Mental Health IssueNCT06320756
Examining the Feasibility of Wysa in Hindi
A study testing Wysa in Hindi and Individual and group sessions on topics like motivation, coping, wellbeing in people with Mental Health Issue and Diabetes Distress, run by Wysa at 1 site in India.
Trial summary
The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Mental Health Issue, Diabetes Distress
- What is being tested?
- Wysa in Hindi and Individual and group sessions on topics like motivation, coping, wellbeing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteIndia
- Study dates
- 23 Feb 2024to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 13-25 years
- Diagnosis of Type1 diabetes
- Access to a smartphone with internet connection
- Can read and understand Hindi
- Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)
Who cannot join
- Do not own or have access to a mobile device
- Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
- Are currently undergoing or have received psychiatric support
- Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of a Digital Mental Health Intervention (Wysa in Hindi) in Improving Mental Health Distress in Adolescents and Young Adults with Type 1 Diabetes in Low Resource Settings
The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: >2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17).
Read the detailed description
Participants (13-25 years) with Type1 Diabetes are invited into the study. The intervention being studied is the Wysa in Hindi app. Participants will be recruited from Udaan (a Non-Governmental Organization (NGO) supporting individuals with Type1 diabetes). They will complete baseline research procedures and be randomly allocated to one of two groups.
Participants in the intervention arm will get access to the Wysa in Hindi app as well as access to usual care (individual and group sessions on motivation, mental health, and coping). The control arm will only have access to the usual care i.e. the individual and group sessions. At the end of 2 months, participants will be invited for follow-up to complete the endline assessments.
- Conditions
- Mental Health Issue, Diabetes Distress
- Being tested
- Wysa in Hindi, Individual and group sessions on topics like motivation, coping, wellbeing
- Keywords
- digital mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wysa in HindiBehavioural
Wysa in Hindi is a blended digital mental health intervention
Individual and group sessions on topics like motivation, coping, wellbeingBehavioural
Individual and group sessions on wellbeing, coping, and motivation with the diabetes educator team
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: Wysa in Hindi + usual care | Experimental | The intervention arm will receive Wysa in Hindi and the usual care. Wysa in Hindi is a digital mental health intervention that combines Artificial Intelligence-led conversational chatbot support and human therapy in the Hindi language. The Artificial Intelligence (AI) chatbot acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT) techniques, written by qualified psychologists and clinicians.
Usual care includes access to individual and bi-weekly group sessions focused on building coping, wellbeing, and motivation by the diabetes educator team. Receives: Behavioral: Wysa in Hindi; Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing |
| Usual care arm | Active comparator | Participants in the control group will only have access to usual care (which will remain the same as that for the intervention arm). This includes access to individual sessions and bi-weekly group sessions with the diabetes education team on motivation, wellbeing, and coping. Receives: Behavioral: Individual and group sessions on topics like motivation, coping, wellbeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)
Proportion of participants who completed consent procedures versus those who were invited to participate in the study via awareness activities.
Measured: Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)
Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)
Proportion of recruited participants who completed endline assessments i.e. those who remained enrolled for the study duration.
Measured: Measured after the 2 month intervention during follow-up endline assessments
Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)
Proportion of recruited participants who interacted with Wysa at least once after onboarding to the app. Information will also collected on average numbers of days the app was used.
Measured: Measured at the end of the 2 month intervention
Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)
Proportion of recruited participants who completed at least one session with the therapist available on Wysa app.
Measured: Measured at the end of the 2 month intervention
Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app
Feedback is collected through 4 questions wherein 3 questions ask participants to provide a quantitative rating of the app features' usability and satisfaction. Participants can provide ratings on a 5 point likert scale with higher ratings denoting higher satisfaction. 1 qualitative question invites participant to use free text format to provide any additional feedback. All feedback is collected twice on the app i..e. Day 2 and Day 45 from onboarding.
Measured: This is collected twice; on day 2 and day 45 from onboarding on the app
Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app
Participants provide feedback about their app therapist sessions through 3 questions asking for a quantitative rating of their satisfaction, and 1 question where participant can provide a free text response with their overall feedback. The quantitative rating is on a 5 point Likert scale with higher ratings indicating higher satisfaction. Feedback will be collected at the end of each therapist session.
Measured: Collected post every therapist session during the intervention period of 2 months
Secondary outcomes (2)
Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)
PHQ-9, a 9 item self report scale will be to ask about the presence of depressive symptoms. Participants are asked to rate the frequency of symptoms on a scale of 0-3. It gives a score between 0-27, with higher scores indicating more severe symptoms.
Measured: Baseline assessment, and then at the 2 month follow-up endline assessment
Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)
Diabetes Distress Scale (DDS-17) is a 17 item self report questionnaire on diabetes distress. Participants have to respond to how much a problem has affected their lives on a scale of 1-6. The scoring yields a mean score range between 1-6, wherein higher scores indicate higher levels of distress.
Measured: Baseline assessment, and then at the 2 month follow up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start23 Feb 2024
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial with an intervention arm and a control arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wysa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Udaan
- Responsible party
- Sponsor
- Investigators
- Tejaswi Shetty, M.A., Principal investigator, Touchkin eServices Pvt. Ltd.Archana Sarda, M.D, Principal investigator, UdaanChaitali Sinha, M.A., Principal investigator, Touchkin eServices Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320756
- Sponsor's protocol ID
- 24-WYSA-101
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 24 Dec 2024
- 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.
Publications
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
PubMed 15735199
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Digital Mental Health Intervention (Wysa in Hindi) in Improving Mental Health Distress in Adolescents and Young Adults with Type 1 Diabetes in Low Resource Settings
- ClinicalTrials.gov ID
- NCT06320756
- Acronym / sponsor ID
- 24-WYSA-101
- Conditions
- Mental Health Issue, Diabetes Distress
- Keywords
- digital mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- WysaIndustry (pharma, biotech, devices)
- Collaborators
- Udaan
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 20 Mar 2024 (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 principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: >2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17).
Detailed description
Participants (13-25 years) with Type1 Diabetes are invited into the study. The intervention being studied is the Wysa in Hindi app. Participants will be recruited from Udaan (a Non-Governmental Organization (NGO) supporting individuals with Type1 diabetes). They will complete baseline research procedures and be randomly allocated to one of two groups.
Participants in the intervention arm will get access to the Wysa in Hindi app as well as access to usual care (individual and group sessions on motivation, mental health, and coping). The control arm will only have access to the usual care i.e. the individual and group sessions. At the end of 2 months, participants will be invited for follow-up to complete the endline assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial with an intervention arm and a control arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: Wysa in Hindi + usual care | Experimental | Behavioral: Wysa in Hindi, Behavioral: Individual and group sessions on topics like motivation, coping, wellbeingThe intervention arm will receive Wysa in Hindi and the usual care. Wysa in Hindi is a digital mental health intervention that combines Artificial Intelligence-led conversational chatbot support and human therapy in the Hindi language. The Artificial Intelligence (AI) chatbot acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT) techniques, written by qualified psychologists and clinicians. Usual care includes access to individual and bi-weekly group sessions focused on building coping, wellbeing, and motivation by the diabetes educator team. |
| Usual care arm | Active comparator | Behavioral: Individual and group sessions on topics like motivation, coping, wellbeingParticipants in the control group will only have access to usual care (which will remain the same as that for the intervention arm). This includes access to individual sessions and bi-weekly group sessions with the diabetes education team on motivation, wellbeing, and coping. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 13-25 years
- Diagnosis of Type1 diabetes
- Access to a smartphone with internet connection
- Can read and understand Hindi
- Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)
Key exclusion criteria (4 listed)
- Do not own or have access to a mobile device
- Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
- Are currently undergoing or have received psychiatric support
- Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention
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 |
|---|---|---|
| Wysa in HindiWysa in Hindi is a blended digital mental health intervention | Behavioural | Intervention arm: Wysa in Hindi + usual care |
| Individual and group sessions on topics like motivation, coping, wellbeingIndividual and group sessions on wellbeing, coping, and motivation with the diabetes educator team | Behavioural | Intervention arm: Wysa in Hindi + usual care, Usual care arm |
Primary outcome
Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)
Time frame: Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)
Proportion of participants who completed consent procedures versus those who were invited to participate in the study via awareness activities.
Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)
Time frame: Measured after the 2 month intervention during follow-up endline assessments
Proportion of recruited participants who completed endline assessments i.e. those who remained enrolled for the study duration.
Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)
Time frame: Measured at the end of the 2 month intervention
Proportion of recruited participants who interacted with Wysa at least once after onboarding to the app. Information will also collected on average numbers of days the app was used.
Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)
Time frame: Measured at the end of the 2 month intervention
Proportion of recruited participants who completed at least one session with the therapist available on Wysa app.
Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app
Time frame: This is collected twice; on day 2 and day 45 from onboarding on the app
Feedback is collected through 4 questions wherein 3 questions ask participants to provide a quantitative rating of the app features' usability and satisfaction. Participants can provide ratings on a 5 point likert scale with higher ratings denoting higher satisfaction. 1 qualitative question invites participant to use free text format to provide any additional feedback. All feedback is collected twice on the app i..e. Day 2 and Day 45 from onboarding.
Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app
Time frame: Collected post every therapist session during the intervention period of 2 months
Participants provide feedback about their app therapist sessions through 3 questions asking for a quantitative rating of their satisfaction, and 1 question where participant can provide a free text response with their overall feedback. The quantitative rating is on a 5 point Likert scale with higher ratings indicating higher satisfaction. Feedback will be collected at the end of each therapist session.
2 secondary outcomes
Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline assessment, and then at the 2 month follow-up endline assessment
Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)
Time frame: Baseline assessment, and then at the 2 month follow up assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 15735199Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
- 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. This study is not recruiting at the moment.
Tejaswi Shetty, M.A. principal investigator
Touchkin eServices Pvt. Ltd.
Archana Sarda, M.D principal investigator
Udaan
Chaitali Sinha, M.A. principal investigator
Touchkin eServices Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wysa in Hindi and Individual and group sessions on topics like motivation, coping, wellbeing in people with Mental Health Issue and Diabetes Distress, run by Wysa at 1 site in India.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment rate (Proportion of participants who completed consent procedures) (time frame: Measured at the end of the recruitment period (3 weeks, or if recruitment is extended at the end of 2 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320756, which also lists 2 linked publications.
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 24 Dec 2024.