NCT06801093

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed
Last Updated

June 25, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 17, 2025

Last Update Submit

June 20, 2025

Conditions

Keywords

digital psychosocial toolwellbeinglife skillscollege studentdigital interventionfeasibility study

Outcome Measures

Primary Outcomes (6)

  • Feasibility - Recruitment rate

    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

    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

    Proportion of participants who downloaded the app after allocation to the intervention

    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 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.

    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.

    Conducted after the intervention period (2 months)

Secondary Outcomes (4)

  • Changes in wellbeing as measured on the WHO Wellbeing Index

    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

    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

    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

    3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)

Study Arms (1)

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.

Behavioral: Digital psychosocial tool

Interventions

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.

Wysa app

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Institute of Technology, Gandhinagar (IIT-Gandhinagar)

Palaj, Gujarat, 382355, India

Location

Study Officials

  • Sarah Jasim, Ph.D

    London School of Economics and Political Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 30, 2025

Study Start

January 30, 2025

Primary Completion

June 4, 2025

Study Completion

June 4, 2025

Last Updated

June 25, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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

Locations