WellbeingNCT06801093
Evaluating the Impact of a Digital Psychosocial Tool (Wysa) on Life Skills and Well-being of College Students in India
A study testing Digital psychosocial tool in people with Wellbeing and Resilience, run by London School of Economics and Political Science at 1 site in India.
Trial summary
The goal of this study is to learn the feasibility of a digital psychosocial tool (Wysa) in improving life skills and overall wellbeing of English-speaking college students in IIT-Gandhinagar, a university in India. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellbeing, Resilience, Self Efficacy
- What is being tested?
- Digital psychosocial tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jan 2025to 4 Jun 2025
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are between 18-25 years of age
- Are a student of Idian Institute of Technology, Gandhinagar (IIT Gandhinagar)
- Are able to read and understand English
- Have access to an internet enabled smartphone
Who cannot join
- Have previously used Wysa app (the intervention)
- Presence of self-harm/suicidal risk
Trial locations and contacts
1 site in 1 country.
India1 site
Indian Institute of Technology, Gandhinagar (IIT-Gandhinagar)
Palaj, Gujarat, 382355
About this study
Official title: Evaluating the Impact of a Digital Psychosocial Tool (Wysa) on Life Skills and Overall Well-being With English-Speaking College Students in Gandhinagar, India: A Mixed Methods Feasibility Study
The goal of this study is to learn the feasibility of a digital psychosocial tool (Wysa) in improving life skills and overall wellbeing of English-speaking college students in IIT-Gandhinagar, a university in India. This will be conducted using pre-post assessments examining resilience, self-efficacy, problem solving, and wellbeing as well as examining app usage during the intervention period. The main questions it aims to answer are:
- The feasibility and acceptability of Wysa amongst college students enrolled at the university
- The effectiveness of Wysa in improving the life skills and well-being of college students enrolled at the university
Read the detailed description
This study will employ a mixed methods pre-post design to examine whether a digital psychosocial tool can help college students in India learn ways to manage their problems and improve their wellbeing. Students enrolled at the Indian Institute of Technology, Gandhinagar (IIT-Gn) and are interested in learning skills to manage stressors are invited to participate in the study. The intervention being studied is the Wysa app which includes an AI-based chatbot, a library of toolpacks , and SOS resources. Participants will complete baseline research procedures (T0) and be able to download the app. Participants can use the Wysa app for a period of 2 months. At the end of 2 months, participants will be invited to complete their endline assessments (T1). Another follow-up assessment (T2) will be carried out 1 month after the intervention period completion. A sub-sample of participants will be invited to participate in qualitative interviews to provide feedback about their experiences using the Wysa app and to understand the barriers and facilitators to acceptability and effectiveness of the app.
- Conditions
- Wellbeing, Resilience, Self Efficacy, Life Skills, Problem Solving
- Being tested
- Digital psychosocial tool
- Keywords
- digital psychosocial tool, wellbeing, life skills, college student, digital intervention, feasibility study
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. Participants can progressively work through learning different skills and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress.
| Study group | Role | What they receive |
|---|---|---|
| Wysa app | Experimental | Participants will receive the digital psychosocial tool (Wysa) for a period of 2 months. Wysa is a digital app that includes an AI-based conversational conversational agent, a repository of self-help tools, and SOS resources. Receives: Behavioral: Digital psychosocial tool |
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
Measured: Measured during the recruitment period (1 month, or if recruitment is extended at the end of 2 months)
Feasibility - Retention rate
Proportion of recruited participants who completed endline assessments and follow-up assessments i.e. those who remained enrolled for the study duration.
Measured: Measured after the 2 month intervention during follow-up assessments
Feasibility - App onboarding rate
Proportion of participants who downloaded the app after allocation to the intervention
Measured: Measured during the 2 month intervention period
Acceptability - Wysa app engagement
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. Analysis of usage of different app features and tools will also be conducted.
Measured: Measured during the 2-month intervention period
App satisfation
Feedback is collected through questions which 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.
Measured: This is collected thrice during the 2-month intervention period
App Acceptability and experiences of usage
Semi-structured interviews with a sub-sample of participants will provide insights into the lived experience of using the intervention; and barriers and facilitators to usage.
Measured: Conducted after the intervention period (2 months)
Secondary outcomes (4)
Changes in wellbeing as measured on the WHO Wellbeing Index
The WHO Wellbeing Index is a 5-item questionnaire assessing an individual's wellbeing. Participants can respond to how frequently they have felt the item asked on a 6-point likert scale. Scores range from 0-25
Measured: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Changes in problem solving as measured on the Problem Solving Inventory
The Problem Solving Inventory (PSI) is a 35-item scale. Participants can provide a rating of their problem solving skills on a 6-point likert scale from strongly agree to strongly disagree. The scale provides a score range from 35-210.
Measured: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Changes in self-efficacy as measured on the general self-efficacy scale
The General Self-Efficacy Scale is a 10-item scale. Participants can rate their self-efficacy on a 4-point likert scale ranging from 'not at all true' to 'exactly true'. The scale provides a score range between 10-40.
Measured: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Changes in resilience, as measured on the Brief Resilience Scale
The Brief Resilience Scale (BRS) includes 6 items and assesses an individual's ability to bounce back from stressors. Scores on each item range from 1-5 for with all six items giving a range from 6-30.
Measured: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start30 Jan 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellbeingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- Wysa
- Responsible party
- Principal investigator, Sarah Jasim, London School of Economics and Political Science
- Investigators
- Sarah Jasim, Ph.D, Principal investigator, London School of Economics and Political Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801093
- Sponsor's protocol ID
- 390706
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Digital Psychosocial Tool (Wysa) on Life Skills and Overall Well-being With English-Speaking College Students in Gandhinagar, India: A Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT06801093
- Acronym / sponsor ID
- 390706
- Conditions
- Wellbeing, Resilience, Self Efficacy, Life Skills, Problem Solving
- Keywords
- digital psychosocial tool, wellbeing, life skills, college student, digital intervention, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- Wysa
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 30 Jan 2025 (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 learn the feasibility of a digital psychosocial tool (Wysa) in improving life skills and overall wellbeing of English-speaking college students in IIT-Gandhinagar, a university in India. This will be conducted using pre-post assessments examining resilience, self-efficacy, problem solving, and wellbeing as well as examining app usage during the intervention period. The main questions it aims to answer are:
- The feasibility and acceptability of Wysa amongst college students enrolled at the university
- The effectiveness of Wysa in improving the life skills and well-being of college students enrolled at the university
Detailed description
This study will employ a mixed methods pre-post design to examine whether a digital psychosocial tool can help college students in India learn ways to manage their problems and improve their wellbeing. Students enrolled at the Indian Institute of Technology, Gandhinagar (IIT-Gn) and are interested in learning skills to manage stressors are invited to participate in the study. The intervention being studied is the Wysa app which includes an AI-based chatbot, a library of toolpacks , and SOS resources. Participants will complete baseline research procedures (T0) and be able to download the app. Participants can use the Wysa app for a period of 2 months. At the end of 2 months, participants will be invited to complete their endline assessments (T1). Another follow-up assessment (T2) will be carried out 1 month after the intervention period completion. A sub-sample of participants will be invited to participate in qualitative interviews to provide feedback about their experiences using the Wysa app and to understand the barriers and facilitators to acceptability and effectiveness of the app.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wysa app | Experimental | Behavioral: Digital psychosocial toolParticipants will receive the digital psychosocial tool (Wysa) for a period of 2 months. Wysa is a digital app that includes an AI-based conversational conversational agent, a repository of self-help tools, and SOS resources. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are between 18-25 years of age
- Are a student of Idian Institute of Technology, Gandhinagar (IIT Gandhinagar)
- Are able to read and understand English
- Have access to an internet enabled smartphone
Key exclusion criteria (2 listed)
- Have previously used Wysa app (the intervention)
- Presence of self-harm/suicidal risk
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. Participants can progressively work through learning different skills and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress. | Behavioural | Wysa app |
Primary outcome
Feasibility - Recruitment rate
Time frame: Measured during the recruitment period (1 month, or if recruitment is extended at the end of 2 months)
Proportion of participants who completed consent procedures
Feasibility - Retention rate
Time frame: Measured after the 2 month intervention during follow-up assessments
Proportion of recruited participants who completed endline assessments and follow-up assessments i.e. those who remained enrolled for the study duration.
Feasibility - App onboarding rate
Time frame: Measured during the 2 month intervention period
Proportion of participants who downloaded the app after allocation to the intervention
Acceptability - Wysa app engagement
Time frame: Measured during the 2-month intervention period
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. Analysis of usage of different app features and tools will also be conducted.
App satisfation
Time frame: This is collected thrice during the 2-month intervention period
Feedback is collected through questions which 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.
App Acceptability and experiences of usage
Time frame: Conducted after the intervention period (2 months)
Semi-structured interviews with a sub-sample of participants will provide insights into the lived experience of using the intervention; and barriers and facilitators to usage.
4 secondary outcomes
Changes in wellbeing as measured on the WHO Wellbeing Index
Time frame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Changes in problem solving as measured on the Problem Solving Inventory
Time frame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Changes in self-efficacy as measured on the general self-efficacy scale
Time frame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Changes in resilience, as measured on the Brief Resilience Scale
Time frame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
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 25 Jun 2025.
- 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.
Sarah Jasim, Ph.D principal investigator
London School of Economics and Political Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital psychosocial tool in people with Wellbeing and Resilience, run by London School of Economics and Political Science 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 4 inclusion and 2 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 25 Jun 2025. 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 (time frame: Measured during the recruitment period (1 month, 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?
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 25 Jun 2025.