Treating Subthreshold Depression in Older Adults in Community-Based Rehab

在社区康复中治疗老年人阈下抑郁症

• 批准号: 7472049
• 负责人: AMY HOROWITZ
• 金额: $ 27.18万
• 依托单位: JEWISH HOME LIFECARE, MANHATTAN
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-14 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7472049
• 关键词: Activities of Daily Living; Address; Adherence; Adult; Age; Amendment; Attention; Caring; Classification; Clinical; Clinical Trials; Communities; Condition; Counseling; Data; Depressed mood; Development; Disabled Persons; Disease remission; Documentation; Drug Formulations; Effectiveness; Elderly; Evaluation; Face; Feasibility Studies; Goals; Hamilton Rating Scale for Depression; Healthcare; High Prevalence; Hour; Impairment; Incentives; Intervention; Lead; Learning; Licensing; Long-Term Effects; Major Depressive Disorder; Manuals; Measures; Mediating; Mental Depression; Mental Health Services; Methods; Minor; Modeling; Modification; Multi-Institutional Clinical Trial; Non-linear Models; Outcome; Participant; Patients; Primary Health Care; Problem Solving; Procedures; Process; Protocols documentation; Provider; Quality of life; Randomized; Rate; Recommendation; Recruitment Activity; Rehabilitation Outcome; Rehabilitation therapy; Relative (related person); Research; Research Design; Research Project Grants; Score; Self Efficacy; Services; Social Workers; Telephone; Time; Training; Vision; Visual impairment; Week; Work; age related; base; clinically significant; comparison group; coping; depressive symptoms; design; disability; interest; minor depressive disorder; multilevel analysis; older patient; programs; rehabilitation service; response; service utilization; size; skills; social; social cognitive theory; subthreshold depression; success; therapy development; treatment effect; volunteer

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.

描述（由申请人提供）：此重新提交申请是响应PAR-06-248：从干预开发到服务：探索性研究补助金（R34）。尽管有大量证据表明，解决问题治疗（PST-PC）在严重抑郁症中的有效性，有些人暗示其可能发生的轻微抑郁症的潜力，但没有工作检查将PST整合到基于社区的老年人康复环境中的可行性，也没有解决对抑郁症的治疗对康复影响的影响。然而，鉴于抑郁症与残疾之间存在良好的牢固关系，以及残疾长老中亚阈值抑郁症及其对康复结果的负面影响，康复环境中的残疾老年患者特别感兴趣。因此，该R34应用的目的是评估PST与视觉残疾长者在基于社区康复的背景下治疗亚阈值抑郁症的可行性和耐受性，以确定是否是否 指示对治疗手册的修改，并获得为开发大规模多站点临床试验所需的初步数据。具体目的是：（1）证明PST实施保真度，包括招聘，接受和遵守协议； （2）确定与以下抑郁症状的抑郁症缓解的主要结果和抑郁症状的临床显着减少的主要结果，（b）康复服务使用的次要结局和临床上的显着减轻，康复服务的次要结果和临床上的降低，以及（c）探索问题的能力和自我抑郁，PST上的抑郁能力和自我提高是否对PST降低了抑郁，PST的潜在抑郁症的主要结局和临床抑郁症状的临床显着减少，（b）康复服务的次要结果，康复服务的次要结局和功能的改善以及（c）探索问题的能力和自我抑制症的抑郁症和自我抑郁症上的抑郁症和自我抑制是否效应，并降低了PST的效果。 （3）基于目标1和2的结果，以进一步完善研究程序和度量，并建立参数（例如，效果大小的估计，损耗率），设计更大规模的临床试验所必需的。有亚阈值抑郁症（轻微抑郁症和/或汉密尔顿抑郁评分量表评分为10或更高）的60名参与者（60岁以上）将被随机分配给治疗（6个1小时的PST课程和常规护理康复）和比较组（通常与社交接触的通常护理康复）。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（多级建模）来检查群体差异，主要结果和次级结果的变化以及中介效应。将特别注意开发大型临床试验设计效果大小的估计值。将评估治疗保真度，包括评估招聘过程，提供者培训，治疗交付和接收以及颁布治疗技能，以确定在设计更大的试验之前需要解决的问题。尽管拟议的研究针对康复中的视力障碍长者的目标，但发现还将为老年康复的更广泛的领域提供信息，在残疾人之间，未经治疗的抑郁症发生率很高。