140 Participants NeededMy employer runs this trial

Personalized CBT for Anxiety

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how socially assistive robots (SARs) can help college students adhere to their Cognitive Behavioral Therapy (CBT) exercises for anxiety management. It tests whether personalizing these robots, through direct user feedback or cues like facial expressions and voice tones, can enhance therapy outcomes. The goal is to determine if personalized robots can make CBT more effective for students with anxiety. This trial suits college students who frequently experience anxiety and are open to using technology at home to manage their symptoms. As an unphased trial, it offers students the chance to engage with innovative technology that could enhance their therapy experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using personalized CBT with socially assistive robots for anxiety.

What prior data suggests that this CBT SAR personalization is safe for college students with anxiety?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and effective for treating anxiety disorders in various settings. Studies on both online and in-person CBT programs indicate that most patients receive them well. Although specific studies on the safety of using socially assistive robots (SARs) for personalized CBT are lacking, previous research on digital and internet-based CBT methods suggests they are safe and usually don't cause serious negative effects.

In digital CBT trials, participants have reported few negative experiences. In some cases, about 0-10% of patients felt their anxiety worsened, and 10-19% left the studies early. These numbers suggest that while CBT might not help everyone, most people do not experience significant harm.

Personalized CBT with SARs is a new area of research, but given CBT's safety record in other formats, it is likely to be safe. This trial examines how SARs can help college students maintain their CBT exercises, potentially improving their anxiety management.12345

Why are researchers excited about this trial?

Researchers are excited about these personalized CBT (Cognitive Behavioral Therapy) treatments for anxiety because they offer a unique approach compared to standard therapy methods. Unlike traditional CBT, which is generally one-size-fits-all, these treatments use Socially Assistive Robots (SARs) to deliver therapy that is tailored to each person. In one method, the therapy is explicitly personalized based on user feedback about the robot's features, while another method uses machine learning to adapt based on visual and auditory cues. This personalization could make therapy more engaging and effective, potentially leading to better outcomes for individuals struggling with anxiety.

What evidence suggests that CBT SAR personalization is effective for anxiety?

Studies have shown that Cognitive Behavioral Therapy (CBT) effectively reduces anxiety. Research suggests that customizing CBT to fit individual needs can enhance its effectiveness. In this trial, participants will join different treatment arms to evaluate these approaches. Reviews have shown that the Explicit CBT SAR Personalization treatment arm helps people adhere to therapy and reduce anxiety more effectively. Similarly, the Implicit CBT SAR Personalization treatment arm uses machine learning to adapt to user behavior, which has been linked to improved participation and anxiety relief. Overall, using technology like socially assistive robots (SARs) to personalize CBT aims to keep users more engaged, potentially leading to better anxiety management.46789

Are You a Good Fit for This Trial?

This trial is for university students aged 18 or older who speak English, have mild to high anxiety (GAD-7 score of 5+), can use home WiFi, have normal vision and hearing (with correction if needed), and are at minimal risk for suicide. Participants must agree to audio/video recording during the study.

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
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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
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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

Trial Overview

The study compares three types of socially assistive robots (SARs) that help deliver cognitive behavioral therapy (CBT) for anxiety over six weeks: one with explicit personalization, one with implicit personalization, and a standard version without extra personalization.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Implicit CBT SAR Personalization for 6 weeksExperimental Treatment1 Intervention
Group II: Explicit CBT SAR Personalization for 6 weeksExperimental Treatment1 Intervention
Group III: Control CBT SAR for 6 weeksPlacebo Group1 Intervention

Find a Clinic Near You

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+

Citations

Study protocol for a randomized controlled trial

Discussion Anticipated outcomes from this study include advancements in personalized CBT for anxiety disorders, contributing valuable ...

Efficacy of an Unguided, Digital Single-Session ...

The main outcomes were short-term (2 weeks) and long-term (8 weeks) changes in depression and anxiety. The secondary outcomes were the 8-week ...

Personalized AI-Driven Models in Cognitive Behavioral ...

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 ...

Efficacy of a process-based, Mobile-delivered personalized ...

A systematic review indicated that the overall treatment response rate for ICBT across various psychological conditions is approximately 69.9 %, ...

Personalized CBT for Anxiety

The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety.

Safety and Efficacy of Modular Digital Psychotherapy ... - PMC

The web-only, modular social anxiety CBT program appeared safe, acceptable, and efficacious in 2 independent RCTs on online patient groups with self-reported ...

Comparison of Disorder-Specific Group CBT and Generic ...

Cognitive behavioral therapy (CBT) is the best-documented treatment for anxiety disorders in children and adolescents (James et al., 2020).

Anxiety & Depression Association of America

The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety.

A systematic review on personalization of treatment ...

This systematic review aimed to synthesize evidence on the personalization of treatment components within IBIs targeting diverse mental health conditions.