ImpulsivityNCT06129500
CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB
A study testing Cognitive Behavioural Therapy for Problematic Impulsive Behaviours in people with Impulsivity and Bipolar Disorder, run by University of Exeter at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impulsivity, Bipolar Disorder, Hypomania
- What is being tested?
- Cognitive Behavioural Therapy for Problematic Impulsive Behaviours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Aug 2023to 24 Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CBT for Mood-Driven, Problematic, Impulsive Behaviours in Bipolar Disorder: A Case Series Evaluation
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:
Read more
- 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
- Being tested
- Cognitive Behavioural Therapy for Problematic Impulsive Behaviours
- Medical subject headings
- Impulsive Behavior, Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Problematic Impulsive BehavioursBehavioural
Up to 12 sessions of Cognitive Behavioural Therapy adapted to focus on mood-driven impulsivity in adults with bipolar disorder.
| Study group | Role | What they receive |
|---|---|---|
| CBT for mood driven, problematic, impulsive behaviours | Experimental | All participants will be offered the 12 week CBT intervention Receives: Behavioral: Cognitive Behavioural Therapy for Problematic Impulsive Behaviours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB
qualitative and quantitative feedback from participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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
self-report measure of changes in disorder-specific quality of life
Measured: 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)
scale measuring changes in symptoms of anxiety
Measured: 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
scale measuring changes in positive features of mental health
Measured: 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
Scale measuring changes in 5 domains of impulsive behaviour
Measured: At baseline, in 2 weeks and in 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start17 Aug 2023
- Primary completion10 Sep 2026 (estimated)
- Study completion24 Jan 2027 (estimated)
Why it stopped: Paused due to change in staffing arrangements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpulsivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Health NHS Foundation Trust, Somerset NHS Foundation Trust, Devon Partnership NHS Trust
- Responsible party
- Sponsor
- Investigators
- Jan Freeman, MSc, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129500
- Sponsor's protocol ID
- 2022-23-07
- Status last verified
- Apr 2025
- First submitted
- 26 Oct 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Mood-Driven, Problematic, Impulsive Behaviours in Bipolar Disorder: A Case Series Evaluation
- ClinicalTrials.gov ID
- NCT06129500
- Acronym / sponsor ID
- 2022-23-07
- Conditions
- Impulsivity, Bipolar Disorder, Hypomania, Bipolar I Disorder, Bipolar II Disorder, Bipolar Affective Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Paused due to change in staffing arrangements
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Southern Health NHS Foundation Trust, Somerset NHS Foundation Trust, Devon Partnership NHS Trust
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBT for mood driven, problematic, impulsive behaviours | Experimental | Behavioral: Cognitive Behavioural Therapy for Problematic Impulsive BehavioursAll participants will be offered the 12 week CBT intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for Problematic Impulsive BehavioursUp to 12 sessions of Cognitive Behavioural Therapy adapted to focus on mood-driven impulsivity in adults with bipolar disorder. | Behavioural | CBT for mood driven, problematic, impulsive behaviours |
Primary outcome
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
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
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
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
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
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Yes. All data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Freeman, MSc principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Problematic Impulsive Behaviours in people with Impulsivity and Bipolar Disorder, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB (time frame: Post-intervention at week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.