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).
Participants (13-25 years) with Type1 Diabetes are invited into the study. The intervention being studied is the Wysa in Hindi app. Participants will be recruited from Udaan (a Non-Governmental Organization (NGO) supporting individuals with Type1 diabetes). They will complete baseline research procedures and be randomly allocated to one of two groups. Participants in the intervention arm will get access to the Wysa in Hindi app as well as access to usual care (individual and group sessions on motivation, mental health, and coping). The control arm will only have access to the usual care i.e. the individual and group sessions. At the end of 2 months, participants will be invited for follow-up to complete the endline assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
79
Wysa in Hindi is a blended digital mental health intervention
Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team
Udaan
Aurangabad, Maharashtra, India
Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)
Proportion of participants who completed consent procedures versus those who were invited to participate in the study via awareness activities.
Time frame: Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)
Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)
Proportion of recruited participants who completed endline assessments i.e. those who remained enrolled for the study duration.
Time frame: Measured after the 2 month intervention during follow-up endline assessments
Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)
Proportion of recruited participants who interacted with Wysa at least once after onboarding to the app. Information will also collected on average numbers of days the app was used.
Time frame: Measured at the end of the 2 month intervention
Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)
Proportion of recruited participants who completed at least one session with the therapist available on Wysa app.
Time frame: Measured at the end of the 2 month intervention
Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app
Feedback is collected through 4 questions wherein 3 questions ask participants to provide a quantitative rating of the app features' usability and satisfaction. Participants can provide ratings on a 5 point likert scale with higher ratings denoting higher satisfaction. 1 qualitative question invites participant to use free text format to provide any additional feedback. All feedback is collected twice on the app i..e. Day 2 and Day 45 from onboarding.
Time frame: This is collected twice; on day 2 and day 45 from onboarding on the app
Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app
Participants provide feedback about their app therapist sessions through 3 questions asking for a quantitative rating of their satisfaction, and 1 question where participant can provide a free text response with their overall feedback. The quantitative rating is on a 5 point Likert scale with higher ratings indicating higher satisfaction. Feedback will be collected at the end of each therapist session.
Time frame: Collected post every therapist session during the intervention period of 2 months
Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)
PHQ-9, a 9 item self report scale will be to ask about the presence of depressive symptoms. Participants are asked to rate the frequency of symptoms on a scale of 0-3. It gives a score between 0-27, with higher scores indicating more severe symptoms.
Time frame: Baseline assessment, and then at the 2 month follow-up endline assessment
Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)
Diabetes Distress Scale (DDS-17) is a 17 item self report questionnaire on diabetes distress. Participants have to respond to how much a problem has affected their lives on a scale of 1-6. The scoring yields a mean score range between 1-6, wherein higher scores indicate higher levels of distress.
Time frame: Baseline assessment, and then at the 2 month follow up assessment
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