Treatment Adherence Enhancement in Bipolar Disorder

增强双相情感障碍的治疗依从性

• 批准号: 8289100
• 负责人: Martha X Sajatovic
• 金额: $ 57.82万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-19 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8289100
• 关键词: Accounting; Address; Adherence; Adverse effects; Advocate; Anticonvulsants; Antipsychotic Agents; Area; Attitude; Award; Behavior; Behavioral; Bipolar Disorder; Caring; Chronic; Clinical; Clinical Trials Design; Comorbidity; Databases; Development; Education; Environment; Family; Financial cost; Foundations; Funding; Future; Grant; Guidelines; Health; Impairment; Individual; Industry; Intervention; K-Series Research Career Programs; Knowledge; Literature; Lithium; Maps; Mental Health; Mental disorders; Methodology; Methods; Minority; Moods; National Institute of Mental Health; Outcome; Patients; Pharmaceutical Preparations; Pharmacotherapy; Provider; Psychopathology; Psychosocial Factor; Public Health; Public Sector; Publications; Publishing; Qualitative Evaluations; Quality of life; Randomized Controlled Trials; Relapse; Reporting; Research; Research Personnel; Resources; Risk; Safety; Self Efficacy; Staging; State Government; Step Tests; Stigmata; Strategic Planning; Symptoms; Testing; Time; Work; atypical antipsychotic; base; brief intervention; evidence base; expectation; experience; flexibility; functional outcomes; functional status; high risk; improved; interest; medical specialties; medication compliance; pressure; prospective; psychosocial; secondary outcome; social; social stigma; substance abuse treatment; suicide rate; therapy development; treatment adherence

DESCRIPTION (provided by applicant): Bipolar disorder (BD) is a serious and chronic mental illness that is associated with substantial impairment in quality of life and functional outcomes, high rates of suicide, and high financial costs. In spite of a proliferation of treatments for BD, nearly half of individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication treatment adherence. Non-adherence with BD medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that adherence enhancement might work best if the intervention specifically addresses factors that are important and modifiable for a specific individual. In spite of the enormity of the problem, the literature on interventions to improve treatment adherence is surprisingly limited. There is an urgent need for interventions to enhance treatment adherence among BD patients that: 1) are at high risk for future treatment non-adherence; 2) may not have access to or interest in long-term, high-intensity, and specialized care; and 3) are flexible and patient-focused taking into account reasons for non-adherence for a specific individual. The proposed study builds upon the investigator's extensive body of work in BD treatment adherence, and development of a customized adherence enhancement (CAE) psychosocial approach that is brief, efficient, and practical. The investigators have manualized the CAE intervention for intended use by staff that might typically be present in public-sector mental health settings. Pilot work by these investigators suggests that CAE can improve medication treatment adherence, reduce BD symptoms and improve functional status in poorly adherent BD patients. These preliminary findings have set the stage for the next appropriate step, which is testing of the CAE intervention compared to broadly-directed, non-individualized education (EDU) in a prospective, randomized controlled trial (RCT). The proposed study is a first-ever RCT focused specifically on BD treatment adherence enhancement, and will test whether CAE improves adherence and mental health outcomes compared to EDU. A unique feature of the proposed study is a supplemental and complementary qualitative evaluation that will inform future intervention refinements. Taken together, the proposed project has the potential to greatly advance the care of BD patients who are at greatest risk for poor health outcomes, with findings expected to be generalizable across a variety of treatment settings. PUBLIC HEALTH RELEVANCE: The proposal will test a brief, tailored intervention intended to improve medication treatment adherence in high-risk patients with bipolar disorder. Given the enormous personal and societal burden of non-adherence on patients and families, the proposal has substantial public health implications.

描述（由申请人提供）：双相情感障碍（BD）是一种严重的慢性精神疾病，与生活质量和功能结局的严重损害、高自杀率和高经济成本相关。尽管BD的治疗方法越来越多，但由于药物治疗依从性不佳，近一半的BD患者无法从药物治疗中获益。BD药物治疗的不依从性显著影响结局。BD患者不依从的原因是多方面的，有人建议，如果干预措施专门针对特定个体重要且可改变的因素，则依从性增强可能会发挥最佳作用。尽管问题的复杂性，文献干预措施，以提高治疗依从性是令人惊讶的有限。迫切需要干预措施来提高BD患者的治疗依从性，这些患者：1）未来治疗不依从的风险高; 2）可能无法获得或不感兴趣长期，高强度和专业护理; 3）考虑到特定个体不依从的原因，灵活且以患者为中心。拟议的研究建立在研究者在BD治疗依从性方面的广泛工作基础上，并开发了一种简短、有效和实用的定制依从性增强（CAE）心理社会方法。研究人员已经将CAE干预手动化，供通常可能存在于公共部门心理健康环境中的工作人员使用。这些研究者的试点工作表明，CAE可以改善药物治疗依从性，减少BD症状，改善依从性差的BD患者的功能状态。这些初步研究结果为下一步的适当步骤奠定了基础，即在前瞻性随机对照试验（RCT）中测试CAE干预与广泛指导的非个性化教育（EDU）的比较。这项拟议的研究是有史以来第一个专门关注BD治疗依从性增强的RCT，并将测试与EDU相比，CAE是否能改善依从性和心理健康结局。拟议研究的一个独特之处是补充和补充定性评价，将为未来的干预措施改进提供信息。总的来说，拟议的项目有可能大大推进BD患者的护理，这些患者的健康状况最差，预计研究结果将在各种治疗环境中推广。 公共卫生关系：该提案将测试一种简短的、量身定制的干预措施，旨在改善双相情感障碍高危患者的药物治疗依从性。鉴于不遵守对患者和家庭造成的巨大个人和社会负担，该提案具有重大的公共卫生影响。