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

NCT ID: NCT06129500

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2027-01-24

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.

Conditions

Impulsivity; Bipolar Disorder; Hypomania; Bipolar I Disorder; Bipolar II Disorder; Bipolar Affective Disorder; Impulsive Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT for mood driven, problematic, impulsive behaviours

All participants will be offered the 12 week CBT intervention

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy for Problematic Impulsive Behaviours

Intervention Type: BEHAVIORAL

Up to 12 sessions of Cognitive Behavioural Therapy adapted to focus on mood-driven impulsivity in adults with bipolar disorder.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Health NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Somerset NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Devon Partnership NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Freeman, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

AccEPT Clinic

Exeter, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

2022-23-07

Identifier Type: -

Identifier Source: org_study_id