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）：本重新提交申请是对PAR-06-248：从干预开发到服务：探索性研究赠款（R34）的回应。虽然有大量证据表明初级保健问题解决治疗（PST-PC）在重度抑郁症中的有效性，有些人认为它对轻度抑郁症有潜力，但还没有研究将PST纳入老年人社区康复环境的可行性，也没有解决除抑郁症外对康复结果的治疗效果。然而，在康复环境中的残疾老年患者是特别感兴趣的，因为有充分的记录，强大的抑郁症和残疾之间的关系和证据的高患病率的阈值以下抑郁症的残疾老年人及其康复结果的负面影响。因此，这项R34应用的目标是评估PST在社区康复背景下治疗视力残疾老年人阈下抑郁症的可行性和耐受性，以确定 需要对治疗手册进行修改，并获得所需的初步数据，为开展大规模、多中心临床试验提供信息。具体目标是：（1）证明PST实施的可靠性，包括招募、接受和遵守方案;（2）确定PST对患有阈下抑郁症的老年视力受损成人的潜力，相对于：（a）抑郁缓解和抑郁症状临床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）探讨问题解决技能和自我效能是否介导PST对抑郁和次要结局的影响;以及（3）基于目标1&2的结果，进一步完善研究程序和测量并建立参数（例如，估计效应量、损耗率），这是设计更大规模临床试验所必需的。将60名患有阈下抑郁症（轻度抑郁症和/或汉密尔顿抑郁评定量表评分为10分或以上）的受试者（年龄60岁以上）随机分配至治疗组（6次1小时PST疗程和常规护理康复）和对照组（常规护理康复与社会接触）。将在基线、11周（治疗后）和治疗后3个月进行评估。分析将利用分层线性和非线性建模（多水平建模）来检查组间差异、主要和次要结局的变化以及中介效应。将特别注意为大型临床试验的设计开发效应量的估计。将评估治疗保真度，包括评估招募过程、提供者培训、治疗提供和接受以及治疗技能的制定，以确定在设计更大规模的试验之前需要解决的问题。虽然拟议的研究针对康复中的视力受损老年人，但研究结果也将为更广泛的老年康复领域提供信息，其中未经治疗的抑郁症在残疾人群中的比例很高。