Department of Psychiatry, Rhode Island Hospital, Providence, RI 02903, United States; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI 02912, United States.
Contemp Clin Trials. 2013 Nov;36(2):338-47. doi: 10.1016/j.cct.2013.07.011. Epub 2013 Aug 3.
Family caregivers of individuals with dementia are at heightened risk for emotional and mental health problems. Many caregivers do not seek assistance or become isolated in their caregiving role. Multi-component interventions have demonstrated efficacy for reducing emotional distress and burden, although these approaches are potentially costly and are not widely accessible. In response to these issues, we developed the Family Intervention: Telephone Tracking - Caregiver (FITT-C), which is an entirely telephone-based psychosocial intervention. The purpose of this paper is to describe the study design, methodology, and baseline data for the trial. This study uses a randomized controlled trial design to examine the efficacy of the FITT-C to reduce depressive symptoms and burden in distressed dementia caregivers. All participants (n=250) received a packet of educational materials and were randomly assigned to receive 6 months of the FITT-C intervention or non-directive telephone support. The FITT-C intervention was designed to reduce distress in caregivers and is based on the McMaster Model of Family Functioning, transition theory, and Lazarus and Folkman's Stress and Coping Models. The primary dependent variables were depressive symptoms (Centers for Epidemiological Studies - Depression) and burden (Zarit Burden Interview, Revised Memory and Behavior Problems Checklist - Reaction). Secondary outcome measures included family functioning, self-efficacy, and health-related quality of life. Results of the study will provide important data about the efficacy of a telephone-based approach to reduce distress in dementia caregivers.
痴呆症患者的家庭成员照顾者面临更高的情绪和心理健康问题风险。许多照顾者没有寻求帮助或在照顾角色中孤立无援。多组分干预措施已证明可有效减轻情绪困扰和负担,尽管这些方法可能成本高昂且无法广泛获得。针对这些问题,我们开发了家庭干预:电话跟踪-照顾者(FITT-C),这是一种完全基于电话的心理社会干预措施。本文旨在描述该试验的研究设计、方法和基线数据。这项研究采用随机对照试验设计,以检验 FITT-C 对减轻苦恼的痴呆症照顾者的抑郁症状和负担的疗效。所有参与者(n=250)都收到了一整套教育材料,并随机分配接受 6 个月的 FITT-C 干预或非指导性电话支持。FITT-C 干预旨在减轻照顾者的痛苦,其设计基于麦克马斯特家庭功能模型、过渡理论以及拉扎勒斯和福克曼的压力和应对模型。主要的因变量是抑郁症状(流行病学研究中心抑郁量表)和负担(Zarit 负担访谈、修订后的记忆和行为问题清单-反应)。次要的结果测量包括家庭功能、自我效能和健康相关生活质量。该研究的结果将提供有关基于电话的方法减轻痴呆症照顾者痛苦的疗效的重要数据。