NCT06320756

Examining the Feasibility of Wysa in Hindi

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Wysa · Industry
• Sex: All
• Age: 13 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Mental Health Issue
• Diabetes Distress

Interventions

Type	Name	Description
BEHAVIORAL	Wysa in Hindi	Wysa in Hindi is a blended digital mental health intervention
BEHAVIORAL	Individual and group sessions on topics like motivation, coping, wellbeing	Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team

Timeline

• Start date: 2024-02-23
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2024-03-20
• Last updated: 2024-12-24

Locations

1 site across 1 country: India