Clinical trial NCT06801093: Evaluating the Impact of a Digital Psychosocial Tool (Wysa) on Life Skills and Well-being of College Students in India
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wellbeing
Resilience
Self Efficacy
Life Skills
Problem Solving
Keywords: digital psychosocial tool
wellbeing
life skills
college student
digital intervention
feasibility study
Lead sponsor: London School of Economics and Political Science
Sponsor class: OTHER
Collaborators: name: Wysa
First posted: 2025-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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. 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Recruitment rate
timeFrame: Measured during the recruitment period (1 month, or if recruitment is extended at the end of 2 months)
measure: Feasibility - Retention rate
timeFrame: Measured after the 2 month intervention during follow-up assessments
measure: Feasibility - App onboarding rate
timeFrame: Measured during the 2 month intervention period
measure: Acceptability - Wysa app engagement
timeFrame: Measured during the 2-month intervention period
measure: App satisfation
timeFrame: This is collected thrice during the 2-month intervention period
measure: App Acceptability and experiences of usage
timeFrame: Conducted after the intervention period (2 months)
Secondary outcomes:
measure: Changes in wellbeing as measured on the WHO Wellbeing Index
timeFrame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
measure: Changes in problem solving as measured on the Problem Solving Inventory
timeFrame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
measure: Changes in self-efficacy as measured on the general self-efficacy scale
timeFrame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
measure: Changes in resilience, as measured on the Brief Resilience Scale
timeFrame: 3 months: at Month 0 (pre-intervention), Month 2 (post-intervention period), Month 3 (1-month after intervention period)
Other outcomes:
Locations:
city: Palaj
country: India
facility: Indian Institute of Technology, Gandhinagar (IIT-Gandhinagar)
state: Gujarat
Study officials:
affiliation: London School of Economics and Political Science
name: Sarah Jasim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: