instability in bipolar disorder: a possible role for emotional mental imagery. Behav Res Ther. 2011 Oct;49(10):707-13. doi: 10.1016/j.brat.2011.06.008. Epub 2011 Jul 5.
citation: Bonsall MB, Wallace-Hadrill SM, Geddes JR, Goodwin GM, Holmes EA. Nonlinear time-series approaches in characterizing mood stability and mood instability in bipolar disorder. Proc Biol Sci. 2012 Mar 7;279(1730):916-24. doi: 10.1098/rspb.2011.1246. Epub 2011 Aug 17.
citation: Holmes EA, Geddes JR, Colom F, Goodwin GM. Mental imagery as an emotional amplifier: application to bipolar disorder. Behav Res Ther. 2008 Dec;46(12):1251-8. doi: 10.1016/j.brat.2008.09.005. Epub 2008 Oct 8.
citation: Holmes EA, Bonsall MB, Hales SA, Mitchell H, Renner F, Blackwell SE, Watson P, Goodwin GM, Di Simplicio M. Applications of time-series analysis to mood fluctuations in bipolar disorder to promote treatment innovation: a case series. Transl Psychiatry. 2016 Jan 26;6(1):e720. doi: 10.1038/tp.2015.207.