CBT for Mood-Driven, Problematic, Impulsive Behaviours in Bipolar Disorder: A Case Series Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- University of Exeter
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes in management of impulsivity measured by the Visual Analogue Scale
Study Overview
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:
- Whether CBT Is a feasible intervention for participants with BD who report mood-driven, problematic impulsive behaviours.
- Whether CBT for mood-driven, problematic impulsive behaviours (CBT-PIB) is acceptable to service users with BD and therapists.
- 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:
- conduct a preliminary examination of the safety of CBT-PIB and the research procedures.
- gather information on the potential mechanisms of action of CBT-PIB and,
- gather information on the types of mood-driven impulsive behaviours individuals with BD may seek support for.
Participants will:
- be offered up to 12 individual sessions of CBT focusing on mood-driven impulsive behaviours.
- be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment.
- 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.
- be asked to complete a survey on the acceptability of the intervention and
- be invited to an optional semi-structured interview on their research experience.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •meeting diagnostic criteria for Bipolar I or II Disorder (SCID-5- Structured clinical interview for depression )
- •able to identify at least one impulsive, problematic behaviour to target during the intervention;
- •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
- •major depressive episode (identified through SCID-DSM-5);
- •current experience of mania;
- •current/past learning disability (IQ of less than 70 with impairment of social and adaptive functioning)
- •organic brain change or substance dependence (drugs and alcohol) that would compromise ability to use therapy;
- •current marked risk to self (i.e. self-harm or suicide) that we deem could not be appropriately managed in by the therapy site;
- •currently lacking capacity to give informed consent;
- •currently receiving other psychosocial therapy for impulsivity or bipolar disorder;
- •current engagement in another psychological intervention addressing bipolar disorder or impulsivity;
- •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).
Arms & Interventions
CBT for mood driven, problematic, impulsive behaviours
All participants will be offered the 12 week CBT intervention
Intervention: Cognitive Behavioural Therapy for Problematic Impulsive Behaviours (Behavioral)
Outcomes
Primary Outcomes
Changes in management of impulsivity measured by the Visual Analogue Scale
Time Frame: Through study completion, an average of 18 weeks
Visual scale measuring the severity and impact of general and behavioural impulsivity
Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB
Time Frame: 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)
Time Frame: 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
Time Frame: Through study completion, an average of 18 weeks
scale that assesses the presence and severity of manic or hypomanic symptoms
Number of participants with intervention-related adverse events assessed by the adverse events form
Time Frame: Through study completion, an average of 18 weeks
qualitative form eliciting adverse events
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)