CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB
Study Details
Study Description
Brief Summary
The goal of this case series is to explore whether a talking therapy, specifically Cognitive Behavioural Therapy (CBT) is acceptable and feasible in the management of mood-driven impulsive behaviours in people with bipolar disorder (BD).
The main questions it aims to answer are:
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Whether CBT Is a feasible intervention for participants with BD who report mood-driven, problematic impulsive behaviours.
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Whether CBT for mood-driven, problematic impulsive behaviours (CBT-PIB) is acceptable to service users with BD and therapists.
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Whether clinical outcomes are consistent with the potential for this novel intervention to offer clinical benefit to participants with BD.
The study also hopes to:
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conduct a preliminary examination of the safety of CBT-PIB and the research procedures.
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gather information on the potential mechanisms of action of CBT-PIB and,
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gather information on the types of mood-driven impulsive behaviours individuals with BD may seek support for.
Participants will:
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be offered up to 12 individual sessions of CBT focusing on mood-driven impulsive behaviours.
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be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment.
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be asked to track mood and impulsive behaviours by completing a brief set of measures (3) weekly during the two-week baseline phase, the intervention phase and the 2-week post-intervention phase.
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be asked to complete a survey on the acceptability of the intervention and
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be invited to an optional semi-structured interview on their research experience.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT for mood driven, problematic, impulsive behaviours All participants will be offered the 12 week CBT intervention |
Behavioral: Cognitive Behavioural Therapy for Problematic Impulsive Behaviours
Up to 12 sessions of Cognitive Behavioural Therapy adapted to focus on mood-driven impulsivity in adults with bipolar disorder.
|
Outcome Measures
Primary Outcome Measures
- Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB [Post-intervention at week 16]
qualitative and quantitative feedback from participants
- rates of clinically significant and reliable change in mood measured by the Patient health questionnaire (PHQ-9) [Through study completion, an average of 18 weeks]
used to monitor the severity of depression and response to treatment
- rates of clinically significant and reliable change in symptoms of mania measured by the Altman Self-Rating Mania Scale [Through study completion, an average of 18 weeks]
scale that assesses the presence and severity of manic or hypomanic symptoms
- Changes in management of impulsivity measured by the Visual Analogue Scale [Through study completion, an average of 18 weeks]
Visual scale measuring the severity and impact of general and behavioural impulsivity
- Number of participants with intervention-related adverse events assessed by the adverse events form [Through study completion, an average of 18 weeks]
qualitative form eliciting adverse events
Secondary Outcome Measures
- rates of clinically significant and reliable change in general daily functioning as measured by the Work and Social Adjustment Scale [At baseline, 2 weeks and 14 weeks]
scale assesses changes in the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships.
- rates of clinically significant and reliable change in quality of life as measured by the Brief Quality of Life in Bipolar Disorder [At baseline, 2 weeks and 14 weeks]
self-report measure of changes in disorder-specific quality of life
- rates of clinically significant and reliable change in symptoms of anxiety as measured by the General Anxiety Disorder Assessment (GAD7) [At baseline, in 2 weeks and in 14 weeks]
scale measuring changes in symptoms of anxiety
- rates of clinically significant and reliable change in overall wellbeing as measured by the Warwick-Edinburgh Mental Well-being Scale [At baseline, in 2 weeks and in 14 weeks]
scale measuring changes in positive features of mental health
- rates of clinically significant and reliable change in impulsivity measured by the Short Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale [At baseline, in 2 weeks and in 14 weeks]
Scale measuring changes in 5 domains of impulsive behaviour
Eligibility Criteria
Criteria
Inclusion Criteria:
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meeting diagnostic criteria for Bipolar I or II Disorder (SCID-5- Structured clinical interview for depression )
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able to identify at least one impulsive, problematic behaviour to target during the intervention;
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participants will require working knowledge of written and spoken English, sufficient to be able to make use of therapy and to be able complete research assessments without the need of a translator.
Exclusion Criteria:
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major depressive episode (identified through SCID-DSM-5);
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current experience of mania;
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current/past learning disability (IQ of less than 70 with impairment of social and adaptive functioning)
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organic brain change or substance dependence (drugs and alcohol) that would compromise ability to use therapy;
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current marked risk to self (i.e. self-harm or suicide) that we deem could not be appropriately managed in by the therapy site;
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currently lacking capacity to give informed consent;
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currently receiving other psychosocial therapy for impulsivity or bipolar disorder;
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current engagement in another psychological intervention addressing bipolar disorder or impulsivity;
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presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AccEPT Clinic | Exeter | Devon | United Kingdom | EX4 4QG |
Sponsors and Collaborators
- University of Exeter
- Southern Health NHS Foundation Trust
- Somerset NHS Foundation Trust
- Devon Partnership NHS Trust
Investigators
- Principal Investigator: Jan Freeman, MSc, University of Exeter
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-23-07