NCT07430800 · University of Southern California
Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Number of user-spoken words during interactions with SAR
Time frame: During each session, through study completion, approximately 6 weeks.
Using transcriptions of the interactions, the investigators will count the number of words uttered by the participant.
Overall length of interaction sessions
Time frame: Through the duration of the study, approximately 6 weeks.
Using the interaction data from the robot interface, the investigators will collect the time that the participant started the interaction with the robot and the time that the interaction ended.
Number of days participants complete CBT exercises (adherence)
Time frame: Through study completion, approximately 6 weeks.
Using the interaction data from the robot interface, the investigators will collect the number of days that the participant interacts with the system at least once during the day
Outcomes Questionnaire-45.2
Time frame: Once in weeks 1, 3, 6 of the study.
The total reported symptom distress value from the symptom distress subscale. Question scale (0-4). A higher total score indicates higher distress overall, and higher scores for question subsets indicate worse outcomes for symptom distress, interpersonal relations, and social role.
Modified Working Alliance Inventory-Short Revised
Time frame: Once in weeks 2, 4, 6 of study.
Repeated daily measure for assessing the quality of the relationship with the SAR companion. Question scale (1-5). Higher scores indicate stronger alliance.
Sustem Usability Scale
Time frame: Once on Week 2 Day 4 and Week 6 Day 4.
The total reported usability score for evaluating participant perception of SAR companion's usability. Question responses scale from strongly agree to strongly disagree. Responses should not indicate trends in participant outcomes, but should instead help the investigators understand participants' perception of the system.
Semi-structured interview
Time frame: One interview for 30 minutes - 120 minutes at the end of the 6 week study.
Focus group interviews with the investigators and participants will be used to process for collecting qualitative feedback and insights. The investigators will use this data to perform thematic analysis of participant responses while using the system.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations