Personalizing Treatment Delivery

Part of paid clinical trials in Piscataway, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05821634
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized intervention condition: Cognitive behavioral therapy skills — BEHAVIORAL
    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.
  • Therapeutic control condition: Cognitive behavioral therapy skills — BEHAVIORAL
    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.
  • Tracking control condition: Supportive counseling — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized intervention condition
    This experimental condition will test a data-driven, person-specific intervention using CBT skills.
  • Active Comparator: Therapeutic control condition
    This control condition will provide an experimental comparison to test the process of personalization.
  • Active Comparator: Tracking control condition
    This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.

Primary Outcome Measure

Change in alcohol related risk [ Time Frame: Week 3, Week 15 (approximate) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Robert Wood Johnson Medical SchoolPiscatawayNew Jersey08901-

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Rutgers Robert Wood Johnson Medical School· Piscataway, NJ

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