AnxietyNCT07595029
Co-designing Adaptations of a Digital Mental Health Intervention (Wysa) for Adolescent Girls With Anxiety or Depression in Rural India
An observational study of Anxiety and Depression in Adolescence, run by Wysa.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression in Adolescence, Anxiety Disorder of Adolescence
- What is being tested?
- Digital psychosocial tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
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- 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:
- Inclusion Criteria
- Are guardians or caregivers of a participating adolescent girl.
- Currently reside in Uttar Pradesh
- Provide informed consent to participate.
- 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
- Inclusion criteria
- Contribute to and influence local health related-decisions or services.
- Provide informed consent to participate.
- 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)
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Digital psychosocial tool
- 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
- Medical subject headings
- Anxiety Disorders, Depression, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital psychosocial toolBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 . Receives: 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). Receives: Behavioral: Digital psychosocial tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment until end of particpatory workshops at Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wysa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust, Imperial College London, Tata Institute of Social Sciences, Milaan Foundation
- Responsible party
- Principal investigator, Chaitali Sinha, Wysa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595029
- Sponsor's protocol ID
- 26-WYSA-01
- Other IDs
- 321110/Z/24/Z
- Status last verified
- Apr 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with any external party as it does not comply with the terms of consent.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07595029
- Acronym / sponsor ID
- 26-WYSA-01
- Keywords
- Digital Mental Health, Adolescent Mental Health, Anxiety, Depression, Rural Population, India, Implementation Science, Patient Engagement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- WysaIndustry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust, Imperial College London, Tata Institute of Social Sciences, Milaan Foundation
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Community Stakeholders | – | Behavioral: Digital psychosocial toolCommunity 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) |
| Parents/Guardians | – | Behavioral: Digital psychosocial toolParents or guardians of adolescent girl participants across diverse caste, , religious, phone ownership, and ages will be included. Parents/ guardians of different genders will included |
| Adolescent Girls | – | Behavioral: Digital psychosocial toolAdolescent girl participants from diverse backgrounds such as age, caste, religion, geographical location, phone ownership, and literacy levels will be included . |
| Decision Makers | – | Behavioral: Digital psychosocial toolIndividuals who work at the district or state level, and in different areas of work that intersect with adolescent wellbeing (such as education, health etc). |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital psychosocial toolWysa 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 | Behavioural | Adolescent Girls, Community Stakeholders, Decision Makers, Parents/Guardians |
Primary outcome
List of Final Wysa Adaptations and Implementation strategies
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with any external party as it does not comply with the terms of consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression in Adolescence, run by Wysa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaitali Sinha (+16262368661, chaitali@wysa.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
List of Final Wysa Adaptations and Implementation strategies (time frame: From enrollment until end of particpatory workshops at Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.