Bipolar At Risk Trial II (BART II)
Research type
Research Study
Full title
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
IRAS ID
316335
Contact name
Sophie Parker
Contact email
Sponsor organisation
Greater Manchester Mental Health NHS Foundation Trust
ISRCTN Number
ISRCTN13363197
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Our trial will be a multicentre, raterblinded randomised control trial (RCT) with 2 parallel arms. It will compare a psychological intervention (Cognitive Behavioural Therapy for Bipolar At Risk (CBT_BAR)) + (treatment condition (TAU)) to TAU alone (control condition).
For those who are randomsied to receive the CBT_BAR, up to 26 individual weekly therapy sessions of up to 60 mins will be offered.
Outcome and mediational variables will be collected at baseline, 17-weeks (during treatment window capturing Structured Clinical Interview for Axis 1 Disorders (SCID-5) with Positive Symptom Ratings (PSR's), Hypomanic Positive Predictions Inventory (HAPPI), Internal States Scale (ISS), and the Behaviour Checklist (BC)), 27-weeks (after therapy cessation), and at 52-weeks.
Participants will be randomised to one of two trial arms. Randomisation 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.
The research objective is to recruit 338 participants across 5 NHS sites (representing 4 NHS commissioning regions in England: Greater Manchester, Lancashire, Sheffield, Birmingham, and Norfolk & Suffolk), who meet the Bipolar At Risk (BAR) criteria.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
22/NW/0355
Date of REC Opinion
13 Dec 2022
REC opinion
Further Information Favourable Opinion