Bipolar disorder Mental and Behavioural Disorders Bipolar affective disorder
Conditions
Interventions
This trial will be a multicentre, rater-blinded randomised control trial with two parallel arms. It will compare a psychological intervention (Cognitive Behavioural Therapy for Bipolar At Risk [CBT_BA
developing alternative explanations
evidential analysis
surveys
cognitive processes
beliefs of self, world and other.
7. Behavioural strategies: behavioural experiments
behavioural analysis including intended mood management
Sessions will be offered face-to-face, but we will also offer flexible appointments via video calls (using NHS trust-approved platforms such as
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 25 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 29/07/2026: The study population are young people meeting BAR criteria. The inclusion criteria are: 1. 16-25 years old 2. Meet criteria for one of the following groups in the last 12 months (as assessed by the SCID-5): 2.1. Group I: Sub-threshold mania. For at least 2 consecutive days but less than 7 days: period of abnormally and persistently elevated, expansive or irritable mood + at least 2 criteria from the list (>=3 for irritable mood): 2.1.1. Inflated self-esteem/grandiosity 2.1.2. Decreased need for sleep 2.1.3. More talkative than usual 2.1.4. Flight of ideas/racing thoughts 2.1.5. Distractibility 2.1.6. Increase goal-directed activity or psychomotor agitation 2.1.7. Excessive involvement in activities that have a high potential for painful consequences 2.2. Group II: Depression + Cyclothymic features: Depression (for at least 1 week): depressed mood/loss of interest or please + two criteria from the list: 2.2.1. Significant weight loss 2.2.2. Insomnia or hypersomnia nearly every day 2.2.3. Psychomotor retardation/agitation 2.2.4. Fatigue/loss of energy 2.2.5. Feelings of worthlessness/excessive or inappropriate guilt 2.2.6. Diminished ability to think or concentrate 2.2.7. Recurrent thoughts of death/suicidal ideation PLUS Cyclothymic features: numerous episodes with sub-threshold manic symptoms not meeting Group 1 criteria: subthreshold mania as defined in Group 1 for 4 hours within a 24-hour period and at least 4 cumulative lifetime days in the past 12 months. 2.3. Group III: Depression + genetic risk: Depression (See Group 2) PLUS Genetic risk: first degree relative with BD 3. Help seeking 4. Provision of written informed consent Previous key inclusion criteria: The study population are young people meeting BAR criteria. The inclusion criteria are: 1. 16-25 years old 2. Meet criteria for one of the following groups in the last 12 months (as assessed by the SCID-5): 2.1. Group I: Sub-threshold mania. For at least 2 consecutive days but less than 7 days: period of abnormally and persistently elevated, expansive or irritable mood + at least 2 criteria from the list (>=3 for irritable mood): 2.1.1. Inflated self-esteem/grandiosity 2.1.2. Decreased need for sleep 2.1.3. More talkative than usual 2.1.4. Flight of ideas/racing thoughts 2.1.5. Distractibility 2.1.6. Increase goal-directed activity or psychomotor agitation 2.1.7. Excessive involvement in activities that have a high potential for painful consequences 2.2. Group II: Depression + Cyclothymic features: Depression (for at least 1 week): depressed mood/loss of interest or please + two criteria from the list: 2.2.1. Significant weight loss 2.2.2. Insomnia or hypermania nearly every day 2.2.3. Psychomotor retardation/agitation 2.2.4. Fatigue/loss of energy 2.2.5. Feelings of worthlessness/excessive or inappropriate guilt 2.2.6. Diminished ability to think or concentrate 2.2.7. Recurrent thoughts of death/suicidal ideation PLUS Cyclothymic features: numerous episodes with sub-threshold manic symptoms not meeting Group 1 criteria: subthreshold mania as defined in Group 1 for 4 hours within a 24-hour period and at least 4 cumulative lifetime days in the past 12 months. 2.3. Group III: Depression + genetic risk: Depression (See Group 2) PLUS Genetic risk: first degree relative with BD 3. Help seeking 4. Provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. History of a treated/untreated manic episode or psychosis of 1-week duration or longer 2. Treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks (that evidences exclusion on point a or at the time of the assessment whereby at-risk status cannot be confirmed) 3. Organic brain disorder 4. Unable to complete assessments due to language barriers 5. Inpatient/acute psychiatric care needed 6. Primary substance abuse/dependency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood swing symptom severity averaged over the prior 4 weeks, measured by the SCID-5 + Psychiatric Status Ratings/PSRs (SCID Longitudinal Follow-Up Evaluation (LIFE) at the 27-week timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Appraisals of and responses to mood to determine the impact of CBT_BAR, measured by the Internal States Scale, Hypomanic Positive Predictions Inventory, and Behaviours Checklist at baseline, 17 weeks, 27 weeks, and 52 weeks 2. Transition to (hypo)mania, % of time in subthreshold symptoms, and time in symptoms, measured by the SCID LIFE (SCID-5 assessment, Modules A, B, C, & D + Psychiatric Rating Scores), the Young Mania Rating Scale, the Beck Depression Inventory, and the Altman Self Rating Scale at baseline and the 27-week and 52-week timepoints 3. Health utility and healthcare costs will be measured by the Service Use Interview, the EQ-5D, and the Recovering Quality of Life each measured at baseline, 27- and 52-week timepoints 4. Functioning and quality of life will be assessed by the Global Assessment of Functioning, Social and Occupational Functioning Assessment Scale, and the World Health Quality of Life at the baseline, 27- and 52-week timepoints 5. Sleep and related sleep appraisals will be assessed by the Pittsburgh Sleep Quality Index and the Positive and Negative Sleep Appraisal Measure at baseline, 27-week and 52- week timepoints 6. Metacognitive beliefs will be assessed by the Metacognitions Questionnaire and the Desire Thinking Questionnaire at baseline, 27-week, and 52-week timepoints 7. Response style and schema will be assessed by the Response Style Questionnaire and the Brief Core Schema Scale at baseline, 27-week and 52-week timepoints 8. Substance use, anxiety diagnoses, feeding & eating disorder, trauma & stress-related diagnoses, body dysmorphic disorders, and sleep/wake disorders will be assessed by the relevant SCID-5 module at baseline only | — |
Countries
England, United Kingdom
Outcome results
None listed