Skip to content

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

Identifying Barriers and Enablers to Co-Design Adaptations of a Digital Mental Health Intervention (Wysa) for Adolescent Girls in Low Resource Settings in Uttar Pradesh, India

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07595029
Enrollment
179
Registered
2026-05-19
Start date
2026-05-01
Completion date
2026-11-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Anxiety Disorder of Adolescence, Depression in 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

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.

Detailed description

STUDY OBJECTIVES Primary Objective: To develop a stakeholder-endorsed roadmap of Wysa app adaptations and implementation strategies to guide the next phases of the project, ensuring that Wysa is accessible, culturally appropriate, and responsive to the needs of adolescent girls in rural Uttar Pradesh, India. METHODS Recruitment Procedures: The study will be conducted across the 5 districts of Bahraich, Barabanki, Hardoi, Lucknow, and Sitapur in Uttar Pradesh. One-on-one or group Awareness sessions will be conducted in Hindi and/or English (based on their preference) to recruit community stakeholders, adolescent girls, and parents/ guardians in each district. All communication will be age-appropriate and emphasize voluntary participation and confidentiality. The goal of the awareness activities is to build culturally relevant mental health understanding, provide clear study information for informed participation, and allow individuals to reflect on their experiences and interests. Study Activities: This study is a sequential study with 122-179 participants and will be conducted in 3 phases. Quota-based purposive sampling will be utilized to select adolescent girls in each district (N=60-90). Further, parents/ guardians of participating adolescents in each district (N=35-50), key community stakeholders in each district (N=25-35); and 2-4 decision makers will be selected using a targeting purposive sampling criteria. Data collection methods include participatory co-design focus group workshops and supplementary interviews, rapid ethnography, and Delphi surveys. All selected participants will receive access to versions of Wysa to try out before the participatory workshops begin. Participatory workshops will be conducted seperately with adolescent girls, parents/ guardians of adolescent girl participants, and key community stakeholders to identify the barriers and enablers to adoption and engagement of Wysa app. Additionally, semi-structured individual interviews with a subset of adolescent girl participants will be conducted to further explore their in-depth perspectives. Next, Two rounds of Delphi surveys will be conducted in a participatory workshop a mixed-group of purposively sampled participants to prioritise and rate the identified barriers that have emerged from the previous phase of the participatory workshops and corresponding strategies against the APEASE criteria. Lastly, a final adaptation roadmap of key barriers to address and solutions to implement will be developed in a participatory workshop with a purposively sampled mixed sub-group of 18-24 participants.

Interventions

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

Sponsors

Wysa
Lead SponsorINDUSTRY
Wellcome Trust
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
Tata Institute of Social Sciences
CollaboratorOTHER
Milaan Foundation
CollaboratorUNKNOWN

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

ADOLESCENTS: Inclusion Criteria: * 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. Adolescents

Exclusion criteria

* 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: 1. Inclusion Criteria * Are guardians or caregivers of a participating adolescent girl. * Currently reside in Uttar Pradesh * Provide informed consent to participate. 2.

Design outcomes

Primary

MeasureTime frameDescription
List of Final Wysa Adaptations and Implementation strategiesFrom enrollment until end of particpatory workshops at Month 6A 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

Contacts

CONTACTChaitali Sinha
chaitali@wysa.io+16262368661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026