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Enrolling by invitation NCT05821634

Personalizing Treatment Delivery

No phase Interventional Anxiety Disorders and Symptoms PTSD and Trauma-related Symptoms Alcohol; Use, Problem; Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized intervention condition: Cognitive behavioral therapy skills, Therapeutic control condition: Cognitive behavioral therapy skills, Tracking control condition: Supportive counseling.
Who it may be relevant to
Registry conditions: Anxiety Disorders and Symptoms, PTSD and Trauma-related Symptoms, Alcohol; Use, Problem; Alcohol Use Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment

Overview

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.

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.

Primary outcome measures

  • Change in alcohol related risk [Time frame: Week 3, Week 15 (approximate)]
  • Change in risk drinking levels [Time frame: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Change in anxiety or anxiety-related symptom severity [Time frame: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Change in psychiatric diagnoses [Time frame: Week 3, Week 15 (approximate)]
Secondary outcome measures (4)
  • Number of sessions attended [Time frame: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Change in therapeutic alliance [Time frame: Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Patient-rated assessment of progress [Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Clinician-rated improvement in functioning [Time frame: Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]

Eligibility criteria

Inclusion criteria

  • Access to a smart phone
  • Between 18 and 65 years
  • Clinically significant anxiety or trauma-related symptoms
  • Alcohol use problems
  • Interest in telehealth counseling
  • Anticipated New Jersey or New York residence for the duration of the study

Exclusion criteria

  • Currently receiving individual counseling or counseling at a higher level of care
  • Psychiatric medication that is not currently at a stable dose (or is not anticipated to remain at a stable dose for the duration of the study)
  • Demonstrated indicators of more intensive or acute care
  • Temporary residence within the state of New Jersey or New York or out-of-state residence from the state of New Jersey or New York

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
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rutgers Robert Wood Johnson Medical School — Piscataway

Identifiers

NCT: NCT05821634 · STUDY00013899 · 4R00AA029459-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗