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Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)

2015年11月30日 更新者:University of Alabama, Tuscaloosa

Insomnia and depression are two of the most prevalent mental health disorders and often co-occur.

Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources.

The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.

研究概览

研究类型

介入性

注册 (预期的)

46

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Tuscaloosa、Alabama、美国、35487
        • UATuscaloosa

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 50 years of age or older,
  • resident of the Black Belt or adjacent counties and receiving services from one of our primary care collaborators
  • absence of significant cognitive impairment as indicated by a score of 24 or higher (17 or higher for those with only an eighth grade education) on the Mini-Mental Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975
  • not currently receiving psychological treatment,
  • absence of serious suicidality
  • concurrent psychiatric/medical disorders are not automatic disqualifiers unless they prevent participants from attending CBT therapy sessions or impede data collection,
  • a referral from their primary care physician indicating presence of both insomnia and depression symptoms of sufficient significance to warrant initiation or continuance of primary care treatment for newly emergent or residual symptoms. Persons who are currently receiving pharmacotherapy for insomnia and/or depression must evidence residual symptoms of both disorders of sufficient magnitude to be evaluated as clinically significant and warranting further treatment by their primary care physician.

Exclusion Criteria:

  • age is below 50
  • not receiving services from one of our primary care collaborators
  • significant cognitive impairment is present as indicated by a score of 23 or lower (16 or lower for those with only an eighth grade education) on the MMSE
  • currently receiving psychological treatment
  • presence of serious suicidality
  • intrusive and unstable concurrent psychiatric/medical disorders
  • primary care physician declines to refer

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
有源比较器:Treatment as Usual
No additional treatment besides regular care.
Standard Care - Treatment as usual

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Insomnia Severity Index
大体时间:3-month follow-up (23weeks post-treatment)
Insomnia Measure
3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale
大体时间:10 weeks Post-treatment
Depression measure
10 weeks Post-treatment
Hamilton Depression Scale
大体时间:3 Month follow-up (23 weeks post treatment)
Depression Measure
3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index
大体时间:10 weeks Post-treatment
Insomnia Measure
10 weeks Post-treatment

次要结果测量

结果测量
措施说明
大体时间
GDS
大体时间:Pre-Treatment (Baseline/Week 0)
Self-reported Geriatric Depression Scale
Pre-Treatment (Baseline/Week 0)
SOL
大体时间:Pre-Treatment (Baseline/Week 0)
self-reported Sleep Onset Latency
Pre-Treatment (Baseline/Week 0)
WASO
大体时间:Pre-Treatment (Baseline/Week 0)
Wake-time After Sleep Onset
Pre-Treatment (Baseline/Week 0)
SOL
大体时间:10 weeks Post-treatment
Self-reported Sleep onset latency
10 weeks Post-treatment
SOL
大体时间:3-month follow-up (23weeks post-treatment)
Self-reported Sleep onset latency
3-month follow-up (23weeks post-treatment)
GDS
大体时间:10 weeks Post-treatment
Self Reported Geriatric Depression Scale
10 weeks Post-treatment
GDS
大体时间:3-month follow-up (23weeks post-treatment)
Self-reported Geriatric Depression Scale
3-month follow-up (23weeks post-treatment)
WASO
大体时间:10 weeks Post-treatment
Wake-time After Sleep Onset
10 weeks Post-treatment
WASO
大体时间:3-month follow-up (23weeks post-treatment)
Wake-time After Sleep Onset
3-month follow-up (23weeks post-treatment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kenneth L. Lichstein, Ph.D.、University of Alabama, Tuscaloosa
  • 首席研究员:Forrest Scogin, Ph.D.、University of Alabama, Tuscaloosa

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年6月1日

初级完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2012年6月26日

首先提交符合 QC 标准的

2012年7月19日

首次发布 (估计)

2012年7月24日

研究记录更新

最后更新发布 (估计)

2015年12月2日

上次提交的符合 QC 标准的更新

2015年11月30日

最后验证

2015年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 10-0309
  • 1R34MH086643-01A2 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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