Personalizing Treatment Delivery
Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment
2 other identifiers
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedMay 29, 2025
May 1, 2025
1.5 years
March 26, 2023
May 22, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Change in alcohol related risk
The Alcohol Use Disorder Identification Test (AUDIT) self-report measure (or similar) will be used to assess changes in alcohol related risk.
Week 3, Week 15 (approximate)
Change in risk drinking levels
The Daily Drinking Questionnaire (DDQ) self-report measure (or similar) will be used to measure changes in alcohol consumption/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)
Change in anxiety or anxiety-related symptom severity
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.
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
A diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of participation.
Week 3, Week 15 (approximate)
Secondary Outcomes (4)
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)
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)
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)
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)
Study Arms (3)
Personalized intervention condition
EXPERIMENTALThis experimental condition will test a data-driven, person-specific intervention using CBT skills.
Therapeutic control condition
ACTIVE COMPARATORThis control condition will provide an experimental comparison to test the process of personalization.
Tracking control condition
ACTIVE COMPARATORThis second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers Robert Wood Johnson Medical School
Piscataway, New Jersey, 08901, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marilyn Piccirillo, PhD
Rutgers Robert Wood Johnson Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 26, 2023
First Posted
April 20, 2023
Study Start
October 21, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
May 29, 2025
Record last verified: 2025-05