Personalized CBT for Anxiety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Under 18, Not university student, others

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Consent to have audio/video/interaction data recorded as part of the study

Are university students

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

Exclusion Criteria

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)

Do not consent to have audio/video/interaction data recorded as part of the study

Don't have access to home WiFi

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Initial in-home visit where participants receive SAR and instructions for CBT exercises

1 day

1 visit (in-person)

Treatment

Participants engage in 6 weeks of in-home CBT daily exercises with SAR

6 weeks

Daily interactions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBT SAR Personalization

How Is the Trial Designed?

Group I: Implicit CBT SAR Personalization for 6 weeks Experimental Treatment 1 Intervention

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.

Group II: Explicit CBT SAR Personalization for 6 weeks Experimental Treatment 1 Intervention

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.

Group III: Control CBT SAR for 6 weeks Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+