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临床试验/NCT03203720
NCT03203720已完成不适用

Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Objective Medication Adherence

研究概览

简要总结

Adolescence is the peak onset period for serious and persistent psychiatric disorders. Treatment guidelines for management of major psychiatric disorders in youth include pharmacotherapy. There has been substantial progress in recent years in identifying effective medications for youth with psychiatric disorders. However, adherence to prescribed medications among psychiatric populations is notoriously low, and adolescents rank among the least adherent of all patient populations. Given that the consequences of poor medication adherence among youth with chronic mental illness are far-reaching, including hospitalization, poor functioning, and suicide, there is a desperate need for interventions targeting medication adherence in this population.

详细描述

Adolescence is the peak period of onset for serious and persistent psychiatric disorders. Treatment guidelines for the management of major psychiatric disorders in adolescence indicate pharmacotherapy is a critical element of effective treatment. Unfortunately, adolescence is a particularly vulnerable window for poor medication adherence, and little is known about the timecourse and specific factors associated with poor medication adherence in this population. Given that the consequences of poor medication adherence among youth with chronic mental illness are far-reaching, and include hospitalization, profound functional impairment and even suicide, there is a desperate need for interventions targeting medication adherence in this population. Motivational Interviewing (MI) is an evidence-based approach focused on enhancing motivation for change. This model holds great promise for improving medication adherence in adolescents with psychiatric disorders because it is developmentally sensitive, acceptable to patients and providers, and readily disseminable across clinical settings. Research demonstrates that brief motivational interventions (BMIs) utilizing a MI approach result in improved treatment adherence among youth with a variety of chronic medical conditions. Although widely applied for adolescent substance use behaviors, BMIs have yet to be examined for improving medication adherence in youth with severe psychiatric disorders. Adolescents with bipolar disorder (BP) are an ideal population with whom to develop a BMI for medication adherence because adolescents with BP are among the least adherent of any psychiatric population. Experience developing a BMI for this challenging population will directly inform intervention for youth with a range of chronic psychiatric disorders. The purpose of the proposed study is to conduct a small randomized trial comparing CABS Standard Care (SC) augmented with the BMI versus SC alone. Outcomes will be assessed monthly over 6 months. Participants will include 40 adolescents with BP. This approach is in direct accord with the National Institute of Mental Health (NIMH) Strategic Plan in which the development and testing of innovative interventions to reduce risk and positively alter trajectories of mental illness are informed by research findings regarding robust and malleable risk factors. Research in this area is of great public health importance, as it has the potential to lessen costs, disrupt the cycle of poor outcomes, and minimize the long-term debilitating effects of these serious disorders.

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)

盲法说明

Outcomes assessors blind to treatment group of participants.

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 12 years, 0 months to 22 years, 11 months;
  • a diagnosis of BP spectrum disorder via semi-structured interview;
  • willing to engage in treatment at the BP specialty clinic;
  • English fluency and understanding, as the study consists of interviews and surveys that necessitate English fluency and understanding;
  • able and willing to give informed consent/assent to participate.

排除标准

  • evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by semi-structured interview, parent report, medical history, or school records;
  • a life-threatening medical condition requiring immediate treatment;
  • current victim of sexual or physical abuse.

结局指标

主要结局

Objective Medication Adherence

时间窗: 6 months

Medication adherence via electronic pillbox

Subjective Medication Adherence

时间窗: 6 months

Self-reported medication adherence

次要结局

  • Mood disorder symptoms(Quarterly over 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tina R Goldstein

Associate Professor

University of Pittsburgh

研究点 (2)

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