An interventional study of Imagery-focused Cognitive Therapy (ImCT - psychotherapy based on CBT principles) in Bipolar Disorder, sponsored by Medical Research Council Cognition and Brain Sciences Unit. Completed at 4 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-30.
Sponsored by Medical Research Council Cognition and Brain Sciences Unit · Not applicable, Interventional, and Treatment
Among 45 studies in Bipolar Disorder with a site in United Kingdom — 9 open to participants now, 9 under way, 1 of them phase 3. Bipolar Disorder · United Kingdom.
Among the 45 studies in Bipolar Disorder with a site in United Kingdom, this one is the 22nd largest by planned enrollment of the 30 interventional ones that give a count, is the only one that started in 2013, is one of 17 with no phase, and was the 15th registered.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
Browse Bipolar Disorder studies →9 of the 45 studies in Bipolar Disorder with a site in United Kingdom are open now. Recruiting first, the newest first:
King's College London · Sites in United Kingdom
Ages 18+
King's College London · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
Akrivia Health · Sites in United Kingdom
Ages 18–110
Dr. Inge Winter · Sites in United Kingdom, Austria, Germany and 3 more countries
Ages 18+
Alto Neuroscience · Sites in United Kingdom, United States
Ages 18–70
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 203 Bipolar Disorder studies recruiting now, 59 (29%) set no upper age limit and 132 (65%) stop at 75 or younger; 37 take children under 18; 49 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Median enrollment 51 across the 30 interventional studies, 500 across the 15 observational. Of the 32 that completed or were terminated, 4 (13%) have results posted.
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14 of 45 have an industry lead sponsor. The 10 most frequent:
Medical Research Council Cognition and Brain Sciences Unit is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Medical Research Council Cognition and Brain Sciences Unit has 1 study filed under Bipolar Disorder — fewer than ten, so there is no comparison to draw.
3 of the studies in Bipolar Disorder with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07398365University of EdinburghMedical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients | 2026-12-31 |
| NCT07556692King's College LondonA Study of Home-use Brain Stimulation to Treat Bipolar Depression | 2027-04-30 |
| NCT06656416Alto NeuroscienceALTO-100 in Bipolar Disorder With Depression (BD-D) | 2027-09 |
Among the 45 studies in Bipolar Disorder with a site in United Kingdom, from their registry updates:
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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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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)
Time frame: 4 weeks
Changes in Imagery Characteristics
Imagery characteristics are recorded in order to test if reductions in anxiety and low mood levels over 4 weeks after treatment compared to baseline (i.e. the primary objective) are mediated by reductions in levels of problematic imagery during treatment. This is assessed from recording changes in Visual Analogue Scales of Imagery Characteristics (VAS Imagery) combined ratings pooled from aggregated time points during treatment. Visual Analogue Scales (VAS Imagery) have been tailored to BD population rating on a scale 0-9, for example such as: "How real / vivid / absorbing / preoccupying / compelling have your image(s) been over the past week'"; "To which extent could you understand the role that the image(s) play in your mood instability?"; "To which extent could you find positive / helpful way of using the image(s)?", in line with Brewin (Brewin et al., 2009) and clinical audit results from the OxMAPP clinical psychology service for BD.
Time frame: 4 weeks
Anxiety and depression change maintenance at follow up
Change in scores on measures of (i) BAI (anxiety scale) (ii) QIDS (depression scale) will be pooled from aggregated time points over 12 and 24 weeks during follow up and compared to aggregated time points over baseline.
Time frame: 12 and 24 weeks
Mood instability
Change in mood instability will be calculated as the time series profile of daily mood and anxiety ratings on the QIDS-m scale over 4 weeks, prior and after treatment based on work with Bonsall (Bonsall et al., 2012); convergent change on the self-report proxy measures of mood instability Affective Lability Scale - short version (ALS-18) (Oliver \& Simons, 2004) and Internal States Scale (ISS) (Bauer, Crits-Christoph, et al., 1991) will be collected at 4, 12, and 24 week follow up.
Time frame: 4 weeks and 24 weeks
Depression and mania relapse rate and duration
Reductions in (i) the number of relapses comparing 24 weeks prior to treatment start to 24 weeks following treatment completion: a relapse is counted as a time when a patient has experienced a depressive, (hypo)manic or mixed episode according to Diagnostic and Statistical Manual IV, DSM IV diagnostic criteria counted on the Structured Clinical Interview for DSM IV (SCID); and (ii) the duration of relapses retrospectively assessed via the SCID.
Time frame: 24 weeks
Anxiety comorbidity
Reduction of number of anxiety disorders (categorised according to DSM-IV criteria) present on SCID items F1-24, F66, F67, F25-38, F40-64, F68, from baseline to 4, 12 and 24 weeks after treatment.
Time frame: 24 weeks
Medication compliance
Change in scores on the Medication Compliance Questionnaire (Lam et al., 2003) after treatment and at 4, 12 and 24 week follow up compared to baseline.
Time frame: 24 weeks
General functioning and coping
Change in scores on the Longitudinal Interval Follow up Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT) (Leon et al., 2000; Leon et al., 1999) functioning scale after treatment and at 4, 12 and 24 week follow up compared to baseline; change in scores of the "Mental Imagery and Coping with Bipolar Disorder Questionnaire" after treatment and at 4, 12 and 24 week follow up compared to baseline.
Time frame: 24 weeks
Suicidality
Change in ratings of items related to suicidality on the QIDS and on the Beck Hopelessness Scale (BHS) (Beck \& Steer, 1998) after treatment and at 4, 12 and 24 week follow up compared to baseline.
Time frame: 24 weeks
The record gives a start of Nov 2013, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
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Medical Research Council Cognition and Brain Sciences Unit