Bipolar disorder Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 12/02/2026:
This is a single-centre randomised feasibility study of 120 people with Bipolar Disorder (BD). Participants aged 18+ with a diagnosis of BD, who are not in an
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older at study entry (via patient report) 2. Meet DSM-5 criteria for a bipolar disorder (type I, type II, or NOS), with onset before age 50 years, as reported by the clinician 3. Undergoing care within South London & Maudsley NHS Trust and has an identified clinician who is willing and able to provide separate written informed consent (Please note that there are no specific criteria relating to clinicians' inclusion, besides their responsibility for the patient) 4. Ability to provide informed consent to participate 5. Access to an internet-enabled device that is supported by the Fora Health application, according to the minimum system requirements
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 13/04/2026: 1. Currently in an acute bipolar episode (as reported by clinician) 2. Comorbid substance dependence, as determined by a score of 27 or higher on any domain of the Alcohol, Smoking and Substance Involvement Screening Test v3.1 (ASSIST) 3. Comorbid organic neurological disorder (as per patient report) 4. Unable to read and understand the participant information sheet and inability to communicate with the researcher throughout the screening assessment 5. Participation/enrolment in another clinical trial or research study that may interfere with the objectives/assessments of the present study Previous key exclusion criteria as of 27/02/2026: 1. Currently in an acute bipolar episode (as reported by clinician) 2. Comorbid substance dependence, as determined by a score of 27 or higher on any domain of the Alcohol, Smoking and Substance Involvement Screening Test v3.1 (ASSIST) 3. Comorbid organic neurological disorder (as per patient report) 4. Unable to read and understand the participant information sheet, plus the ability to communicate with the researcher throughout the screening assessment 5. Participation/enrolment in another clinical trial or research study that may interfere with the objectives/assessments of the present study Previous key exclusion criteria: 1. Currently in an acute bipolar episode (as reported by clinician) 2. Comorbid substance dependence within three months of screening, as determined by a score of 27 or higher on any domain of the Alcohol, Smoking and Substance Involvement Screening Test v3.0 (ASSIST) 3. Comorbid organic neurological disorder (as per patient report) 4. Unable to communicate fluently in English (defined as the ability to read and understand the participant information sheet, plus the ability to communicate with the researcher throughout the screening assessment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The practicality of using the service alongside NHS services for patients with BD in terms of delivery and maintenance of the intervention will be measured using data collected during a structured audit of intervention delivery (in terms of fidelity, service integration, and training) at weeks 13 and 26 and feedback from qualitative interviews following participants’ week 26 visits. 2.Acceptability of how the service meets the needs of patients and care teams around SDM, measured using the Patient Health Engagement Scale (PHES) at baseline and weeks 3, 8, 13, and 26, System Usability Scale at week 26, and semi-structured interviews with patients and clinicians following participants’ week 26 visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Data collected using the four secondary outcome measures may be used in the design of future trials: 1. Stable mood state will be measured using the following patient-report scales of low and elevated affective states at baseline and weeks 3, 8, 13, and 26: 1.1. The Maudsley 3-item Visual Analogue Scale (M3VAS) 1.2. The Quick Inventory of Depressive Symptomatology (QIDS) 1.3. The Young Mania Rating Scale (YMRS) 2. Patient confidence measured using the Health Confidence tool at baseline and weeks 3, 8, 13, and 26 3. Shared decision making measured using the M-PICS and the CollaboRATE tool at baseline and week 26 4. Costs and economic outcomes measured by EQ5D-5L and Client Service Receipt Inventory at baseline and week 26 | — |
Countries
England, United Kingdom
Contacts
Public ContactAllan;Paul Young;Leeks
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Outcome results
None listed