Co-designing Adaptations of a Digital Mental Health Intervention (Wysa) for Adolescent Girls With Anxiety or Depression in Rural India
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorWysa
About this trial
The goal of this study is to culturally and contextually adapt Wysa, an evidence-based AI-powered digital mental health intervention (DMHI), for adolescent girls (ages 13-18) with symptoms of anxiety and/or depression in rural Uttar Pradesh, India.
More specifically, the aims of this study are to (i) explore key barriers and facilitators to adoption, engagement, and usability of a digital mental health intervention (Wysa) in this setting, and to (ii) co-design contextually appropriate app adaptations and implementation strategies in collaboration with adolescent girls, their parents/guardians, and community stakeholders. At the end of this study, we would have co-developed a roadmap of potential adaptations to Wysa with implementation strategies to iteratively test and develop during the next phases of the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Sex: girls
Marital status: Unmarried
Are between 13-18 years of age
Residing in the selected villages of Uttar Pradesh, India.
Disqualifiers
Adolescent girls who have difficulties that would prevent them from actively participating in workshop activities (e.g. with memory or comprehension, indications of psychoses)
Are currently or have been in the past a girl icon in the Milaan Foundation Girl Icon program
Inclusion Criteria
Are guardians or caregivers of a participating adolescent girl.
Trial population
The study will be conducted in the selected Community Development Blocks (CD Blocks), an administrative subdivision of districts, across the 5 districts of Bahraich, Barabanki, Hardoi, Lucknow, and Sitapur in Uttar Pradesh.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Digital psychosocial tool
BehavioralWysa is a digital psychosocial tool that provides AI conversational chatbot support. The conversational agent acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT), mindfulness, and motivational intervention. Users can learn different techniques and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress In Aim 1 study (which is part of larger 5 year project), participants will recieve the current version of the digital psychosocial tool to provide their feedback. It is not being used as an intervention in this Aim 1 study
Treatment groups
179 Participants
are divided into 4 treatment groupsGroup A: Community Stakeholders1 intervention
Group B: Parents/Guardians1 intervention
Group C: Adolescent Girls1 intervention
Group D: Decision Makers1 intervention
Trial outcomes
Primary outcomes
1
List of Final Wysa Adaptations and Implementation strategies
A finalized adaptation roadmap will be developed including changes to be made in Wysa and implementation strategies to be executed to impove Wysa access and use
Time frame
From enrollment until end of particpatory workshops at Month 6Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wysa
Lead sponsor
Wellcome Trust
Collaborator
Imperial College London
Collaborator
Tata Institute of Social Sciences
Collaborator
Milaan Foundation
Collaborator
Source ClinicalTrials.gov
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