The goal of this clinical trial is to learn whether MoodSync, a mobile application for patients and their family caregivers, improves mood stability, medication adherence, daily functioning and early detection of relapse warning signs in adults with severe mental illness in Bahrain. The main question it aims to answer is: Does MoodSync plus standard care improve manic symptoms, medication adherence, practical and social functioning, and early warning signs more than standard care alone?
Participants will be randomly assigned to MoodSync plus standard care or standard care alone. MoodSync participants will use the patient app for 12 weeks for daily mood check-ins, sleep and activity tracking with a wearable device, medication reminders, daily-routine (social rhythm) support and early warning-sign reporting. A nominated family caregiver may use the linked caregiver app. All participants continue standard care and complete questionnaires before and after the intervention period.
Research hypothesis:
\* Patients who use MoodSync will show greater improvement in mood symptoms, medication adherence, practical and social functioning, and relapse-related outcomes than patients receiving standard care alone.
Adults aged 18 years or older
Diagnosis of a severe mental illness (bipolar I or II disorder, schizophrenia, schizoaffective disorder, or major depressive disorder) according to DSM-5-TR, confirmed by the treating psychiatrist
Clinically stable, defined as no psychiatric hospital admission in the previous 3 months
Receiving care at a participating mental health service
Acute psychiatric crisis at the time of recruitment
Inability to provide informed consent
Severe cognitive impairment preventing use of the application
No access to a compatible mobile device, unless one is provided by the project
Parallel
MoodSync
BehavioralA just-in-time dual mobile application (patient and family-caregiver versions) for daily mood monitoring, sleep and activity tracking via a wearable device, medication-adherence reminders, social rhythm regulation and early warning-sign reporting, used for 12 weeks. A nominated family caregiver may use the caregiver app with the patient's consent. High-risk alerts follow a predefined clinical safety protocol with referral to the responsible healthcare provider. The app does not replace clinical care.
Standard care
Other interventionParticipants continue routine psychiatric care, including clinic follow-up and prescribed medication, and complete the same assessments at baseline and post-test.
Manic symptoms - Altman Self-Rating Mania Scale (ASRM)
Five self-rated items (elevated mood, self-confidence, need for sleep, talkativeness, activity), each scored 0-4; total 0-20. Higher scores indicate more severe manic symptoms; a score of 6 or more suggests probable mania or hypomania.
Medication adherence - Morisky-Green-Levine Medication Adherence Scale (4 items)
Four yes/no items on forgetting, carelessness and stopping medication when feeling better or worse. Score 0-4 (number of non-adherent answers). Higher scores indicate lower adherence.
Practical and social functioning - Practical and Social Functioning Scale (PSF)
28 items in seven 4-item subscales (personal hygiene, domestic tasks, financial management, social contact, communication, work and leisure, transport and travel), forming activity and participation dimensions. Each item rated 1 (does not match) to 5 (matches completely); total score 28-140. Higher scores indicate better functioning (Clausen \& Ruud, 2024).
Early warning signs of relapse - Early Signs Scale (ESS)
Self-report scale of early warning signs of relapse (Birchwood et al., 1989), each sign rated on a four-point frequency scale from 0 (no problem) to 3 (marked problem). Higher scores indicate more frequent or more severe early warning signs.
Relapse-related events
Number of participants with a psychiatric hospital admission, emergency department visit or crisis contact, from clinical records.
Family caregiver involvement
In the MoodSync group: percentage of days on which the nominated family caregiver used the caregiver app, and percentage of high-risk alerts acknowledged by the caregiver, from app logs.
App engagement
In the MoodSync group: percentage of days with a completed mood check-in and percentage of medication reminders confirmed, from app logs.
Usability - System Usability Scale (SUS)
Ten items rated on a 5-point scale, converted to a total score of 0-100, completed by MoodSync patients and caregivers. Higher scores indicate better usability; a score above 68 is above average. Cronbach's alpha 0.91 (Bangor, Kortum \& Miller, 2008).
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Alexandria University
Lead sponsor
University of Bahrain
Collaborator
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