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

Bipolar Disorder Clinical Trial

Official title:

CBT for Mood-Driven, Problematic, Impulsive Behaviours in Bipolar Disorder: A Case Series Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129500
• Other study ID #: 2022-23-07
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: June 24, 2024

Study information

• Verified date: November 2023
• Source: University of Exeter
• Contact: Jan Freeman, MSc
• Phone: 01392 726449
• Email: jf693[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 24, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Hypomania
• Impulsive Behavior
• Impulsivity
• Mania
• Mood Disorders

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.

Locations

Country	Name	City	State
United Kingdom	AccEPT Clinic	Exeter	Devon

Sponsors (4)

Lead Sponsor	Collaborator
University of Exeter	Devon Partnership NHS Trust, Somerset NHS Foundation Trust, Southern Health NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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