Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
81 participants
INTERVENTIONAL
2024-10-21
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Personalized intervention condition
This experimental condition will test a data-driven, person-specific intervention using CBT skills.
Personalized intervention condition: Cognitive behavioral therapy skills
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
This control condition will provide an experimental comparison to test the process of personalization.
Therapeutic control condition: Cognitive behavioral therapy skills
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
This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.
Tracking control condition: Supportive counseling
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.
Interventions
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Personalized intervention condition: Cognitive behavioral therapy skills
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
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
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
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Marilyn L. Piccirillo, Ph.D.
Assistant Professor
Principal Investigators
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Marilyn Piccirillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Locations
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Rutgers Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Marilyn Piccirillo, PhD
Role: primary
Other Identifiers
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STUDY00013899
Identifier Type: -
Identifier Source: org_study_id
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