[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660392":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":62,"overallOfficials":72,"centralContacts":77,"locations":86,"responsibleParty":102,"collaborators":105,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":65,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":41,"enrollmentInfo":116,"targetDuration":41,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":129,"overallStatus":139,"whyStopped":41,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":41},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline and end of the 12-week intervention",{"measure":14,"description":15,"timeFrame":12},"Medication adherence - Morisky-Green-Levine Medication Adherence Scale (4 items)","Four yes\u002Fno 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.",{"measure":17,"description":18,"timeFrame":12},"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).",{"measure":20,"description":21,"timeFrame":12},"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.",[23,27,31,34,38],{"measure":24,"description":25,"timeFrame":26},"Relapse-related events","Number of participants with a psychiatric hospital admission, emergency department visit or crisis contact, from clinical records.","From randomization to end of the 12-week intervention",{"measure":28,"description":29,"timeFrame":30},"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.","Over the 12-week intervention",{"measure":32,"description":33,"timeFrame":30},"App engagement","In the MoodSync group: percentage of days with a completed mood check-in and percentage of medication reminders confirmed, from app logs.",{"measure":35,"description":36,"timeFrame":37},"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).","End of the 12-week intervention",{"measure":39,"description":40,"timeFrame":37},"Retention","Percentage of randomized participants in each group who complete the post-test assessment.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","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.\n\nDesign: two-arm, parallel-group randomized controlled trial with pretest and post-test measurement.\n\nRandomization: 60 participants are allocated 1:1 (30 per group) using a computer-generated sequence, with allocation concealed until baseline data collection is complete.\n\nIntervention: 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.\n\nAnalysis: 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.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"MoodSync Group","EXPERIMENTAL","MoodSync patient app and wearable device for 12 weeks, with optional caregiver app, in addition to standard care.",[55],"Behavioral: MoodSync",{"label":57,"type":58,"description":59,"interventionNames":60},"Standard Care Group","ACTIVE_COMPARATOR","Standard care at the participating mental health service.",[61],"Other: Standard care",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":41},"BEHAVIORAL","MoodSync","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.",[51],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":41},"Standard care","Participants continue routine psychiatric care, including clinic follow-up and prescribed medication, and complete the same assessments at baseline and post-test.",[57],[73],{"name":74,"affiliation":75,"role":76},"Rasha S Eweida","University of Bahrain","PRINCIPAL_INVESTIGATOR",[78,82],{"name":74,"role":79,"phone":80,"phoneExt":41,"email":81},"CONTACT","+973 37510883","rashapsych@alexu.edu.eg",{"name":83,"role":79,"phone":84,"phoneExt":41,"email":85},"Zohour I Rashwan","+973 35094573","zohour.rashwan@alexu.edu.eg",[87],{"facility":88,"status":41,"city":89,"state":41,"zip":41,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Psychiatric Hospital, Government Hospitals","Manama","Bahrain","BH",{"type":93,"coordinates":94},"Point",[95,96],50.58565,26.22787,{"lat":96,"lon":95},[99],{"name":100,"role":79,"phone":80,"phoneExt":41,"email":101},"Rasha Eweida","reweida@uob.edu.bh",{"type":76,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Rasha salah elsayed eweida","Assistant professor",[106],{"name":75,"class":6},"100660392","a-mobile-app-to-support-mood-daily-routines-and-medication-adherence-in-adults-with-severe-mental-illness-100660392",false,"NCT07879131","A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness","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","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* 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\n* Clinically stable, defined as no psychiatric hospital admission in the previous 3 months\n* Receiving care at a participating mental health service\n* Able to use a smartphone application\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Acute psychiatric crisis at the time of recruitment\n* Inability to provide informed consent\n* Severe cognitive impairment preventing use of the application\n* No access to a compatible mobile device, unless one is provided by the project\n\nFamily caregivers (intervention group, optional): adult family member nominated by the participant, who gives separate written informed consent.","ALL","18 Years",{"count":117,"type":118},60,"ESTIMATED","INTERVENTIONAL",[121],"NA","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?\n\nParticipants 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.\n\nResearch hypothesis:\n\n\\* 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.",[124,125,126,127,128],"Severe Mental Illness","Bipolar Disorder","Schizophrenia","Schizoaffective Disorder","Major Depressive Disorder",[130,131,132,133,134,135,136,137,138,90],"Mobile health (mHealth)","Smartphone application","Mood monitoring","Social rhythm","Medication adherence","Relapse prevention","Early warning signs","Wearable devices","Family caregivers","NOT_YET_RECRUITING","2026-10-10",{"date":142,"type":143},"2026-10-16","ACTUAL",{"date":145,"type":118},"2026-11",{"date":147,"type":118},"2027-11",{"name":5,"class":6},1]