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

• ClinicalTrials.gov Identifier: NCT06129500
• Recruitment Status: Recruiting
• First Posted: November 13, 2023
• Last Update Posted: November 13, 2023
• Sponsor: University of Exeter
• Collaborators: Southern Health NHS Foundation Trust; Somerset NHS Foundation Trust; Devon Partnership NHS Trust
• Information provided by (Responsible Party): University of Exeter

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:

• 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.

Condition or disease	Intervention/treatment	Phase
Impulsivity; Bipolar Disorder; Hypomania; Bipolar I Disorder; Bipolar II Disorder; Bipolar Affective Disorder; Impulsive Behavior	Behavioral: Cognitive Behavioural Therapy for Problematic Impulsive Behaviours	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment

Intervention Model Description

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.

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CBT for Mood-Driven, Problematic, Impulsive Behaviours in Bipolar Disorder: A Case Series Evaluation
• Actual Study Start Date: August 17, 2023
• Estimated Primary Completion Date: June 10, 2024
• Estimated Study Completion Date: June 24, 2024

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 :

1. 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
2. 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
3. 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
4. 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
5. 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 Outcome Measures :

1. rates of clinically significant and reliable change in general daily functioning as measured by the Work and Social Adjustment Scale [ Time Frame: 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.
2. rates of clinically significant and reliable change in quality of life as measured by the Brief Quality of Life in Bipolar Disorder [ Time Frame: At baseline, 2 weeks and 14 weeks ]
   self-report measure of changes in disorder-specific quality of life
3. rates of clinically significant and reliable change in symptoms of anxiety as measured by the General Anxiety Disorder Assessment (GAD7) [ Time Frame: At baseline, in 2 weeks and in 14 weeks ]
   scale measuring changes in symptoms of anxiety
4. rates of clinically significant and reliable change in overall wellbeing as measured by the Warwick-Edinburgh Mental Well-being Scale [ Time Frame: At baseline, in 2 weeks and in 14 weeks ]
   scale measuring changes in positive features of mental health
5. 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 [ Time Frame: At baseline, in 2 weeks and in 14 weeks ]
   Scale measuring changes in 5 domains of impulsive behaviour

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Jan Freeman, MSc; 01392 726449; jf693@exeter.ac.uk

Contact: Kim Wright, DClniPsy; 01392 726449; accept.clinic@nhs.net

Locations

United Kingdom

AccEPT Clinic; Recruiting

Exeter, Devon, United Kingdom, EX4 4QG

Contact: Jan Freeman, MSc 01392 726449 jf693@exeter.ac.uk

Contact: Kim Wright, DClinPsy 01392 726449 accept.clinic@nhs.net

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

More Information

• Responsible Party: University of Exeter
• ClinicalTrials.gov Identifier: NCT06129500
• Other Study ID Numbers: 2022-23-07
• First Posted: November 13, 2023
• Last Update Posted: November 13, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All data that underlie results in a publication.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mania; Bipolar Disorder; Mood Disorders; Impulsive Behavior; Bipolar and Related Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases