Personalizing Treatment Delivery

NCT05821634 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-05-19

No results posted yet for this study

Summary

Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.

Conditions

  • Anxiety Disorders and Symptoms
  • PTSD and Trauma-related Symptoms
  • Alcohol; Use, Problem; Alcohol Use Disorder

Interventions

BEHAVIORAL

Personalized intervention condition: Cognitive behavioral therapy skills

An 11-session cognitive behavioral therapy (CBT) skills based intervention will be delivered to participants randomized to the personalized intervention. Influential constructs will be identified using the person specific digital phenotyping model, targeted using CBT skills, and tracked across sessions.

BEHAVIORAL

Therapeutic control condition: Cognitive behavioral therapy skills

Participants randomized to this condition will receive an 11-session CBT skills based treatment targeting a non-personalized construct selected from the person-specific digital phenotyping model.

BEHAVIORAL

Tracking control condition: Supportive counseling

Participants randomized to this condition will receive 11 supportive counseling sessions that are non-directive in nature (providing support and validation for non-acute weekly stressors). Participants will continue digital phenotyping, controlling for the effect of counseling and digital phenotyping.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Marilyn Piccirillo, PhD · Rutgers Robert Wood Johnson Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2027-06-01
Completion
2027-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05821634 on ClinicalTrials.gov