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Completed

NCT Number: NCT06320756

Examining the Feasibility of Wysa in Hindi

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).

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Key information

Conditions

Mental Health Issue Diabetes Distress

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Udaan

Aurangabad, Maharashtra, 431003, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 13-25 years
  • Diagnosis of Type1 diabetes
  • Access to a smartphone with internet connection
  • Can read and understand Hindi
  • Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)

Exclusion criteria

  • Do not own or have access to a mobile device
  • Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
  • Are currently undergoing or have received psychiatric support
  • Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention

Treatment and study plan

Wysa in Hindi

Behavioral

Wysa in Hindi is a blended digital mental health intervention

Individual and group sessions on topics like motivation, coping, wellbeing

Behavioral

Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team

Primary outcomes

  1. Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)

    Time frame: Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)

    Proportion of participants who completed consent procedures versus those who were invited to participate in the study via awareness activities.

  2. Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)

    Time frame: Measured after the 2 month intervention during follow-up endline assessments

    Proportion of recruited participants who completed endline assessments i.e. those who remained enrolled for the study duration.

  3. Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)

    Time frame: Measured at the end of the 2 month intervention

    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.

  4. Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)

    Time frame: Measured at the end of the 2 month intervention

    Proportion of recruited participants who completed at least one session with the therapist available on Wysa app.

  5. Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app

    Time frame: This is collected twice; on day 2 and day 45 from onboarding 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.

  6. Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app

    Time frame: Collected post every therapist session during the intervention period of 2 months

    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.

Secondary outcomes

  1. Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline assessment, and then at the 2 month follow-up endline assessment

    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.

  2. Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)

    Time frame: Baseline assessment, and then at the 2 month follow up assessment

    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.

Sponsors and collaborators

Lead sponsor

Wysa

Industry

Collaborators

  • Udaan

Registry information

Official study title

A Feasibility Study of a Digital Mental Health Intervention (Wysa in Hindi) in Improving Mental Health Distress in Adolescents and Young Adults with Type 1 Diabetes in Low Resource Settings

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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