Shared decision making in Bipolar Disorder
Research type
Research Study
Full title
A randomised feasibility trial of a patient app and health-record-integrated care team interface to facilitate shared decision making for people with bipolar disorders under maintenance care versus usual care (SDM-BD)
IRAS ID
347987
Contact name
Allan Young
Contact email
Sponsor organisation
King’s College London
Duration of Study in the UK
1 years, 4 months, 11 days
Research summary
Bipolar disorder (BD) is a long-term condition characterised by recurrent periods of depression and/or mania, separated by periods of stability. BD is rather common and can profoundly impact the duration and quality of patients' lives. While BD treatment often leads to improvement in patients' conditions, the disorder’s nature coupled with complex treatments results in estimated medication nonadherence rates of up to 80%, which contributes to higher relapse and hospitalisation rates. In recent years, the concept of Shared Decision Making (SDM) has emerged as a method to encourage collaboration between patient and clinician, thereby making the patient more engaged and more likely to adhere to their treatment regimen. However, the implementation of SDM within routine mental health care has been limited by a lack of high quality, accessible tools/services.
A company, Fora Health, have created a digital platform that aims to address this issue by facilitating ongoing monitoring and communication between patients and doctors. This study seeks to (a) develop a version of this service that is tailored to BD patients, and (b) assess its adoption, usability and effectiveness. The study, funded by the National Institute for Health and Care Research (NIHR), will recruit 120 people aged 18+ who are being treated for BD within South London and Maudsley NHS Foundation Trust (SLaM), alongside their clinicians. Participants will be randomised 1:1 to one of two conditions. One group will continue treatment as usual (TAU) alongside regular use of the Fora Health platform for 6 months, while the other will undergo TAU without using the platform.
The study will consist of six visits, all conducted remotely (e.g., via Microsoft Teams). These are as follows:
• Screening – eligibility assessment
• Baseline – initial assessments and randomisation
• Weeks 3, 8 and 13 – assessment of BD symptoms and engagement with the platform
• Week 26 –final round of questionnaires/assessmentsREC name
West of Scotland REC 5
REC reference
25/WS/0092
Date of REC Opinion
9 Jul 2025
REC opinion
Further Information Favourable Opinion