Chatbot-based Internet Intervention for Stress Among University Students (Stressbot)

August 22, 2022 updated by: Ewelina Smoktunowicz, University of Social Sciences and Humanities, Warsaw

Efficacy of Chatbot-based Internet Intervention for Stress Among University Students: A Randomized Controlled Trial

The aim of this study is to verify the efficacy of chatbot internet intervention for reduction of stress and improvement of quality of life among university students through the enhancement of coping self-efficacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

University students experience high stress levels and mental health risks. Research shows that increasing resources such as coping self-efficacy can reduce stress. Internet interventions can be successfully employed to deliver programs for improving university students' mental health.

The primary objective of this randomized controlled trial is to evaluate short- and long-term efficacy of coping self-efficacy enhancing intervention in reducing university students' stress and improving quality of life. The intervention will be delivered through a Facebook Messenger chat-bot. The secondary goal is to investigate acceptability of a chat-bot delivered intervention.

Participants will be recruited via social media and randomized to 1 of 2 groups: (1) experimental condition increasing coping self-efficacy with a 7-day program delivered through a chat-bot, or (2) waitlist control group. Outcomes include perceived stress and quality of life. Measurements will be taken at baseline (T1), immediately after intervention (T2), at 1 month follow-up (T3), and at 6 months follow-up (T4). Linear mixed effects model will be used to analyze the data.

The study aims to assess Stressbot's potential benefit for improving university students' well-being. Moreover, it will provide insight into feasibility of using chat-bots for delivering smartphone-based e-health treatments.

Study Type

Interventional

Enrollment (Anticipated)

300

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 Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 00-864
        • Recruiting
        • SWPS University of Social Sciences and Humanities
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of at least 18 years
  • University students
  • Mobile personal device with internet access

Exclusion Criteria:

  • Not meeting at least 1 inclusion criteria

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coping Self-Efficacy
Experimental condition enhancing coping self-efficacy
Behavioral: Personal resources' enhancement: self-efficacy
Participants in this condition are asked to take part in a 7-day psychological intervention delivered through Facebook Messenger chat-bot. Each day one CBT-framed exercise aimed at coping self-efficacy enhancement is delivered. An exercise takes form 5 to 30 minutes to complete.
No Intervention: Waitlist control
Waitlist control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Perceived Stress Scale 4 (PSS-4)
Time Frame: Change from baseline on PSS-4 (7 days)
The PSS-4 is a measure of perceived stress. It consists of 4 items with response scale from 0 to 4. Higher total score represents higher perceived stress.
Change from baseline on PSS-4 (7 days)
Change on Perceived Stress Scale 4 (PSS-4)
Time Frame: Change from baseline on PSS-4 (1 month)
The PSS-4 is a measure of perceived stress. It consists of 4 items with response scale from 0 to 4. Higher total score represents higher perceived stress.
Change from baseline on PSS-4 (1 month)
Change on Perceived Stress Scale 4 (PSS-4)
Time Frame: Change from baseline on PSS-4 (6 month)
The PSS-4 is a measure of perceived stress. It consists of 4 items with response scale from 1 to 4. Higher total score represents higher perceived stress.
Change from baseline on PSS-4 (6 month)
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline on BBQ (7 days)
The BBQ is a measure of quality of life. It consists of 12 items with response scale from 0 to 4. Higher total score represents higher quality of life.
Change from baseline on BBQ (7 days)
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline on BBQ (1 month)
The BBQ is a measure of quality of life. It consists of 12 items with response scale from 0 to 4. Higher total score represents higher quality of life.
Change from baseline on BBQ (1 month)
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline on BBQ (6 months)
The BBQ is a measure of quality of life. It consists of 12 items with response scale from 0 to 4. Higher total score represents higher quality of life.
Change from baseline on BBQ (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping Self-Efficacy Scale (CSES)
Time Frame: Change from baseline on CSES (7 days)
The CSES is a measure of coping self-efficacy. It consists of 26 items with response scale from 1 to 10. Higher total score represents higher coping self-efficacy.
Change from baseline on CSES (7 days)
Coping Self-Efficacy Scale (CSES)
Time Frame: Change from baseline on CSES (1 month)
The CSES is a measure of coping self-efficacy. It consists of 26 items with response scale from 1 to 10. Higher total score represents higher coping self-efficacy.
Change from baseline on CSES (1 month)
Coping Self-Efficacy Scale (CSES)
Time Frame: Change from baseline on CSES (6 months)
The CSES is a measure of coping self-efficacy. It consists of 26 items with response scale from 1 to 10. Higher total score represents higher coping self-efficacy.
Change from baseline on CSES (6 months)

Collaborators and Investigators

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

Sponsor

University of Social Sciences and Humanities, Warsaw

Investigators

  • Principal Investigator: Ewelina Smoktunowicz, PhD, 1Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stressbot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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