Clinical trial NCT05821634: Personalizing Treatment Delivery
Official title: Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders and Symptoms
PTSD and Trauma-related Symptoms
Alcohol; Use, Problem; Alcohol Use Disorder
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-04-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Change in alcohol related risk
timeFrame: Week 3, Week 15 (approximate)
measure: Change in risk drinking levels
timeFrame: 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)
measure: Change in anxiety or anxiety-related symptom severity
timeFrame: 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)
measure: Change in psychiatric diagnoses
timeFrame: Week 3, Week 15 (approximate)
Secondary outcomes:
measure: Number of sessions attended
timeFrame: 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)
measure: Change in therapeutic alliance
timeFrame: 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)
measure: Patient-rated assessment of progress
timeFrame: 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)
measure: Clinician-rated improvement in functioning
timeFrame: 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)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Marilyn Piccirillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: