MAPP: Imagery-focused Therapy for Bipolar Disorder

NCT01981018 | Completed

• 1 other identifier: MAPP_0174
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Bipolar Disorder

Keywords

Mental imagery, CBT, anxiety, mood instability

Outcome Measures

Primary Outcomes (1)

• Anxiety and depression scores change

  To assess the primary endpoint in the study, i.e the change in scores on measures of (i) Beck Anxiety Inventory (BAI) (Beck \& Steer, 1993) (ii) Quick Inventory of Depressive Symptoms (QIDS) (Rush et al., 2003) after treatment, pooled scores from aggregated time points over 4 weeks after treatment compared to aggregated time points over baseline changes anxiety (BAI) and low mood (QIDS) are used. This method is advised given that traditional self-report mood ratings over a single time point are scarcely representative of mood variability in BD. For this scope the following assessments are repeated weekly for all study duration: * Quick Inventory of Depressive Symptomatology, Self-Report (QIDS) (Rush et al., 2003) * Beck Anxiety Inventory (BAI) (Beck \& Steer, 1993)

  4 weeks

Secondary Outcomes (8)

• Changes in Imagery Characteristics

  4 weeks

• Anxiety and depression change maintenance at follow up

  12 and 24 weeks

• Mood instability

  4 weeks and 24 weeks

• Depression and mania relapse rate and duration

  24 weeks

• Anxiety comorbidity

  24 weeks

Study Arms (1)

Imagery-focused Cognitive Therapy

EXPERIMENTAL

10 sessions of imagery-focused Cognitive Therapy delivered approximately weekly by two co-therapists, divided in 4 assessment, 4 treatment and 4 consolidation sessions; additional 2 "blip" management sessions during therapy and 3 "blip" management and booster session during follow up can be delivered if necessary.

Other: Imagery-focused Cognitive Therapy (ImCT - psychotherapy based on CBT principles)

Interventions

Imagery-focused Cognitive Therapy (ImCT - psychotherapy based on CBT principles) OTHER

ImCT Therapy is carried out by a team of 2 co-therapists and comprises of: * Mapping: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus, with regards to imagery symptoms and anxiety co-morbidity that impact on bipolar mood instability. This leads to an individualised formulation of the patient's current problem. * Target: Follows the rationale, timing and objectives identified collaboratively in Mapping. It is structured around imagery-based techniques, such as imagery rescripting, which are used to address problematic imagery, to promote management of mood and boost self-care. This results into the acquisition of imagery-based mood- and anxiety-regulating strategies to be integrated into the patient's already existing coping strategies. * Consolidation: Consist of fine tuning the strategies devised during Target based on experience gained after testing them out in real life situations and includes a "video blue print.

Imagery-focused Cognitive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Research Council Cognition and Brain Sciences Unit: lead
• Cambridgeshire and Peterborough NHS Foundation Trust: collaborator
• Oxford Health NHS Foundation Trust: collaborator
• University of Cambridge: collaborator
• University of Oxford: collaborator

Study Sites (4)

MRC Cognition and Brain Sciences Unit

Cambridge, CB2 7EF, United Kingdom

Location

Cambridge and Peterborough NHS Foundation Trust

Cambridge, United Kingdom

Location

University of Oxford, Department of Psychiatry

Oxford, Ox3 7JX, United Kingdom

Location

Oxford Health NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 21798515 BACKGROUND

• 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.

  PMID: 21849316 BACKGROUND

• 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.

  PMID: 18990364 BACKGROUND

• 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.

  PMID: 26812041 DERIVED

Related Links

• Mood monitoring website used for the study - password protected access

MeSH Terms

Conditions

Bipolar Disorder; Color Vision Defects; Anxiety Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily A Holmes, PhD

  Medical Research Council Cognition and Brain Sciences Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

GB (4)