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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Chatbot-based Internet Intervention for Stress Among University Students: A Randomized Controlled Trial

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: Personal resources' enhancement: self-efficacy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coping Self-Efficacy<br>Experimental condition enhancing coping self-efficacy | Behavioral: Personal resources' enhancement: self-efficacy<br>* 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.<br>|
| No Intervention: Waitlist control<br>Waitlist control condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Change from baseline on CSES (6 months) |