Clinical trial NCT05500209: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change on Perceived Stress Scale 4 (PSS-4)
timeFrame: Change from baseline on PSS-4 (7 days)
measure: Change on Perceived Stress Scale 4 (PSS-4)
timeFrame: Change from baseline on PSS-4 (1 month)
measure: Change on Perceived Stress Scale 4 (PSS-4)
timeFrame: Change from baseline on PSS-4 (6 month)
measure: Change on Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline on BBQ (7 days)
measure: Change on Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline on BBQ (1 month)
measure: Change on Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline on BBQ (6 months)
Secondary outcomes:
measure: Coping Self-Efficacy Scale (CSES)
timeFrame: Change from baseline on CSES (7 days)
measure: Coping Self-Efficacy Scale (CSES)
timeFrame: Change from baseline on CSES (1 month)
measure: Coping Self-Efficacy Scale (CSES)
timeFrame: Change from baseline on CSES (6 months)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: SWPS University of Social Sciences and Humanities
Study officials:
affiliation: 1Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland
name: Ewelina Smoktunowicz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.