RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Clinician-Administered Rating Scale for Mania (CARS-M)
研究概览
简要总结
This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a bipolar-spectrum disorder
- •Diagnosis of a substance use disorder
- •Taking at least one mood-stabilizing medication
排除标准
- •Unable to speak and read English
- •Younger than age 18
研究组 & 干预措施
Safety Assessment and Follow-up Evaluation (SAFE)
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
干预措施: Safety Assessment and Follow-up Evaluation (SAFE) (Behavioral)
Integrated Treatment Adherence Program (ITAP)
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
干预措施: Integrated Treatment Adherence Program (ITAP) (Behavioral)
结局指标
主要结局
Clinician-Administered Rating Scale for Mania (CARS-M)
时间窗: 6 months
The Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity.
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
时间窗: 6 months
The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.
次要结局
未报告次要终点