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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06129500
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : November 13, 2023
Sponsor:
Collaborators:
Southern Health NHS Foundation Trust
Somerset NHS Foundation Trust
Devon Partnership NHS Trust
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06129500


Contacts
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Contact: Jan Freeman, MSc 01392 726449 jf693@exeter.ac.uk
Contact: Kim Wright, DClniPsy 01392 726449 accept.clinic@nhs.net

Locations
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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
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Principal Investigator: Jan Freeman, MSc University of Exeter
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT06129500    
Other Study ID Numbers: 2022-23-07
First Posted: November 13, 2023    Key Record Dates
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mania
Bipolar Disorder
Mood Disorders
Impulsive Behavior
Bipolar and Related Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases