Treating Subthreshold Depression in Older Adults in Community-Based Rehab

描述(申请人提供)：此重新提交的申请是对PAR-06-248：从干预开发到服务：探索性研究资助(R34)的回应。虽然有大量证据表明初级护理问题解决疗法(PST-PC)对重度抑郁症有效，一些证据表明它对轻度抑郁症有潜在的作用，但还没有研究将PST整合到老年人社区康复环境中的可行性，也没有研究治疗对抑郁症以外康复结果的影响。然而，康复环境中的残疾老年患者尤其令人感兴趣，因为抑郁症和残疾之间有很好的记录和牢固的关系，而且有证据表明，残疾老年人中有很高的门槛以下抑郁症及其对康复结果的负面后果。因此，R34应用的目的是评估PST治疗视障老年人在基于社区康复的背景下治疗阈值下抑郁症的可行性和耐受性，以确定是否 指出了对治疗手册的修改，并获得了为大规模、多地点临床试验的发展提供信息所需的初步数据。具体目标是：(1)展示PST实施的忠诚度，包括招募、接受和遵守协议；(2)确定PST对患有阈值下抑郁症的老年视障成年人的潜力：(A)抑郁缓解和临床上抑郁症状显著减少的主要结果，(B)康复服务利用和功能能力改善的次要结果，以及(C)是否问题解决技能和自我效能在PST对抑郁和次要结果的影响中起中介作用；以及(3)根据目标1和目标2的结果，进一步改进研究程序和措施，并建立设计更大规模临床试验所需的参数(例如，效应大小的估计、流失率)。60名有阈值以下抑郁症(轻度抑郁症和/或汉密尔顿抑郁量表评分为10或以上)的参与者(年龄60岁以上)将被随机分为治疗组(6次1小时的PST会议和常规护理康复)和对照组(常规护理康复与社会接触)。评估将在基线、11周(治疗后)和治疗后3个月进行。分析将利用分层线性和非线性建模(多水平建模)来检查群体差异、主要和次要结果的变化以及中介效应。将特别注意为设计一项大型临床试验开发效应大小的估计。将对治疗保真度进行评估，包括对招聘程序、提供者培训、治疗提供和接受以及治疗技能的颁布进行评估，以确定在设计更大规模试验之前需要解决的问题。虽然这项拟议的研究以接受康复的视障老年人为目标，但研究结果也将为更广泛的老年康复领域提供信息，在老年康复领域，未经治疗的抑郁症在残疾人群中的比率很高。

DESCRIPTION (provided by applicant): This resubmission application is in response to PAR-06-248: From Intervention Development to Services: Exploratory Research Grants (R34). While there is extensive evidence for the effectiveness of Problem Solving Treatment for Primary Care (PST-PC) in major depression and some suggesting its potential for minor depression, there has been no work examining the feasibility of integrating PST into community-based rehabilitation settings for older adults, nor addressing treatment effects on rehabilitation outcomes in addition to depression. Yet, disabled older patients in rehabilitation settings are of particular interest given the well documented, robust relationship between depression and disability and evidence of the high prevalence of sub-threshold depression among disabled elders and its negative consequences for rehab outcomes. Thus, the goal of this R34 application is to evaluate the feasibility and tolerability of PST with visually disabled elders to treat subthreshold depression within the context of community-based rehabilitation, to determine if modifications to the treatment manual are indicated, and to obtain the preliminary data needed to inform the development of a large-scale, multi-site clinical trial. Specific aims are: (1) to demonstrate PST implementation fidelity including recruitment, acceptance, and adherence to the protocol; (2) to identify the potential of PST for older visually impaired adults with subthreshold depression relative to: (a) primary outcomes of depression remission and clinically significant reductions in depressive symptoms, (b) secondary outcomes of rehabilitation service utilization and improvement of functional ability, and (c) to explore whether problem solving skills and self-efficacy mediate the effect of PST on depression and secondary outcomes; and (3) Based on results from Aims 1&2, to further refine study procedures and measures and establish parameters (e.g., estimates of effect size, attrition rates) necessary for the design of a larger scale clinical trial. Sixty participants (age 60+) with subthreshold depression (minor depression and/or Hamilton Depression Rating Scale score of 10 or greater) will be randomized to treatment (6 1-hour PST sessions and usual care rehab) and comparison groups (usual care rehab with social contact). Assessments will be conducted at baseline, 11 weeks (post-treatment) and 3 months post treatment. Analyses will utilize hierarchical linear and nonlinear modeling (multilevel modeling) to examine group differences, changes in primary and secondary outcomes, and mediating effects. Particular attention will be given to developing estimates of effect size for the design of a large clinical trial. Treatment fidelity will be assessed, including evaluation of the recruitment process, provider training, treatment delivery and receipt, and enactment of treatment skills, in order to identify issues that would need to be addressed prior to the design of a larger trial. While the proposed study targets visually impaired elders in rehabilitation, findings will also inform the broader field of geriatric rehabilitation, where rates of untreated depression are high across disabilities.