Severe Mental IllnessMoodSyncNCT07879131
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
A study testing MoodSync in people with Severe Mental Illness and Bipolar Disorder, run by Alexandria University at 1 site in Bahrain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness, Bipolar Disorder, Schizophrenia
- What is being tested?
- MoodSync
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBahrain
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Able to use a smartphone application
- Able to provide written informed consent
Who cannot join
- 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
- Family caregivers (intervention group, optional): adult family member nominated by the participant, who gives separate written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bahrain1 site
Psychiatric Hospital, Government Hospitals
Manama
Rasha Eweida, +973 37510883, reweida@uob.edu.bh
About this study
Official title: Effectiveness of MoodSync: A Just-in-Time Dual Mobile Application for Mood Monitoring, Social Rhythm Regulation, Medication Adherence, and Relapse Prevention Among Patients With Severe Mental Illness: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Severe Mental Illness, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Major Depressive Disorder
- Being tested
- MoodSync, Standard care
- Keywords
- Mobile health (mHealth), Smartphone application, Mood monitoring, Social rhythm, Medication adherence, Relapse prevention, Early warning signs, Wearable devices, Family caregivers, Bahrain
- Medical subject headings
- Mental Disorders, Bipolar Disorder, Schizophrenia, Psychotic Disorders, Depressive Disorder, Major, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodSyncBehavioural
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.
Standard careOther
Participants continue routine psychiatric care, including clinic follow-up and prescribed medication, and complete the same assessments at baseline and post-test.
| Study group | Role | What they receive |
|---|---|---|
| MoodSync Group | Experimental | MoodSync patient app and wearable device for 12 weeks, with optional caregiver app, in addition to standard care. Receives: Behavioral: MoodSync |
| Standard Care Group | Active comparator | Standard care at the participating mental health service. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and end of the 12-week intervention
Secondary outcomes (5)
Relapse-related events
Number of participants with a psychiatric hospital admission, emergency department visit or crisis contact, from clinical records.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: End of the 12-week intervention
Retention
Percentage of randomized participants in each group who complete the post-test assessment.
Measured: End of the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bahrain
- Responsible party
- Principal investigator, Rasha salah elsayed eweida, Alexandria University
- Investigators
- Rasha S Eweida, Principal investigator, University of Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879131
- Sponsor's protocol ID
- 121335668
- Acronym
- MoodSync
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Liu X, Cruz Rivera S, Moher D, Calvert MJ, Denniston AK; SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. Nat Med. 2020 Sep;26(9):1364-1374. doi: 10.1038/s41591-020-1034-x. Epub 2020 Sep 9.
PubMed 32908283Cruz Rivera S, Liu X, Chan AW, Denniston AK, Calvert MJ; SPIRIT-AI and CONSORT-AI Working Group; SPIRIT-AI and CONSORT-AI Steering Group; SPIRIT-AI and CONSORT-AI Consensus Group. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. Nat Med. 2020 Sep;26(9):1351-1363. doi: 10.1038/s41591-020-1037-7. Epub 2020 Sep 9.
PubMed 32908284Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116-119. doi: 10.1136/eb-2018-102891. Epub 2018 Jun 5.
PubMed 29871870Clausen H, Ruud T. The Practical and Social Functioning (PSF) scale: development and measurement properties of an instrument for assessing activity and social participation among people with serious mental illness. BMC Psychiatry. 2024 Oct 16;24(1):693. doi: 10.1186/s12888-024-06135-x.
PubMed 39415117Birchwood M, Smith J, Macmillan F, Hogg B, Prasad R, Harvey C, Bering S. Predicting relapse in schizophrenia: the development and implementation of an early signs monitoring system using patients and families as observers, a preliminary investigation. Psychol Med. 1989 Aug;19(3):649-56. doi: 10.1017/s0033291700024247.
PubMed 2798634American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Washington, DC: American Psychiatric Association Publishing; 2022.
World Health Organization. World mental health report: transforming mental health for all. Geneva: WHO; 2022.
WHO guideline Recommendations on Digital Interventions for Health System Strengthening. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK541902/
PubMed 31162915