Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change
Bipolar disorder
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_BAR]) + Treatment As Usual (TAU) (treatment condition) to TAU alone (control condition). Outcome and mediational variables will be collected at baseline, 17 weeks, 27 weeks (after therapy cessation), and 52 weeks. Up to 26 individual weekly therapy sessions of up to 60 mins will be offered within a 26-week treatment window. Participants will be randomized to one of two trial arms. Randomization will be independent and concealed, using permuted stratified blocks where site (5-levels) and BAR group (3-levels) are the stratification factors. It will be conducted via a web-based system conducted within York Clinical Trials Unit (CTU). The intervention will be a novel Cognitive Behaviour Therapy (called CBT_BAR). The trial therapist will be delivering CBT_BAR in a 26-week treatment envelope allowing up to 26 sessions as follows: 1. Mood continuum work 2. Problem list generation 3. Goal setting 4. Idiosyncratic formulation (maintenance and longitudinal) derived from model 5. In-session measurement of appraisals and behaviour 6. Cognitive strategies to target key appraisals of mood: advantages/disadvantages; 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 TEAMS). Flexibility was a key theme found in the qualitative work conducted with the participants from the original BART trial conducted in 2015-2018. The control condition is treatment as usual (TAU), consisting of multi-disciplinary care delivered by a range of health professionals and services such as
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 a
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