Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
研究概览
简要总结
Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.
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
- None
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5)
- •Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month
- •If < 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if > 18 years, able and willing to provide written informed consent
- •Fluent in English
排除标准
- •Unable to receive care in the outpatient setting due to illness severity
- •A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder
- •Documented or suspected IQ < 70
- •Prior enrollment in CAE or Phase 2
- •Have recently (in the past month) started a new psychotherapy/behavioral intervention
研究组 & 干预措施
Customized Adherence Enhancement for AYA
This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA).
干预措施: Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) (Behavioral)
Enhanced Treatment as Usual (ETAU)
This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).
干预措施: Enhanced Treatment as Usual (ETAU) (Behavioral)
结局指标
主要结局
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
时间窗: Baseline and 24 weeks
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks
时间窗: Baseline and 24 weeks
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks
时间窗: Baseline and 24 weeks
A special pill cap/box will record the time/date of bottle opening. A dose will be counted as "taken" if the bottle is opened within two hours of the prescribed time. A percent of doses taken (treatment adherence) will be calculated by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
次要结局
未报告次要终点
研究者
Martha Sajatovic, MD
Professor
Case Western Reserve University