Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are 18 years of age or older

Are university students

Are able to communicate in English

Have corrected-to-normal vision and hearing

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Explicit CBT SAR Personalization for 6 weeks

    Behavioral

    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

    Behavioral

    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.

  • Control CBT SAR for 6 weeks

    Behavioral

    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.

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: Explicit CBT SAR Personalization for 6 weeksExperimental treatment 1 intervention
Group B: Implicit CBT SAR Personalization for 6 weeksExperimental treatment 1 intervention
Group C: Control CBT SAR for 6 weeksPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of user-spoken words during interactions with SAR

Using transcriptions of the interactions, the investigators will count the number of words uttered by the participant.

Time frame
During each session, through study completion, approximately 6 weeks.
2

Overall length of interaction sessions

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.

Time frame
Through the duration of the study, approximately 6 weeks.
3

Number of days participants complete CBT exercises (adherence)

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

Time frame
Through study completion, approximately 6 weeks.
4

Outcomes Questionnaire-45.2

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.

Time frame
Once in weeks 1, 3, 6 of the study.

Secondary outcomes

Other outcomes

1

GAD-7 Questionnaire

Screening measure for identifying students with elevated levels of anxiety. Question scale (0-3). A higher total score indicates higher levels of anxiety.

Time frame
Once in weeks 2, 4, 6 of the study.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator