Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Clinical Global Improvement Scale (CGI)-Improvement
研究概览
简要总结
The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. The intervention also focuses on issues specific to transition-age youth. The study includes two phases: In phase 1, the intervention will be developed, refined, and openly piloted with several participants. In phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.
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 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder)
- •ages 18-24 years
- •able to understand the nature of the study as well as potential risks and benefits
- •in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed.
排除标准
- •concurrent cognitive-behavioral psychotherapy
- •documented mental retardation
- •pervasive developmental disorder
- •current serious medical illness
- •inability to participate in the intervention because of acuity of symptoms
- •current drug or alcohol dependence (other than marijuana dependence)
结局指标
主要结局
Clinical Global Improvement Scale (CGI)-Improvement
时间窗: week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-rated change in mood symptoms and overall functioning
feasibility and acceptability
时间窗: post-treatment
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
次要结局
- Self-Control Behavior Schedule(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Adapted Y-BOCS(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Timeline Follow-Back(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Medication history and adherence(baseline, post-treatment, 6 month follow-up)
- High-Risk Sexual Behaviors(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Beck Hopelessness Scale(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Social Adjustment Scale (SAS)(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Barratt Impulsiveness Scale(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Young Mania Rating Scale(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- SCID depression and mania modules(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Adult Suicidal Ideation Questionnaire (ASIQ)(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Hamilton Depression Scale (HAM-D)(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Risky Driving Inventory(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Treatment Satisfaction Questionnaire(post-treatment)
- South Oaks Gambling Screen(baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu)
- Urine Toxicology Screen(baseline, post-treatment, 6 mo follow-up)
研究者
Aude Henin
Co-Director, Child CBT Program
Massachusetts General Hospital