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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00AA029459-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized intervention condition | Experimental | This experimental condition will test a data-driven, person-specific intervention using CBT skills. |
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| Therapeutic control condition | Active Comparator | This control condition will provide an experimental comparison to test the process of personalization. |
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| Tracking control condition | Active Comparator | This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized intervention condition: Cognitive behavioral therapy skills | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions attended | The number of sessions completed (up to 11) will be used to measure treatment engagement. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn Piccirillo, PhD | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Robert Wood Johnson Medical School | Piscataway | New Jersey | 08901 | United States |
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| Therapeutic control condition: Cognitive behavioral therapy skills | Behavioral | 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. |
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| Tracking control condition: Supportive counseling | Behavioral | 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. |
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The Working Alliance Inventory self-report measure (or similar) will be used to measure changes in working 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 | Patient-rated improvements in functioning assessed will be assessed at (approximately) weekly intervals. | 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 | Clinician-rated improvements in functioning assessed will be assessed at the beginning and end of study participation, as well as at (approximately) weekly intervals. | 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) |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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