CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB

Not Applicable

Recruiting

• Conditions: Impulsive Behavior; Bipolar Disorder; Hypomania; Bipolar Affective Disorder; Impulsivity; Bipolar II Disorder; Bipolar I Disorder
• Interventions: Behavioral: Cognitive Behavioural Therapy for Problematic Impulsive Behaviours

• Registration Number: NCT06129500
• Lead Sponsor: University of Exeter

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-17
• Study First Submitted: 2023-10-26
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT for mood driven, problematic, impulsive behaviours	Cognitive Behavioural Therapy for Problematic Impulsive Behaviours	All participants will be offered the 12 week CBT intervention

Primary Outcome Measures

Name	Time	Method
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
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
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

Name	Time	Method
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
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 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 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

Trial Locations

Locations (1)

AccEPT Clinic; 🇬🇧 Exeter, Devon, United Kingdom