Treatment Adherence Enhancement in Bipolar Disorder

描述(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、高自杀率和高昂的经济成本有关。尽管治疗BD的方法激增，但由于药物治疗依从性不佳，近一半的BD患者没有从药物治疗中受益。不坚持BD药物治疗会显著恶化结果。BD患者不依从性的原因是多方面的，有人建议，如果干预措施特别针对对特定个体重要且可修改的因素，依从性增强可能效果最好。尽管问题很严重，但关于改善治疗依从性的干预措施的文献令人惊讶地有限。迫切需要采取干预措施，以提高BD患者的治疗依从性：1)未来治疗不依从性的高风险；2)可能无法获得或对长期、高强度和专门护理感兴趣；3)灵活和以患者为中心，同时考虑到特定个人不遵守治疗的原因。这项拟议的研究建立在研究人员在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。调查人员已经将CAE干预措施手册化，以供通常出现在公共部门精神卫生环境中的工作人员使用。这些研究人员的试点工作表明，CAE可以提高服药依从性，减少BD症状，并改善依从性差的BD患者的功能状态。这些初步发现为下一个适当的步骤奠定了基础，即在前瞻性随机对照试验(RCT)中，将CAE干预与广泛定向的非个性化教育(EDU)进行比较测试。这项拟议的研究是有史以来第一次专门关注BD治疗依从性增强的随机对照试验，将测试CAE是否与EDU相比改善依从性和精神健康结果。拟议研究的一个独特特点是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促进对健康结局不佳风险最大的BD患者的护理，预计研究结果将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.