Antidepressant Adherence Among Hispanics

西班牙裔人抗抑郁药物的依从性

• 批准号: 6962536
• 负责人: ALEJANDRO INTERIAN
• 金额: $ 15.86万
• 依托单位: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6962536
• 关键词: Hispanic Americans; antidepressants; behavior therapy; behavioral /social science research tag; clinical research; culture; focus groups; handbook; human subject; human therapy evaluation; major depression; motivation; patient oriented research; therapy compliance; therapy design /development

DESCRIPTION (provided by candidate): The proposed research plan seeks to foster the skills necessary for achieving my long-term goal of developing culturally-competent behavioral treatments for Hispanics with major depression and related disorders. In pursuing the necessary skills, the research plan seeks to develop a brief behavioral treatment for improving antidepressant adherence among Hispanic patients. Specifically, a Motivational Interviewing treatment manual will be developed with specific attention to cultural-competence. We are seeking to develop a four session manual and test its ability to improve adherence (i.e., medication-taking behavior) when used as an adjunct to antidepressant therapy. The developmental progression of the proposed research plan was informed by a stage model of behavioral treatment development. The proposed research plan represents the initial phase, which consists of formulating an intervention manual (Phase 1a) and collecting preliminary efficacy data (Phase 1b). Project One (Phase 1a) is geared to provide the candidate with hands-on experience in developing culturally-competent behavioral treatment manuals. Project One will involve collecting qualitative data, via three focus groups, that are relevant to Hispanic groups on the issue of antidepressant adherence. These data will inform the treatment to be developed (4 sessions), so that it addresses adherence in a manner consonant with the attitudes and values of Hispanic populations. Once a preliminary version of the manual is developed, six "test cases" will be treated and subsequently be invited to participate in a focus group to discuss their experience with the intervention. The experiences of these participants will be used to fine-tune the intervention before beginning Project Two. Project Two (Phase 1 b) will provide the candidate with hands-on training for evaluating the efficacy of behavioral treatments. Project Two will examine the Motivational Interviewing manual's preliminary feasibility and efficacy via randomized controlled trial (n = 60). Participants receiving antidepressant treatment will be randomized to receive the Motivational Interviewing intervention (n=30), as an adjunct to antidepressant therapy and treatment-as-usual, or a treatment-as-usual control group (n=30). Both groups will be compared on their antidepressant adherence to generate an effect size of the treatment. Antidepressant adherence will be measured using the Medication Event Monitoring System (MEMS). The MEMS is a medication container, whose cap contains a microchip. The MEMS records the whether medications are correctly taken over a period of time. Project Two will also conduct analyses to evaluate whether a model of adherence mediates the outcome of the behavioral treatment. If promising, the preliminary data generated will be used to seek R01 funding for a Phase II clinical trial.

描述（由候选人提供）：拟议的研究计划旨在促进我实现我长期目标的必要技能，以开发具有重大抑郁症和相关疾病的西班牙裔的具有文化竞争的行为治疗。在追求必要的技能时，该研究计划旨在制定短暂的行为治疗，以改善西班牙裔患者的抗抑郁剂依从性。具体而言，将开发动机访谈治疗手册，以特别关注文化能力。当用作抗抑郁治疗的辅助手册时，我们正在寻求制定四次会话手册，并测试其提高依从性（即服药行为）的能力。 拟议的研究计划的发展进展是由行为治疗发展的阶段模型所告知的。拟议的研究计划代表了初始阶段，该阶段包括制定干预手册（第1A阶段）并收集初步疗效数据（第1B阶段）。项目第一（第1A期）旨在为候选人提供在开发具有文化竞争性行为治疗手册的动手经验。项目第一将涉及通过三个焦点小组收集与西班牙裔小组有关抗抑郁剂依从性问题的定性数据。这些数据将告知要开发的治疗方法（4个课程），以便以与西班牙裔人群的态度和价值相吻合的方式解决依从性。一旦开发了手册的初步版本，将对待六个“测试用例”，并随后邀请参加焦点小组，讨论他们在干预方面的经验。这些参与者的经验将用于在开始第二个项目之前对干预进行微调。 项目第二（第1阶段B）将为候选人提供动手培训，以评估行为治疗的功效。项目第二将通过随机对照试验（n = 60）研究动机采访手册的初步可行性和功效。接受抗抑郁治疗的参与者将被随机分配，以接受动机访谈干预措施（n = 30），作为抗抑郁药治疗和治疗态度的辅助手段，或者是平常的对照组（n = 30）。将对两组的抗抑郁药依从性进行比较，以产生治疗的效果大小。将使用药物事件监测系统（MEMS）测量抗抑郁药依从性。 MEMS是一个药物容器，其帽子包含一个微芯片。 MEMS记录了是否在一段时间内正确服用药物。第二个项目还将进行分析，以评估一种依从性模型是否介导了行为治疗的结果。如果有希望，生成的初步数据将用于寻求II期临床试验的R01资金。