Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults

NCT05762939 | Completed

• 1 other identifier: RID_FIDO_RCT_1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

anxiety; depression; quality of life; loneliness

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• ACC Score

  Time point 2: Immediately after two weeks of the intervention.

• HCI Scores

  Time point 2: Immediately after two weeks of the intervention.

• LP Score

  Time point 2: Immediately after two weeks of the intervention.

Study Arms (2)

Chatbot

EXPERIMENTAL

Intervention using a pre-release version of Fido (https://fido.aid.pl), Polish AI-based therapy chatbot.

Behavioral: Chatbot

Control (book)

ACTIVE COMPARATOR

Intervention using self-help materials - chapters from a popular book on cognitive therapy, including worksheets.

Behavioral: Control (book)

Interventions

Chatbot BEHAVIORAL

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.

Chatbot

Control (book) BEHAVIORAL

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.

Control (book)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Laboratory of Affective Neuroscience in Poznań, SWPS University of Social Sciences and Humanities

Poznan, Greater Poland Voivodeship, 61-719, Poland

Location

Related Publications (12)

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• 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.

  PMID: 7431205 BACKGROUND

• 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.

  PMID: 20013760 BACKGROUND

• 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.

  PMID: 34898233 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 28211550 BACKGROUND

• 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.

  PMID: 28588005 BACKGROUND

• 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.

  PMID: 15333231 BACKGROUND

• 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.

  PMID: 2076086 BACKGROUND

• 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.

  PMID: 33386535 BACKGROUND

• 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.

  PMID: 22588767 BACKGROUND

• Karkosz S, Szymanski R, Sanna K, Michalowski J. Effectiveness of a Web-based and Mobile Therapy Chatbot on Anxiety and Depressive Symptoms in Subclinical Young Adults: Randomized Controlled Trial. JMIR Form Res. 2024 Mar 20;8:e47960. doi: 10.2196/47960.

  PMID: 38506892 DERIVED

Related Links

• OSF Preregistration

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jarosław Michałowski, PhD

  SWPS University of Social Sciences and Humanities, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 10, 2023
• Study Start: May 3, 2022
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: March 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, 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.

Locations

PL (1)