[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546025":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":60,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PST alone","ACTIVE_COMPARATOR","Patients randomized to PST alone will receive PST delivered using a stepped-care approach. Subsequent care will be determined based on participant PHQ-9 score at the week 6 evaluation. All participants who do not achieve remission (PHQ-9 \\\u003C12) after completion of the additional six-week therapy sessions, will be required to have a referral to either the general MD or psychiatrist at the clinic to determine need for pharmacologic treatment or additional intervention based on local clinical practice guidelines. During each PST session, the HIV counselor will ask the participant structured questions to identify those at risk of suicide, or with adverse reactions to prescribed antidepressants. Participants who indicate suicidality (plan\u002Fattempt) during PST sessions, or ongoing refractory disease (at reassessment points) will require immediate consultation by the psychiatry clinic.",[13],"Behavioral: Problem Solving Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"PST with Change My Story","EXPERIMENTAL","In addition to all activities described in the PST alone arm, at enrollment, participants in the arm with Change My Story, will download the game onto their phones, receive instructions about the game and receive recommendations on how to play the game (at least one narrative for one of the three characters) each week within 48 hours of the PST session. Participants will be encouraged to set a weekly reminder alarm for their game play session. Participants will have an opportunity to explore the game at will according to these loose parameters prior to the first PST session.",[13,19],"Other: Change My Story",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Problem Solving Therapy","Problem solving therapy (PST) is a cognitive-behavioral therapy (CBT)-based intervention that uses seven basic steps to teach problem solving orientation and skills to equip individuals to manage the impact of stressful life events on their mental health.",[9,15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Change My Story","Change My Story is a narrative game with a choose-your-own-adventure format in which players navigate emotionally difficult experiences along with the character(s) and interact with the virtual environment to choose a narrative path toward the story's conclusion. It will used to address important obstacles in the mental health treatment gap for Y-PLWH.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Aima a Ahonkhai, MD","CONTACT","617-726-3906","AAHONKHAI@mgh.harvard.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of Ibadan","RECRUITING","Ibadan","Oyo State","Nigeria","NG",{"type":46,"coordinates":47},"Point",[48,49],3.90591,7.37756,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Bibilola Oladeji, MBBS","234 02-2914-130","bibideji@yahoo.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Aimalohi Ahonkhai","Associate Physician in Medicine",[61],{"name":39,"class":6},"100546025","change-my-story-task-shifted-mental-health-intervention-100546025",false,"NCT06389565","Change My Story Task Shifted Mental Health Intervention","Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression","Inclusion Criteria:\n\n* HIV-positive\n* age 16-24 years\n* self-reported proficiency in reading and understanding English.\n* PHQ9 score of 8-17 and impairment in functioning (consistent with clinical depression)\n\nExclusion Criteria:\n\n* pregnant or nursing\n* in care and on ART for \\\u003C6 months\n* history of- or positive assessment for- bipolar or psychotic disorder.","ALL","16 Years","24 Years",{"count":73,"type":74},80,"ESTIMATED","INTERVENTIONAL",[77],"NA","Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.",[80,81,82],"Hiv","Depression","Psychological Distress","2026-05-26",{"date":85,"type":86},"2026-05-28","ACTUAL",{"date":88,"type":86},"2025-06-01",{"date":90,"type":74},"2026-06-30",{"name":5,"class":6},1]