Clinical trial NCT05762939: Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults
Official title: Effectiveness of a Therapy Chatbot on Anxiety and Depressive Symptoms in Subclinical Young Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: anxiety
depression
quality of life
loneliness
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2023-03-10
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: CESD-R Score Change
timeFrame: 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).
measure: PHQ-9 Score Change
timeFrame: 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).
measure: PSWQ Score Change
timeFrame: 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).
measure: SWLS Score Change
timeFrame: 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).
measure: PANAS Score Change
timeFrame: 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).
measure: STAI Score Change
timeFrame: 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).
measure: R-UCLA Score Change
timeFrame: 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).
Secondary outcomes:
Other outcomes:
measure: ACC Score
timeFrame: Time point 2: Immediately after two weeks of the intervention.
measure: HCI Scores
timeFrame: Time point 2: Immediately after two weeks of the intervention.
measure: LP Score
timeFrame: Time point 2: Immediately after two weeks of the intervention.
measure: WAI-SR Score
timeFrame: Time point 2: Immediately after two weeks of the intervention.
measure: Psychoeducation Test Score
timeFrame: Time point 2: Immediately after two weeks of the intervention.
Locations:
city: Poznań
country: Poland
facility: Laboratory of Affective Neuroscience in Poznań, SWPS University of Social Sciences and Humanities
state: Greater Poland
Study officials:
affiliation: SWPS University of Social Sciences and Humanities, Warsaw, Poland
name: Jarosław Michałowski, PhD
role: PRINCIPAL_INVESTIGATOR
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