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

Sponsor
University of Social Sciences and Humanities, Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT05500209
Collaborator
(none)
300
1
2
8
37.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personal resources' enhancement: self-efficacy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Chatbot-based Internet Intervention for Stress Among University Students: A Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change on Perceived Stress Scale 4 (PSS-4) [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.

  2. Change on Perceived Stress Scale 4 (PSS-4) [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.

  3. Change on Perceived Stress Scale 4 (PSS-4) [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.

  4. Change on Brunnsviken Brief Quality of Life Scale (BBQ) [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.

  5. Change on Brunnsviken Brief Quality of Life Scale (BBQ) [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.

  6. Change on Brunnsviken Brief Quality of Life Scale (BBQ) [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.

Secondary Outcome Measures

  1. Coping Self-Efficacy Scale (CSES) [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.

  2. Coping Self-Efficacy Scale (CSES) [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.

  3. Coping Self-Efficacy Scale (CSES) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SWPS University of Social Sciences and Humanities Warsaw Poland 00-864

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ewelina Smoktunowicz, Principal Investigator, University of Social Sciences and Humanities, Warsaw
ClinicalTrials.gov Identifier:
NCT05500209
Other Study ID Numbers:
  • Stressbot
First Posted:
Aug 15, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022