Alcohol; Use, Problem; Alcohol Use Disorder, Anxiety Disorders and Symptoms, PTSD and Trauma-related Symptoms
Conditions
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.
Interventions
BEHAVIORALPersonalized 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.
BEHAVIORALTherapeutic 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.
BEHAVIORALTracking 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.
Sponsors
Rutgers, The State University of New Jersey
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarilyn Piccirillo, PhD
Rutgers Robert Wood Johnson Medical School
Outcome results
None listed