Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults

Not Applicable

Completed

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Control (book); Behavioral: Chatbot

• Registration Number: NCT05762939
• Lead Sponsor: University of Social Sciences and Humanities, Warsaw

Brief 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.

Study Timeline

• Study Start: 2022-05-03
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-02
• Status Verified: 2023-02
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• declaring at least mild depressive or anxiety symptoms by achieving a total score of at least 16 points on Center for Epidemiologic Studies Depression Scale Revised or at least 50 points on Penn State Worry Questionnaire
• being able to visit the study site in Poznań (Poland) to complete all measurements

Exclusion Criteria

• undergoing psychotherapy, coaching or psychopharmacological treatment
• being diagnosed with a neurological disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (book)	Control (book)	Intervention using self-help materials - chapters from a popular book on cognitive therapy, including worksheets.
Chatbot	Chatbot	Intervention using a pre-release version of Fido (https://fido.aid.pl), Polish AI-based therapy chatbot.

Primary Outcome Measures

Name	Time	Method
PHQ-9 Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum score of the Polish version of the Patient Health Questionnaire-9.
PSWQ Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum score of the Polish version of the Penn State Worry Questionnaire.
R-UCLA Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum score of the Polish version of the Revised UCLA Loneliness Scale.
CESD-R Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum score of the Polish version of the Center for Epidemiologic Studies Depression Scale Revised.
STAI Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum score of the Polish version of the State-Trait Anxiety Inventory.
SWLS Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum score of the Polish version of the Satisfaction With Life Scale.
PANAS Score Change	Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).	The total sum scores of the Polish version of the Positive and Negative Affect Scale in two subscales (Positive and Negative Affect, separately).

Trial Locations

Locations (1)

Laboratory of Affective Neuroscience in Poznań, SWPS University of Social Sciences and Humanities; 🇵🇱 Poznań, Greater Poland, Poland