Treating Caregiver Stress and Health in Bipolar Disorder

描述（由申请人提供）：迫切需要心理社会干预，以帮助缓解家庭成员照顾双相情感障碍亲属所经历的压力和压力相关的健康和心理健康问题，双相情感障碍是一种影响1%人口的复发性和致残性精神障碍。拟议的研究旨在开发和测试第一种干预措施，以直接针对双相情感障碍患者的照顾者的自我护理缺陷和身心健康受损，以及高感知压力和无效的应对措施。第1-3阶段的治疗开发研究将创建，手动和试点测试健康促进干预（HPI），将有关减轻压力和相关健康和心理健康风险的心理教育与CBT技术相结合，以确定和修改照顾者自我护理的障碍。在第1-2阶段，来自3家研究中心的3名临床研究者组成的团队将制定手册、依从性/能力和结局指标，并运行6个可行性病例。在第3阶段，46名诊断为SCID的双相I型或II型障碍患者的主要照顾者（PC）将随机接受由临床研究者提供的15次HPI，或最多4次自我管理的录像心理教育控制条件（CC）。将在意向治疗设计中，使用多变量回归和/或随机效应模型评价HPI与CC在减轻抑郁和身体健康不良（主要结局）以及护理者负担、焦虑、自我护理/预防缺陷、无效应对和护理者成本（次要结局）方面的疗效。将为更大规模的研究编制培训材料。

DESCRIPTION (provided by applicant): There is a critical need for psychosocial interventions to help alleviate the stress and stress-related health and mental health problems experienced by family members caring for a relative with bipolar disorder, a recurrent and disabling mental disorder affecting 1% of the population. The proposed research aims to develop and test the first intervention to directly target the self-care deficits and compromised mental and physical health of caregivers of patients with bipolar illness, as well as the high perceived stress, and ineffective coping that help promote them. A Stage 1-3 treatment development study will create, manualize and pilot test a health-promoting intervention (HPI) that combines psychoeducation about caregiving stress and associated health and mental health risks with CBT techniques to identify and modify barriers to caregiver self-care. In Stages 1-2 a team of 3 clinical investigators from 3 research sites will develop the manual, adherence/competence and outcome measures, and run 6 feasibility cases. In Stage 3, 46 primary caregivers (PC's) of patients with SCID-diagnosed Bipolar I or II Disorder will be randomized to receive either the 15-session HPI delivered by the clinical investigators, or up to 4 sessions of a self-administered, videotaped psychoeducational control condition (CC). The efficacy of HPI vs. CC in reducing depression and poor physical health (primary outcomes) and caregiver burden, anxiety, self-care/prevention deficits, ineffective coping, and costs to caregivers (secondary outcomes) will be evaluated using multivariate regression and/or random effects models, in an intent-to-treat design. Training materials will be developed for a larger-scale study.