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Cognitive Therapy for Suicidal Older Men

2017年6月7日 更新者:University of Pennsylvania
The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.

研究概览

详细说明

Older adult males have the highest suicide rate of any age group in the U.S. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation.

Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enhanced usual care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.

研究类型

介入性

注册 (实际的)

110

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Aaron T. Beck Psychopathology Research Center - University of Pennsylvania

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
  2. Male
  3. 50 years of age or older
  4. Able to speak English
  5. Able to provide written informed consent
  6. Able to attend study assessment and therapy sessions
  7. Able to provide at least two verifiable contacts for tracking purposes
  8. Able to function at an intellectual level to allow for the reliable completion of study assessments and participate in psychotherapy as indicated by a Mini-Mental Status Exam (MMSE) total score of 24 or higher and an Executive Interview (EXIT-25) total score of 14 or lower.

Exclusion Criteria:

  1. Needed priority treatment for a substance use disorder as determined by the referring clinician.
  2. Needed priority treatment for PTSD as determined by the referring clinician.
  3. Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
有源比较器:Enhanced Usual Care
Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists.
Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in baseline suicidal ideation
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months

次要结果测量

结果测量
措施说明
大体时间
depression
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
hopelessness
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
quality of life
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
social problem solving skills
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
complicated grief
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
reasons for living and dying
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
perceived social support
大体时间:baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
Cognitive Executive Functioning
大体时间:baseline, 1, 3, 6, 9, 12 months
Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.
baseline, 1, 3, 6, 9, 12 months

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。

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

2011年9月1日

初级完成 (实际的)

2017年4月6日

研究完成 (实际的)

2017年4月6日

研究注册日期

首次提交

2011年8月25日

首先提交符合 QC 标准的

2012年2月14日

首次发布 (估计)

2012年2月17日

研究记录更新

最后更新发布 (实际的)

2017年6月8日

上次提交的符合 QC 标准的更新

2017年6月7日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R01MH086572-01A2 (美国 NIH 拨款/合同)
  • 1R01MH086572-01A2 (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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