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

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Personal resources' enhancement: self-efficacy
Sponsored by
University of Social Sciences and Humanities, Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SWPS University of Social Sciences and Humanities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coping Self-Efficacy

Waitlist control

Arm Description

Experimental condition enhancing coping self-efficacy

Waitlist control condition

Outcomes

Primary Outcome Measures

Change on Perceived Stress Scale 4 (PSS-4)
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 on Perceived Stress Scale 4 (PSS-4)
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 on Perceived Stress Scale 4 (PSS-4)
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 on Brunnsviken Brief Quality of Life Scale (BBQ)
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 on Brunnsviken Brief Quality of Life Scale (BBQ)
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 on Brunnsviken Brief Quality of Life Scale (BBQ)
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

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

Full Information

First Posted
August 11, 2022
Last Updated
January 31, 2023
Sponsor
University of Social Sciences and Humanities, Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05500209
Brief Title
Chatbot-based Internet Intervention for Stress Among University Students (Stressbot)
Official Title
Efficacy of Chatbot-based Internet Intervention for Stress Among University Students: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
November 13, 2022 (Actual)
Study Completion Date
November 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Social Sciences and Humanities, Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coping Self-Efficacy
Arm Type
Experimental
Arm Description
Experimental condition enhancing coping self-efficacy
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Waitlist control condition
Intervention Type
Behavioral
Intervention Name(s)
Personal resources' enhancement: self-efficacy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on Perceived Stress Scale 4 (PSS-4)
Description
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.
Time Frame
Change from baseline on PSS-4 (7 days)
Title
Change on Perceived Stress Scale 4 (PSS-4)
Description
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.
Time Frame
Change from baseline on PSS-4 (1 month)
Title
Change on Perceived Stress Scale 4 (PSS-4)
Description
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.
Time Frame
Change from baseline on PSS-4 (6 month)
Title
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Description
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.
Time Frame
Change from baseline on BBQ (7 days)
Title
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Description
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.
Time Frame
Change from baseline on BBQ (1 month)
Title
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Description
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.
Time Frame
Change from baseline on BBQ (6 months)
Secondary Outcome Measure Information:
Title
Coping Self-Efficacy Scale (CSES)
Description
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.
Time Frame
Change from baseline on CSES (7 days)
Title
Coping Self-Efficacy Scale (CSES)
Description
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.
Time Frame
Change from baseline on CSES (1 month)
Title
Coping Self-Efficacy Scale (CSES)
Description
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.
Time Frame
Change from baseline on CSES (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewelina Smoktunowicz, PhD
Organizational Affiliation
1Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
SWPS University of Social Sciences and Humanities
City
Warsaw
ZIP/Postal Code
00-864
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30125790
Citation
Bakker D, Kazantzis N, Rickwood D, Rickard N. A randomized controlled trial of three smartphone apps for enhancing public mental health. Behav Res Ther. 2018 Oct;109:75-83. doi: 10.1016/j.brat.2018.08.003. Epub 2018 Aug 11.
Results Reference
background
PubMed Identifier
2648906
Citation
Hobfoll SE. Conservation of resources. A new attempt at conceptualizing stress. Am Psychol. 1989 Mar;44(3):513-24. doi: 10.1037//0003-066x.44.3.513.
Results Reference
background
PubMed Identifier
35242591
Citation
Amanvermez Y, Zhao R, Cuijpers P, de Wit LM, Ebert DD, Kessler RC, Bruffaerts R, Karyotaki E. Effects of self-guided stress management interventions in college students: A systematic review and meta-analysis. Internet Interv. 2022 Feb 12;28:100503. doi: 10.1016/j.invent.2022.100503. eCollection 2022 Apr.
Results Reference
background
PubMed Identifier
33427674
Citation
Smoktunowicz E, Lesnierowska M, Carlbring P, Andersson G, Cieslak R. Resource-Based Internet Intervention (Med-Stress) to Improve Well-Being Among Medical Professionals: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 11;23(1):e21445. doi: 10.2196/21445.
Results Reference
background

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

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