protocolSection identificationModule nctId: NCT06320756, orgStudyIdInfo id: 24-WYSA-101, briefTitle: Examining the Feasibility of Wysa in Hindi, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Wysa, class: INDUSTRY, collaborators name: Udaan, descriptionModule briefSummary: The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17)., conditionsModule conditions: Mental Health Issue, conditions: Diabetes Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial with an intervention arm and a control arm., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: Wysa in Hindi, interventions name: Individual and group sessions on topics like motivation, coping, wellbeing, outcomesModule primaryOutcomes measure: Feasibility - Recruitment rate (Proportion of participants who completed consent procedures), primaryOutcomes measure: Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration), primaryOutcomes measure: Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app), primaryOutcomes measure: Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app), primaryOutcomes measure: Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app, primaryOutcomes measure: Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app, secondaryOutcomes measure: Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17), eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Udaan, status: RECRUITING, city: Aurangabad, state: Maharashtra, zip: 431003, country: India, contacts name: Archana Sarda, M.D, role: CONTACT, phone: 9730792405, email: dr.archana.sarda@gmail.com, contacts name: Saumya Sarda, B.A, role: CONTACT, phone: 8698351351, geoPoint lat: 19.87757, lon: 75.34226, hasResults: False