Co-designing Adaptations of a Digital Mental Health Intervention (Wysa) for Adolescent Girls With Anxiety or Depression in Rural India

NCT07595029 | Not Yet Recruiting

• 2 other identifiers: 26-WYSA-01321110/Z/24/Z
• Study Type: observational
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety; Depression in Adolescence; Anxiety Disorder of Adolescence

Keywords

Digital Mental Health; Adolescent Mental Health; Anxiety; Depression; Rural Population; India; Implementation Science; Patient Engagement; Early Intervention, Psychological; Chatbot; Low-Resource Settings; Adolescent Girls; Artificial Intelligence; Cultural Adaptation; Cognitive Behavioural Therapy; Wysa; Mental Health Access

Outcome Measures

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

  From enrollment until end of particpatory workshops at Month 6

Study Arms (4)

Community Stakeholders

Community stakeholders will be strategically sampled to capture different areas of work art a village level that intersect or impact with adolescent well being including: * Community leaders (e.g. panchayat, district and/or state officials) * Individuals providing well-being or mental health services * Local health workers (e.g. ASHAs, ANMs, Community Health \& Sanitation Committee representatives) * NGO representatives in adolescent programmes * School staff (e.g. teacher, principal)

Behavioral: Digital psychosocial tool

Parents/Guardians

Parents or guardians of adolescent girl participants across diverse caste, , religious, phone ownership, and ages will be included. Parents/ guardians of different genders will included

Behavioral: Digital psychosocial tool

Adolescent Girls

Adolescent girl participants from diverse backgrounds such as age, caste, religion, geographical location, phone ownership, and literacy levels will be included .

Behavioral: Digital psychosocial tool

Decision Makers

Individuals who work at the district or state level, and in different areas of work that intersect with adolescent wellbeing (such as education, health etc).

Behavioral: Digital psychosocial tool

Interventions

Digital psychosocial tool BEHAVIORAL

Wysa 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

Adolescent Girls; Community Stakeholders; Decision Makers; Parents/Guardians

Eligibility Criteria

• Age: 13 Years+
• Gender Eligibility Details: For the adolescent girls cohort specifically, we are only including females. For all other cohorts (parents/ guardians, community stakeholders or decision makers there is no gender based eligibility
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Sex: girls
• Marital status: Unmarried
• Are between 13-18 years of age
• Residing in the selected villages of Uttar Pradesh, India.
• Have elevated anxiety and/or depressive symptoms on the RCADS-25.
• Have access to a mobile phone (at least 1 mobile phone within the family).
• Provide assent/ consent to participate, along with guardian consent for minors.

You may not qualify if:

• 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
• PARENTS/GUARDIANS:
• Are guardians or caregivers of a participating adolescent girl.
• Currently reside in Uttar Pradesh
• Provide informed consent to participate.
• COMMUNITY STAKEHOLDERS \& DECISION MAKERS
• Contribute to and influence local health related-decisions or services.
• Provide informed consent to participate.

Sponsors & Collaborators

• Wysa: lead
• Wellcome Trust: collaborator
• Imperial College London: collaborator
• Tata Institute of Social Sciences: collaborator
• Milaan Foundation: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Depression; Patient Participation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Chaitali Sinha

CONTACT

+16262368661; chaitali@wysa.io

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical R&D Officer

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share