NCT05762939

Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults

Effectiveness of a Therapy Chatbot on Anxiety and Depressive Symptoms in Subclinical Young Adults: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Social Sciences and Humanities, Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This clinical trial compares the effects of using an artificial intelligence based therapy chatbot and a self-help book to lower anxiety and depressive symptoms. The therapy chatbot (named Fido) is an application delivering support for mental health via a conversation-like interface in a highly inflected language (Polish). The team will recruit young people (aged 18-35) who currently struggle with anxiety and/or depression. The participants will use the chatbot or self-help materials for two weeks. Then, the researchers will check if using the chatbot or the book improved several aspects of mental health and the quality of life. Moreover, they will compare the groups for any differences in outcomes.

Detailed description

The primary objective of this randomized controlled trial is to evaluate the effectiveness of a chatbot-delivered cognitive-behavioural intervention on anxiety and depressive symptoms (and their correlates, such as quality of life or feelings of loneliness) in a subclinical sample of about 80 participants. The intervention results are compared to an active control intervention with popular self-help materials. Secondary objectives include the assessment and analysis of the human-chatbot therapeutic bond and general user experience. The study uses a 2 x 3 mixed factorial design with two intervention arms (Fido chatbot vs self-help book) and three time points (T1: just prior to the intervention, T2: immediately after the intervention, T3: at a follow-up one month after the previous measurement). The primary intervention lasts two weeks. All primary and secondary outcomes are assessed using self-administered online questionnaires in Polish. Each primary outcome measure is analyzed using a 2 (arms) x 2 (time points) ANOVA models with T1-T2 comparisons to test for the intervention effect and T1-T3 comparisons to check the stability of the intervention effect. Additional analyzes utilize standard NHST calculations and procedures (such as t-tests and correlation coefficients) alongside the conventional ⍺=.05 level. Similarly to the previous research in this area, no blinding is used. Participants are informed about different conditions, but the research hypotheses are masked.

Conditions

• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Chatbot	Participants in this condition were asked to use Fido, a Polish therapy chatbot, for two weeks. No minimal requirements of usage time were enforced, but participants had to fill in five engagement check surveys during the intervention period. Each survey had to be completed in less than 24 hours.
BEHAVIORAL	Control (book)	Participants in this condition were told to read selected chapters from a self-help book during the two-week intervention period. No minimal requirements of usage time were enforced, but participants had to fill in five engagement check surveys during the intervention period. Each survey had to be completed in less than 24 hours.

Timeline

• Start date: 2022-05-03
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2023-03-10
• Last updated: 2023-03-10

Locations

1 site across 1 country: Poland