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

12 mei 2026 bijgewerkt door: Chaitali Sinha, Wysa

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

179

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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. Exclusion Criteria ● They have difficulties that would prevent them from actively participating in workshop activities (e.g. with memory or comprehension, indications of psychoses).

COMMUNITY STAKEHOLDERS & DECISION MAKERS

  1. Inclusion criteria

    • Contribute to and influence local health related-decisions or services.
    • Provide informed consent to participate.
  2. Exclusion Criteria ● Stakeholders who have difficulties that would prevent them from actively participating in workshop activities (e.g. with memory or comprehension, indications of psychoses)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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)
Gedragsmatig: Digital psychosocial tool

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
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
Gedragsmatig: Digital psychosocial tool

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

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
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).
Gedragsmatig: Digital psychosocial tool

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
List of Final Wysa Adaptations and Implementation strategies
Tijdsspanne: From enrollment until end of particpatory workshops at Month 6
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wysa

Medewerkers

Imperial College London
Wellcome Trust
Tata Institute of Social Sciences
Milaan Foundation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

12 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26-WYSA-01
  • 321110/Z/24/Z (Ander subsidie-/financieringsnummer: Wellcome Trust)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared with any external party as it does not comply with the terms of consent.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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