Evaluating the Impact of a Digital Psychosocial Tool (Wysa) on Life Skills and Well-being of College Students in India

June 20, 2025 updated by: Sarah Jasim, London School of Economics and Political Science

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:

  1. The feasibility and acceptability of Wysa amongst college students enrolled at the university
  2. The effectiveness of Wysa in improving the life skills and well-being of college students enrolled at the university

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Palaj, Gujarat, India, 382355
        • Indian Institute of Technology, Gandhinagar (IIT-Gandhinagar)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Have previously used Wysa app (the intervention)
  • Presence of self-harm/suicidal risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wysa app
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.
Behavioral: 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured during the recruitment period (1 month, or if recruitment is extended at the end of 2 months)
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.
Measured after the 2 month intervention during follow-up assessments
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
Measured during the 2 month intervention period
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.
Measured during the 2-month intervention period
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.
This is collected thrice during the 2-month intervention period
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.
Conducted after the intervention period (2 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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.
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)
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.
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)
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.
3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Economics and Political Science

Collaborators

Wysa

Investigators

  • Principal Investigator: Sarah Jasim, Ph.D, London School of Economics and Political Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

June 4, 2025

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 390706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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