Stress, PsychologicalNCT05500209
Chatbot-based Internet Intervention for Stress Among University Students (Stressbot)
A study testing Personal resources' enhancement: self-efficacy in people with Stress, Psychological, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Personal resources' enhancement: self-efficacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 sitePoland
- Study dates
- 10 Oct 2022to 13 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of at least 18 years
- University students
- Mobile personal device with internet access
Who cannot join
- Not meeting at least 1 inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Personal resources' enhancement: self-efficacy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal resources' enhancement: self-efficacyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coping Self-Efficacy | Experimental | Experimental condition enhancing coping self-efficacy Receives: Behavioral: Personal resources' enhancement: self-efficacy |
| Waitlist control | No intervention | Waitlist control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline on BBQ (6 months)
Secondary outcomes (3)
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.
Measured: Change from baseline on CSES (7 days)
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.
Measured: Change from baseline on CSES (1 month)
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.
Measured: Change from baseline on CSES (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start10 Oct 2022
- Primary completion13 Nov 2022
- Study completion13 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewelina Smoktunowicz, University of Social Sciences and Humanities, Warsaw
- Investigators
- Ewelina Smoktunowicz, PhD, Principal investigator, 1Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500209
- Sponsor's protocol ID
- Stressbot
- Status last verified
- Jan 2023
- First submitted
- 11 Aug 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30125790Hobfoll 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.
PubMed 2648906Amanvermez 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.
PubMed 35242591Smoktunowicz 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.
PubMed 33427674
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chatbot-based Internet Intervention for Stress Among University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05500209
- Acronym / sponsor ID
- Stressbot
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 13 Nov 2022 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Self-Efficacy | Experimental | Behavioral: Personal resources' enhancement: self-efficacyExperimental condition enhancing coping self-efficacy |
| Waitlist control | No intervention | –Waitlist control condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of at least 18 years
- University students
- Mobile personal device with internet access
Key exclusion criteria (1 listed)
- Not meeting at least 1 inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal resources' enhancement: self-efficacyParticipants 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. | Behavioural | Coping Self-Efficacy |
Primary outcome
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 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 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 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 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 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.
3 secondary outcomes
Coping Self-Efficacy Scale (CSES)
Time frame: Change from baseline on CSES (7 days)
Coping Self-Efficacy Scale (CSES)
Time frame: Change from baseline on CSES (1 month)
Coping Self-Efficacy Scale (CSES)
Time frame: Change from baseline on CSES (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 30125790Bakker 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.
- Background: PubMed 2648906Hobfoll 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.
- Background: PubMed 35242591Amanvermez 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.
- Background: PubMed 33427674Smoktunowicz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewelina Smoktunowicz, PhD principal investigator
1Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal resources' enhancement: self-efficacy in people with Stress, Psychological, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Perceived Stress Scale 4 (PSS-4) (time frame: Change from baseline on PSS-4 (7 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500209, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023; AzTrials last refreshed its copy on 4 Nov 2026.