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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 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

179

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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)

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

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 .

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).

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
List of Final Wysa Adaptations and Implementation strategies
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 maj 2026

Primärt slutförande (Beräknad)

1 september 2026

Avslutad studie (Beräknad)

1 november 2026

Studieregistreringsdatum

Först inskickad

12 maj 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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