NCT05500209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

August 11, 2022

Last Update Submit

January 31, 2023

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (6)

  • 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 from baseline on PSS-4 (7 days)

  • 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 from baseline on PSS-4 (1 month)

  • 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 from baseline on PSS-4 (6 month)

  • 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 from baseline on BBQ (7 days)

  • 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 from baseline on BBQ (1 month)

  • 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 from baseline on BBQ (6 months)

Secondary Outcomes (3)

  • Coping Self-Efficacy Scale (CSES)

    Change from baseline on CSES (7 days)

  • Coping Self-Efficacy Scale (CSES)

    Change from baseline on CSES (1 month)

  • Coping Self-Efficacy Scale (CSES)

    Change from baseline on CSES (6 months)

Study Arms (2)

Coping Self-Efficacy

EXPERIMENTAL

Experimental condition enhancing coping self-efficacy

Behavioral: Personal resources' enhancement: self-efficacy

Waitlist control

NO INTERVENTION

Waitlist control condition

Interventions

Personal resources' enhancement: self-efficacyBEHAVIORAL

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.

Coping Self-Efficacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SWPS University of Social Sciences and Humanities

Warsaw, 00-864, Poland

Location

Related Publications (4)

  • 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.

    PMID: 30125790BACKGROUND

  • 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.

    PMID: 2648906BACKGROUND

  • 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.

    PMID: 35242591BACKGROUND

  • 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.

    PMID: 33427674BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ewelina Smoktunowicz, PhD

    1Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

October 10, 2022

Primary Completion

November 13, 2022

Study Completion

November 13, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)