Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety (NCT07430800) | Clinical Trial Compass
RecruitingNot Applicable
Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety
United States140 participantsStarted 2026-03-30
Plain-language summary
Untreated anxiety undermines long-term physical and emotional wellbeing, especially among college students, with rates worsening since the onset of the COVID-19 pandemic. Cognitive Behavioral Therapy (CBT) is the leading evidence-based intervention for anxiety, but many students fail to complete exercises between CBT sessions, reducing its effectiveness. Socially assistive robots (SARs) help promote adherence to home-based practice in the context of elder care, social skill learning, and physical therapy, but it is unknown how SARs can enhance CBT. The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety. To meet the goals of the proposed work, these studies will determine how SAR personalization based on implicit and explicit feedback can help promote greater CBT compliance and anxiety reduction outcomes for students.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are 18 years of age or older
* Are university students
* Are able to communicate in English
* Have corrected-to-normal vision and hearing
* Consent to have audio/video/interaction data recorded as part of the study
* Have a GAD-7 (Generalized Anxiety Disorder-7 item) score of 5 or greater, indicating mild to elevated levels of self-reported symptoms of anxiety
* Have a lower than minimal level of suicidality risk as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) during screening ("NO" responses to items 3, 4, 5, and 6 on C-SSRS)
* Having access to home WiFi
Exclusion Criteria:
* Are less than 18 years of age
* Are not university students
* Are not able to communicate in English
* Do not have corrected-to-normal vision and hearing
* Do not consent to have audio/video/interaction data recorded as part of the study
* Have a GAD-7 (Generalized Anxiety Disorder-7 item) score of 4 or lower.
* Higher than a minimal level of suicidality risk as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) during screening ("YES" responses to items 3, 4, 5, or 6 on C-SSRS)
* Don't have access to home WiFi
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of user-spoken words during interactions with SAR
Timeframe: During each session, through study completion, approximately 6 weeks.
2
Overall length of interaction sessions
Timeframe: Through the duration of the study, approximately 6 weeks.
3
Number of days participants complete CBT exercises (adherence)
Timeframe: Through study completion, approximately 6 weeks.
4
Outcomes Questionnaire-45.2
Timeframe: Once in weeks 1, 3, 6 of the study.
5
Modified Working Alliance Inventory-Short Revised
Timeframe: Once in weeks 2, 4, 6 of study.
6
Sustem Usability Scale
Timeframe: Once on Week 2 Day 4 and Week 6 Day 4.
7
Semi-structured interview
Timeframe: One interview for 30 minutes - 120 minutes at the end of the 6 week study.