Treatment Adherence Enhancement in Bipolar Disorder

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果的严重损害、高自杀率和高经济成本相关。尽管双相障碍的治疗方法越来越多，但由于药物治疗依从性不佳，近一半的双相障碍患者没有从药物治疗中获益。不坚持双相障碍药物治疗会显著恶化预后。双相障碍患者不依从性的原因是多方面的，有研究表明，如果干预措施专门针对对特定个体重要且可改变的因素，则依从性增强可能效果最好。尽管这个问题非常严重，但关于提高治疗依从性的干预措施的文献却令人惊讶地有限。目前迫切需要采取干预措施来提高BD患者的治疗依从性，这些患者：1)未来治疗不依从性风险高；2)可能没有机会或兴趣接受长期、高强度和专门的护理；3)灵活和以患者为中心，考虑到特定个体不遵守规定的原因。拟议的研究建立在研究者在双相障碍治疗依从性方面的广泛工作基础上，并开发了一种定制的依从性增强（CAE）社会心理方法，该方法简短、有效、实用。研究人员已将CAE干预措施手工化，以供公共部门精神卫生机构的工作人员使用。这些研究人员的试点工作表明，CAE可以改善依从性差的BD患者的药物治疗依从性，减轻BD症状并改善功能状态。这些初步发现为下一步奠定了基础，即在一项前瞻性随机对照试验（RCT）中，将CAE干预与广泛指导的非个性化教育（EDU）进行比较。该研究是首个专门关注双相障碍治疗依从性增强的随机对照试验，并将测试CAE与EDU相比是否能改善依从性和心理健康结果。拟议研究的一个独特之处在于补充和补充定性评估，这将为未来的干预改进提供信息。综上所述，拟议的项目有可能极大地推进对健康状况不佳风险最大的双相障碍患者的护理，研究结果有望在各种治疗环境中推广。

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.