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Paused due to change in staffing arrangements
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| Name | Class |
|---|---|
| Southern Health NHS Foundation Trust | OTHER |
| Somerset NHS Foundation Trust | OTHER |
| Devon Partnership NHS Trust | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for mood driven, problematic, impulsive behaviours | Experimental | All participants will be offered the 12 week CBT intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy for Problematic Impulsive Behaviours | Behavioral | Up to 12 sessions of Cognitive Behavioural Therapy adapted to focus on mood-driven impulsivity in adults with bipolar disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Freeman, MSc | University of Exeter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AccEPT Clinic | Exeter | Devon | EX4 4QG | United Kingdom |
All data that underlie results in a publication.
Access will be possible from date of publication.
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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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.
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| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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