An interventional study of Chatbot and Control (book) in Anxiety and Depression, sponsored by University of Social Sciences and Humanities, Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by University of Social Sciences and Humanities, Warsaw · Not applicable, Interventional, and Treatment
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.
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.
5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 81 is close to the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Social Sciences and Humanities, Warsaw is the lead sponsor of 25 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Intervention using a pre-release version of Fido (https://fido.aid.pl), Polish AI-based therapy chatbot.
Behavioral: Chatbot
Intervention using self-help materials - chapters from a popular book on cognitive therapy, including worksheets.
Behavioral: Control (book)
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.
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.
CESD-R Score Change
The total sum score of the Polish version of the Center for Epidemiologic Studies Depression Scale Revised.
Time frame: 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).
PHQ-9 Score Change
The total sum score of the Polish version of the Patient Health Questionnaire-9.
Time frame: 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).
PSWQ Score Change
The total sum score of the Polish version of the Penn State Worry Questionnaire.
Time frame: 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).
SWLS Score Change
The total sum score of the Polish version of the Satisfaction With Life Scale.
Time frame: 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).
PANAS Score Change
The total sum scores of the Polish version of the Positive and Negative Affect Scale in two subscales (Positive and Negative Affect, separately).
Time frame: 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).
STAI Score Change
The total sum score of the Polish version of the State-Trait Anxiety Inventory.
Time frame: 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).
R-UCLA Score Change
The total sum score of the Polish version of the Revised UCLA Loneliness Scale.
Time frame: 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).
ACC Score
The total sum score of the Polish version of the Acceptability E-scale. Used exclusively in the chatbot arm.
Time frame: Time point 2: Immediately after two weeks of the intervention.
HCI Scores
The total sum scores of six subscales from the Human-Computer Interaction Scale. Used exclusively in the chatbot arm.
Time frame: Time point 2: Immediately after two weeks of the intervention.
LP Score
Individual item scores from Language Pragmaticality Scale. Used exclusively in the chatbot arm.
Time frame: Time point 2: Immediately after two weeks of the intervention.
WAI-SR Score
The total sum score of the Polish version of the Working Alliance Inventory Short Revised. The Polish translation of this measure was developed by the research team. Used exclusively in the chatbot arm.
Time frame: Time point 2: Immediately after two weeks of the intervention.
Psychoeducation Test Score
The total sum score of the 12-item test which assessed the participants' acquired knowledge of psychoeducation topics.
Time frame: Time point 2: Immediately after two weeks of the intervention.
Plan to share: Yes — Anonymized data from all enrolled participants will be publicly available in the project's OSF repository.
Supporting information: Informed consent form, Analytic code
Time frame: IPD and supporting documents will be available as soon as research results are published.
Access criteria: IPD and supporting documents will be publicly available.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Social Sciences and Humanities, Warsaw