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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

179

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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)
Verhalten: 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
Verhalten: 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 .
Verhalten: 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).
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
List of Final Wysa Adaptations and Implementation strategies
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wysa

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. September 2026

Studienabschluss (Geschätzt)

1. November 2026

Studienanmeldedaten

Zuerst eingereicht

12. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-WYSA-01
  • 321110/Z/24/Z (Andere Zuschuss-/Finanzierungsnummer: Wellcome Trust)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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