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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Chatbot; Behavioral: Control (book)

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Greater Poland
    • Poznań, Greater Poland, Poland, 61-719
      • Laboratory of Affective Neuroscience in Poznań, SWPS University of Social Sciences and Humanities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CESD-R Score Change	The total sum score of the Polish version of the Center for Epidemiologic Studies Depression Scale Revised.	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 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 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 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 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 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 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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACC Score	The total sum score of the Polish version of the Acceptability E-scale. Used exclusively in the chatbot arm.	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 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 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 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 point 2: Immediately after two weeks of the intervention.

Collaborators and Investigators

• Sponsor: University of Social Sciences and Humanities, Warsaw
• Collaborators: Ministry of Science and Higher Education, Poland
• Investigators: Principal Investigator: Jarosław Michałowski, PhD, SWPS University of Social Sciences and Humanities, Warsaw, Poland

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
• Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
• Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
• Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.
• Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.
• Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
• Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.
• Moshe I, Terhorst Y, Philippi P, Domhardt M, Cuijpers P, Cristea I, Pulkki-Raback L, Baumeister H, Sander LB. Digital interventions for the treatment of depression: A meta-analytic review. Psychol Bull. 2021 Aug;147(8):749-786. doi: 10.1037/bul0000334.
• Koziara K. Assessment of depressiveness in population. Psychometric evaluation of the Polish version of the CESD-R. Psychiatr Pol. 2016 Dec 23;50(6):1109-1117. doi: 10.12740/PP/61614. English, Polish.
• Kusier AO, Folker AP. The Satisfaction with Life Scale: Philosophical Foundation and Practical Limitations. Health Care Anal. 2021 Mar;29(1):21-38. doi: 10.1007/s10728-020-00420-y. Epub 2021 Jan 2.

Helpful Links

• OSF Preregistration

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): August 2, 2022

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; depression; anxiety; loneliness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: RID_FIDO_RCT_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data from all enrolled participants will be publicly available in the project's OSF repository.
• IPD Sharing Time Frame: IPD and supporting documents will be available as soon as research results are published.
• IPD Sharing Access Criteria: IPD and supporting documents will be publicly available.
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No