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OpenTrials
Enrolling by Invitation

NCT Number: NCT05821634

Personalizing Treatment Delivery

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.

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Key information

Conditions

Anxiety Disorders and Symptoms Alcohol-Related Disorders Alcohol; Use, Problem; Alcohol Use Disorder Alcoholism Anxiety Disorders Chemically-Induced Disorders Mental Disorders PTSD and Trauma-related Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Robert Wood Johnson Medical School

Piscataway, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in alcohol related risk

    Time frame: Week 3, Week 15 (approximate)

    The Alcohol Use Disorder Identification Test (AUDIT) self-report measure (or similar) will be used to assess changes in alcohol related risk.

  2. 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)

    The Daily Drinking Questionnaire (DDQ) self-report measure (or similar) will be used to measure changes in alcohol consumption/risk drinking levels.

  3. 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)

    The Overall Anxiety Severity and Impairment Scale (OASIS) self-report measure (or similar) will be used to assess changes in anxiety and anxiety-related symptom severity.

  4. Change in psychiatric diagnoses

    Time frame: Week 3, Week 15 (approximate)

    A diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of participation.

Secondary outcomes

  1. 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)

    The number of sessions completed (up to 11) will be used to measure treatment engagement.

  2. 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)

    The Working Alliance Inventory self-report measure (or similar) will be used to measure changes in working therapeutic alliance.

  3. 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)

    Patient-rated improvements in functioning assessed will be assessed at (approximately) weekly intervals.

  4. 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)

    Clinician-rated improvements in functioning assessed will be assessed at the beginning and end of study participation, as well as at (approximately) weekly intervals.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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