Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults

Depression Clinical Trial

Official title:

Effectiveness of a Therapy Chatbot on Anxiety and Depressive Symptoms in Subclinical Young Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762939
• Other study ID #: RID_FIDO_RCT_1
• Status: Completed
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: August 2, 2022

Study information

• Verified date: February 2023
• Source: University of Social Sciences and Humanities, Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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 Poznan (Poland) to complete all measurements

Exclusion Criteria:

• undergoing psychotherapy, coaching or psychopharmacological treatment

• being diagnosed with a neurological disorder

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Laboratory of Affective Neuroscience in Poznan, SWPS University of Social Sciences and Humanities	Poznan	Greater Poland

Sponsors (2)

Lead Sponsor	Collaborator
University of Social Sciences and Humanities, Warsaw	Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).

External Links

•   OSF Preregistration