Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change in psychiatric diagnoses
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tracking control condition
This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.
干预措施: Tracking control condition: Supportive counseling (Behavioral)
Personalized intervention condition
This experimental condition will test a data-driven, person-specific intervention using CBT skills.
干预措施: Personalized intervention condition: Cognitive behavioral therapy skills (Behavioral)
Therapeutic control condition
This control condition will provide an experimental comparison to test the process of personalization.
干预措施: Therapeutic control condition: Cognitive behavioral therapy skills (Behavioral)
结局指标
主要结局
Change in psychiatric diagnoses
时间窗: Week 3, Week 15 (approximate)
A diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of participation.
Change in alcohol related risk
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Marilyn L. Piccirillo, Ph.D.
Assistant Professor
Rutgers, The State University of New Jersey