Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Work and Social Adjustment Scale (WSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Work and Social Adjustment Scale (WSAS)
时间窗: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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.
次要结局
- Insomnia Severity (ISI)(Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only)