Personalizing Treatment Delivery

Not Applicable

Recruiting

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

• Registration Number: NCT05821634
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-20
• Study Start: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-05
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

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 counseling
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in alcohol related risk	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.
Change in risk drinking levels	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.
Change in anxiety or anxiety-related symptom severity	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.
Change in psychiatric diagnoses	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 Outcome Measures

Name	Time	Method
Number of sessions attended	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.
Change in therapeutic alliance	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.
Patient-rated assessment of progress	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.
Clinician-rated improvement in functioning	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.

Trial Locations

Locations (1)

Rutgers Robert Wood Johnson Medical School; 🇺🇸 Piscataway, New Jersey, United States