Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320756
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-23
Brief Title:
Examining the Feasibility of Wysa in Hindi
Sponsor:
Wysa
Organization:
Wysa
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 20 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 ie the individual and group sessions At the end of 2 months participants will be invited for follow-up to complete the endline assessments
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 ie the individual and group sessions At the end of 2 months participants will be invited for follow-up to complete the endline assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None