Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety

Official title

SCH: Personalized AI-Driven Models for Supporting User Engagement and Adherence in Health Interventions: Validation in Cognitive Behavioral Therapy for Anxiety

Overview

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.

Detailed description

The investigators will conduct a Phase 1 parallel intervention study with random assignment. The investigators will randomly assign consented college students reporting anxiety symptoms to one of two 6-week Cognitive Behavioral Therapy (CBT) exercise conditions that were validated in our preliminary studies. The participant will be randomly assigned to a condition (personalized versus not personalized socially assistive robot (SAR) CBT) and will be informed of their condition by the investigators when the participant is ready to start their home practice with the SAR CBT companion. During the initial baseline in-home visit, participants will be provided with a SAR and instructions for how to complete their SAR CBT exercises daily for 6 weeks. During the 6-week home-based study period that follows the baseline visit, the participant will be reminded daily to complete a CBT exercise with their SAR. The investigators will be the point of contact via phone or email for all participants who need assistance (e.g., with SAR/software issues).

The investigators will evaluate personalized re-engagement strategies derived from implicit feedback from individuals with clinically elevated anxiety. This will be done through an in-home between-subjects user study involving 60 student participants who will be randomly assigned to either a control condition without re-engagement feedback or a personalized feedback condition with personalized re-engagement feedback. Quantitative behavioral and subjective metrics will be compared between the conditions to assess the impact of personalized feedback on feelings of relatedness with the robot, intrinsic motivation, engagement, and adherence, guided by self-determination theory. The study aims to determine whether personalized re-engagement feedback enhances the intrinsic motivation, engagement, and adherence when using the SAR companion to deliver CBT concepts to individuals with clinically elevated anxiety.

The second aim is to evaluate the personalization of robot attributes based on explicit user feedback in individuals with clinically elevated anxiety. This will be done through an in-home between-subjects user study where 60 participants are randomly assigned to either a control condition without the capability to personalize the robot's attributes or a personalization condition where the participant can modify the robot's attributes at the start of the study and between CBT sessions. This study aims to determine whether granting users the ability to choose the robot's attributes will lead to higher levels of intrinsic motivation, engagement, and adherence during interaction with the SAR companion.

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.]
• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Southern California — Los Angeles

Identifiers

NCT: NCT07430800 · R01MH139134-At-Home · R01MH139134

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗