Recruiting

CBT with SARsPersonalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety

Sponsor:

University of Southern California

Code:

NCT07430800

Conditions

Generalized Anxiety Disorder (GAD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Explicit CBT SAR Personalization for 6 weeks

Implicit CBT SAR Personalization for 6 weeks

Control CBT SAR for 6 weeks

Study Details

Brief 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.

Conditions

Generalized Anxiety Disorder (GAD)

Study ID

NCT07430800

Start date

Mar 30, 2026

Status verified date

Feb, 2026

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Feb 14, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Explicit CBT SAR Personalization for 6 weeks

College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with an explicitly personalized CBT SAR in the participants' homes. Each participant will receive personalized re-engagement feedback delivered by the SAR will be based on explicit user feedback regarding the participant's subjective preferences related to the robot attributes and engagement features.

experimental: Implicit CBT SAR Personalization for 6 weeks

College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBI daily exercises with an implicitly personalized CBT SAR in the participants' homes. The personalized re-engagement feedback provided by the SAR will be based on machine learning methods applied to implicit visual and auditory cues.

placebo comparator: Control CBT SAR for 6 weeks

College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with a non-personalized CBT SAR in the participants' homes. Participants will not have the capability to personalize the robot's attributes, and this condition will be a control baseline comparison group for the personalized intervention conditions described above.

Interventions

Explicit CBT SAR Personalization for 6 weeks

College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with an explicitly personalized CBT SAR in the participants' homes. Participants will receive personalized re-engagement feedback delivered by the SAR will be based on explicit user feedback regarding their subjective preferences related to the robot attributes and engagement features.

Implicit CBT SAR Personalization for 6 weeks

Control CBT SAR for 6 weeks

College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with a non-personalized CBT SAR. Participants will not have the capability to personalize the robot's attributes, and this condition will be a control baseline comparison group for the personalized intervention conditions described above.

Primary outcome measure

Number of user-spoken words during interactions with SAR [ Time Frame: During each session, through study completion, approximately 6 weeks. ]
Overall length of interaction sessions [ Time Frame: Through the duration of the study, approximately 6 weeks. ]
Number of days participants complete CBT exercises (adherence) [ Time Frame: Through study completion, approximately 6 weeks. ]
Outcomes Questionnaire-45.2 [ Time Frame: Once in weeks 1, 3, 6 of the study. ]
Modified Working Alliance Inventory-Short Revised [ Time Frame: Once in weeks 2, 4, 6 of study. ]
Sustem Usability Scale [ Time Frame: Once on Week 2 Day 4 and Week 6 Day 4. ]
Semi-structured interview [ Time Frame: One interview for 30 minutes - 120 minutes at the end of the 6 week study. ]

Central Contacts and Locations

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Lydia Ignatova

714-855-7076 lignatov@usc.edu

Emily Weiss

402-237-2492 emilymwe@usc.edu

Principal Investigator:

Maja Matarić, PhD

More Information

Sponsor

University of Southern California

Last update posted

Jun 8, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-08.