AnxietyNCT05762939
Chatbot Intervention for Anxiety and Depressive Symptoms in Young Adults
A study testing Chatbot in people with Anxiety and Depression, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 sitePoland
- Study dates
- 3 May 2022to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- undergoing psychotherapy, coaching or psychopharmacological treatment
- being diagnosed with a neurological disorder
Trial locations and contacts
1 site in 1 country.
Poland1 site
Laboratory of Affective Neuroscience in Poznań, SWPS University of Social Sciences and Humanities
Poznan, Greater Poland Voivodeship, 61-719
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Chatbot, Control (book)
- Keywords
- anxiety, depression, quality of life, loneliness
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot | Experimental | Intervention using a pre-release version of Fido (https://fido.aid.pl), Polish AI-based therapy chatbot. Receives: Behavioral: Chatbot |
| Control (book) | Active comparator | Intervention using self-help materials - chapters from a popular book on cognitive therapy, including worksheets. Receives: Behavioral: Control (book) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CESD-R Score Change
The total sum score of the Polish version of the Center for Epidemiologic Studies Depression Scale Revised.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start3 May 2022
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Responsible party
- Sponsor
- Investigators
- Jarosław Michałowski, PhD, Principal investigator, SWPS University of Social Sciences and Humanities, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762939
- Sponsor's protocol ID
- RID_FIDO_RCT_1
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data from all enrolled participants will be publicly available in the project's OSF repository.
Publications
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.
PubMed 20974066Russell 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.
PubMed 7431205Munder 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.
PubMed 20013760Moshe 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.
PubMed 34898233Kroenke 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.
PubMed 11556941Koziara 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.
PubMed 28211550Fitzpatrick 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.
PubMed 28588005Crawford 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.
PubMed 15333231Meyer 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.
PubMed 2076086Kusier 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.
PubMed 33386535Julian 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.
PubMed 22588767Karkosz 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.
PubMed 38506892
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Therapy Chatbot on Anxiety and Depressive Symptoms in Subclinical Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05762939
- Acronym / sponsor ID
- RID_FIDO_RCT_1
- Conditions
- Anxiety, Depression
- Keywords
- anxiety, depression, quality of life, loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Study start
- 3 May 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot | Experimental | Behavioral: ChatbotIntervention using a pre-release version of Fido (https://fido.aid.pl), Polish AI-based therapy chatbot. |
| Control (book) | Active comparator | Behavioral: Control (book)Intervention using self-help materials - chapters from a popular book on cognitive therapy, including worksheets. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- undergoing psychotherapy, coaching or psychopharmacological treatment
- being diagnosed with a neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatbotParticipants 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. | Behavioural | Chatbot |
| 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. | Behavioural | Control (book) |
Primary outcome
CESD-R Score Change
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).
The total sum score of the Polish version of the Center for Epidemiologic Studies Depression Scale Revised.
PHQ-9 Score Change
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).
The total sum score of the Polish version of the Patient Health Questionnaire-9.
PSWQ Score Change
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).
The total sum score of the Polish version of the Penn State Worry Questionnaire.
SWLS Score Change
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).
The total sum score of the Polish version of the Satisfaction With Life Scale.
PANAS Score Change
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).
The total sum scores of the Polish version of the Positive and Negative Affect Scale in two subscales (Positive and Negative Affect, separately).
STAI Score Change
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).
The total sum score of the Polish version of the State-Trait Anxiety Inventory.
R-UCLA Score Change
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).
The total sum score of the Polish version of the Revised UCLA Loneliness Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 20974066Tariman 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.
- Background: PubMed 7431205Russell 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.
- Background: PubMed 20013760Munder 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.
- Background: PubMed 34898233Moshe 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 28211550Koziara 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.
- Background: PubMed 28588005Fitzpatrick 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.
- Background: PubMed 15333231Crawford 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.
- Background: PubMed 2076086Meyer 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.
- Background: PubMed 33386535Kusier 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.
- Background: PubMed 22588767Julian 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.
- Derived from this study: PubMed 38506892Karkosz 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.
- OSF PreregistrationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data from all enrolled participants will be publicly available in the project's OSF repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarosław Michałowski, PhD principal investigator
SWPS University of Social Sciences and Humanities, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Anxiety and Depression, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CESD-R Score Change (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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762939, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.