NCT06320756Completed
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 23 Feb 2024
- Start date
- 23 Feb 2024
- Primary completion date
- 28 May 2024
- Lead sponsor
- Wysa
- Diseases
- Type 1 diabetes
- NCT number
- NCT06320756
What you commit to
- Study type: Interventional
- Participants enrolled: 79
- From 23 Feb 2024 to the primary completion date, 28 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently undergoing or have received psychiatric support
Other
- Do not own or have access to a mobile device
- Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
- Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention
Who the study is looking for
- 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)
Age in the registry: 13 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Udaan Coordinator of this site? Confirm its status | Chhatrapati Sambhajinagar | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.