An interventional study of MoodSync and Standard care in Severe Mental Illness, Bipolar Disorder and Schizophrenia, sponsored by Alexandria University. Not yet recruiting at 1 site in Bahrain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care
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.
Severe mental illness is associated with difficulties in emotional regulation, social functioning and medication adherence, and social dysfunction is a strong predictor of relapse. Conventional follow-up relies on episodic clinic visits and retrospective self-report, which may miss early changes in mood, sleep and adherence. Mobile health tools allow continuous monitoring, personalised feedback and early intervention in the patient's daily setting, but few integrate mood monitoring, social rhythm regulation, medication adherence, family involvement and relapse prevention in one culturally adapted platform.
Design: two-arm, parallel-group randomized controlled trial with pretest and post-test measurement.
Randomization: 60 participants are allocated 1:1 (30 per group) using a computer-generated sequence, with allocation concealed until baseline data collection is complete.
Intervention: MoodSync is a dual application (patient app and family-caregiver app) providing daily mood monitoring, sleep and activity tracking through a wearable device (30 devices provided to the intervention group), medication-adherence reminders, social rhythm regulation and early warning-sign reporting. The app is a supportive self-management tool and does not replace clinical care or diagnosis. A predefined clinical safety protocol guides the response to high-risk alerts or signs of deterioration, including timely referral to the responsible healthcare provider.
Analysis: between-group differences in post-test outcomes are tested with analysis of covariance adjusted for baseline scores, or mixed-effects models, with effect sizes. App-use data, adherence patterns, system alerts and wearable indicators are analysed in aggregate.
2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.
This study's planned enrollment of 60 is below the median of 96 across 1,607 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Alexandria University is the lead sponsor of 586 studies on the registry; 128 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Family caregivers (intervention group, optional): adult family member nominated by the participant, who gives separate written informed consent.
MoodSync patient app and wearable device for 12 weeks, with optional caregiver app, in addition to standard care.
Behavioral: MoodSync
Standard care at the participating mental health service.
Other: Standard care
A 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.
Participants 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.
Time frame: Baseline and end of the 12-week intervention
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.
Time frame: Baseline and end of the 12-week intervention
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).
Time frame: Baseline and end of the 12-week intervention
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.
Time frame: Baseline and end of the 12-week intervention
Relapse-related events
Number of participants with a psychiatric hospital admission, emergency department visit or crisis contact, from clinical records.
Time frame: From randomization to end of the 12-week intervention
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.
Time frame: Over the 12-week intervention
App engagement
In the MoodSync group: percentage of days with a completed mood check-in and percentage of medication reminders confirmed, from app logs.
Time frame: Over the 12-week intervention
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).
Time frame: End of the 12-week intervention
Retention
Percentage of randomized participants in each group who complete the post-test assessment.
Time frame: End of the 12-week intervention
Plan to share: No — Individual participant data are held under the conditions of the ethics approvals; de-identified summary data may be shared on reasonable request to the principal investigator.
Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.
Of 841 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 856 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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