Brief Behavioral Insomnia Treatment Study (BBTI)
2020年1月28日 更新者：VA Office of Research and Development
Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.
研究概览
详细说明
This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder.
The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome.
Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.
研究类型
介入性
注册 (实际的)
93
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
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California
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San Francisco、California、美国、94121
- San Francisco VA Medical Center, San Francisco, CA
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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
18年 至 75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:
- Veterans between the ages of 18-75 years.
- Meet DSM-5 Criteria for Insomnia Disorder.
- Able attend in-person appointments at the San Francisco VA Medical Center
The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
- Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.
- However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
- The investigators will not exclude individuals with TBI.
- The investigators will not exclude individuals with chronic pain.
- The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.
Exclusion Criteria:
- Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
- Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
- Veterans with suicidal or homicidal ideation.
- Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
- Veterans who work night or rotating shifts.
- Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).
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 |
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实验性的：Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI).
BBTI consists of two in-person sessions, with the two other sessions conducted via telephone.
BBTI emphasizes behavioral elements of insomnia treatment.
Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles.
Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
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Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI).
BBTI consists of two in-person sessions, with the two other sessions conducted via telephone.
BBTI emphasizes behavioral elements of insomnia treatment.
Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles.
Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
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有源比较器：Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT).
PMRT consists of two in-person and two phone sessions.
Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises.
Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
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Participants will receive 4 weeks of progressive muscle relaxation training (PMRT).
PMRT consists of two in-person and two phone sessions.
Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises.
Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
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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 |
|---|---|---|
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Work and Social Adjustment Scale (WSAS)
大体时间：Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Scores range from 0-40, with higher scores meaning greater impairment.
The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
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Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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Work and Social Adjustment Scale (WSAS)
大体时间：Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Scores range from 0-40, with higher scores meaning greater impairment.
The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
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Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Insomnia Severity (ISI)
大体时间：Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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The ISI is a specific index of perceived insomnia severity.
Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
Scores range from 0-28, with higher scores meaning greater impairment.
The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
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Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
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Insomnia Severity (ISI)
大体时间：Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity.
Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
Scores range from 0-28, with higher scores meaning greater impairment.
The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
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Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.
- Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.
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 (实际的)
2016年1月6日
初级完成 (实际的)
2019年3月31日
研究完成 (实际的)
2019年6月30日
研究注册日期
首次提交
2015年10月2日
首先提交符合 QC 标准的
2015年10月6日
首次发布 (估计)
2015年10月8日
研究记录更新
最后更新发布 (实际的)
2020年2月7日
上次提交的符合 QC 标准的更新
2020年1月28日
最后验证
2020年1月1日
更多信息
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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