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

NCT06129500 | Suspended

• 1 other identifier: 2022-23-07
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB

  qualitative and quantitative feedback from participants

  Post-intervention at week 16

• rates of clinically significant and reliable change in mood measured by the Patient health questionnaire (PHQ-9)

  used to monitor the severity of depression and response to treatment

  Through study completion, an average of 18 weeks

• rates of clinically significant and reliable change in symptoms of mania measured by the Altman Self-Rating Mania Scale

  scale that assesses the presence and severity of manic or hypomanic symptoms

  Through study completion, an average of 18 weeks

• Changes in management of impulsivity measured by the Visual Analogue Scale

  Visual scale measuring the severity and impact of general and behavioural impulsivity

  Through study completion, an average of 18 weeks

• Number of participants with intervention-related adverse events assessed by the adverse events form

  qualitative form eliciting adverse events

  Through study completion, an average of 18 weeks

Secondary Outcomes (5)

• 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 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 overall wellbeing as measured by the Warwick-Edinburgh Mental Well-being Scale

  At baseline, in 2 weeks and in 14 weeks

• 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

Study Arms (1)

CBT for mood driven, problematic, impulsive behaviours

EXPERIMENTAL

All participants will be offered the 12 week CBT intervention

Behavioral: Cognitive Behavioural Therapy for Problematic Impulsive Behaviours

Interventions

Cognitive Behavioural Therapy for Problematic Impulsive Behaviours BEHAVIORAL

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

CBT for mood driven, problematic, impulsive behaviours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Exeter: lead
• Southern Health NHS Foundation Trust: collaborator
• Somerset NHS Foundation Trust: collaborator
• Devon Partnership NHS Trust: collaborator

Study Sites (1)

AccEPT Clinic

Exeter, Devon, EX4 4QG, United Kingdom

Location

MeSH Terms

Conditions

Impulsive Behavior; Bipolar Disorder; Mania

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jan Freeman, MSc

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project will follow an ABA case-series design. In an ABA design, for an individual receiving a treatment there is a measurement period (baseline) before the treatment phase, and then again after the treatment phase, to allow exploration of the apparent stability of any changes observed over the treatment period. Participants will be assigned to a two-week baseline phase, up to twelve-session intervention phase, and a two-week post-intervention phase. This will allow for three baseline measurements, to establish symptom and mood stability prior to treatment, and a two-week post-intervention measurement phase to explore the stability of any intervention-related changes. Symptoms will be measured weekly across the baseline period, treatment phase and post-treatment periods. Participants will also complete additional self-report measures and be invited to participate in a semi structured interview to gather qualitative feedback post treatment.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 13, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): January 24, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Access will be possible from date of publication.
• Access Criteria: The research database will be registered with the University of Exeter public access database. The dataset will be anonymous and will be registered with a metadata only record, allowing the research team to control access to the dataset, restricting it to appropriately qualified third parties.

Locations

GB (1)