Clinical trial NCT06129500: CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB
Official title: CBT for Mood-Driven, Problematic, Impulsive Behaviours in Bipolar Disorder: A Case Series Evaluation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Impulsivity
Bipolar Disorder
Hypomania
Bipolar I Disorder
Bipolar II Disorder
Bipolar Affective Disorder
Impulsive Behavior
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Southern Health NHS Foundation Trust
name: Somerset NHS Foundation Trust
name: Devon Partnership NHS Trust
First posted: 2023-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB
timeFrame: Post-intervention at week 16
measure: rates of clinically significant and reliable change in mood measured by the Patient health questionnaire (PHQ-9)
timeFrame: Through study completion, an average of 18 weeks
measure: rates of clinically significant and reliable change in symptoms of mania measured by the Altman Self-Rating Mania Scale
timeFrame: Through study completion, an average of 18 weeks
measure: Changes in management of impulsivity measured by the Visual Analogue Scale
timeFrame: Through study completion, an average of 18 weeks
measure: Number of participants with intervention-related adverse events assessed by the adverse events form
timeFrame: Through study completion, an average of 18 weeks
Secondary outcomes:
measure: rates of clinically significant and reliable change in general daily functioning as measured by the Work and Social Adjustment Scale
timeFrame: At baseline, 2 weeks and 14 weeks
measure: rates of clinically significant and reliable change in quality of life as measured by the Brief Quality of Life in Bipolar Disorder
timeFrame: At baseline, 2 weeks and 14 weeks
measure: rates of clinically significant and reliable change in symptoms of anxiety as measured by the General Anxiety Disorder Assessment (GAD7)
timeFrame: At baseline, in 2 weeks and in 14 weeks
measure: rates of clinically significant and reliable change in overall wellbeing as measured by the Warwick-Edinburgh Mental Well-being Scale
timeFrame: At baseline, in 2 weeks and in 14 weeks
measure: 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
timeFrame: At baseline, in 2 weeks and in 14 weeks
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: AccEPT Clinic
state: Devon
Study officials:
affiliation: University of Exeter
name: Jan Freeman, MSc
role: PRINCIPAL_INVESTIGATOR
References: