Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2024-02-23
2024-05-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Intervention arm: Wysa in Hindi + usual care
The intervention arm will receive Wysa in Hindi and the usual care. Wysa in Hindi is a digital mental health intervention that combines Artificial Intelligence-led conversational chatbot support and human therapy in the Hindi language. The Artificial Intelligence (AI) chatbot acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT) techniques, written by qualified psychologists and clinicians.
Usual care includes access to individual and bi-weekly group sessions focused on building coping, wellbeing, and motivation by the diabetes educator team.
Individual and group sessions on topics like motivation, coping, wellbeing
Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team
Wysa in Hindi
Wysa in Hindi is a blended digital mental health intervention
Usual care arm
Participants in the control group will only have access to usual care (which will remain the same as that for the intervention arm). This includes access to individual sessions and bi-weekly group sessions with the diabetes education team on motivation, wellbeing, and coping.
Individual and group sessions on topics like motivation, coping, wellbeing
Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team
Interventions
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Individual and group sessions on topics like motivation, coping, wellbeing
Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team
Wysa in Hindi
Wysa in Hindi is a blended digital mental health intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
13 Years
25 Years
ALL
No
Sponsors
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Udaan
UNKNOWN
Wysa
INDUSTRY
Responsible Party
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Principal Investigators
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Tejaswi Shetty, M.A.
Role: PRINCIPAL_INVESTIGATOR
Touchkin eServices Pvt. Ltd.
Archana Sarda, M.D
Role: PRINCIPAL_INVESTIGATOR
Udaan
Chaitali Sinha, M.A.
Role: PRINCIPAL_INVESTIGATOR
Touchkin eServices Pvt. Ltd.
Locations
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Udaan
Aurangabad, Maharashtra, India
Countries
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References
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Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
Other Identifiers
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24-WYSA-101
Identifier Type: -
Identifier Source: org_study_id