An interventional study of Cognitive Behavioural Therapy for Problematic Impulsive Behaviours in Impulsivity, Bipolar Disorder and Hypomania, sponsored by University of Exeter. Suspended at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by University of Exeter · Not applicable, Interventional, and Treatment
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:
The study also hopes to:
Participants will:
158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 128 interventional studies indexed under Impulsive Behavior.
Browse Impulsive Behavior studies →University of Exeter is the lead sponsor of 140 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Overall acceptability and feasibility of the CBT protocol measured by the Client Satisfaction Questionnaire CBT-PIB
qualitative and quantitative feedback from participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 18 weeks
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.
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
self-report measure of changes in disorder-specific quality of life
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)
scale measuring changes in symptoms of anxiety
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
scale measuring changes in positive features of mental health
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
Scale measuring changes in 5 domains of impulsive behaviour
Time frame: At baseline, in 2 weeks and in 14 weeks
Plan to share: Yes — All data that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
This study is suspended, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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