A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Changes in Consensus Sleep Diary (CSD)
研究概览
简要总结
The proposed study is a multiple baseline design pilot study which seeks to evaluate the impact of digitally administered CBT-I, using the Sleepio platform, for the treatment of insomnia disorder among Veterans with co-morbid psychopathology. In addition, information related to acceptability and feasibility of the intervention among a Veteran sample will be obtained.
详细描述
Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the front-line intervention for individuals with insomnia and has recently been rolled-out throughout the Veterans Health Administration (VHA; Manber et al., 2012). CBT-I includes behavioral (sleep restriction, stimulus control, relaxation exercises), cognitive (cognitive restructuring, mindfulness exercise), and psychoeducation (sleep hygiene) components. While CBT-I has been demonstrated to be a highly efficacious and effective intervention, it is a specialized intervention that can be costly and is in limited supply based on the level of training required and number of providers available. For this reason, digital administration of CBT-I has been examined and research has demonstrated initial efficacy among community samples (Ritterband et al., 2009; Vincent et al., 2009; Espie et al., 2012), with one platform, Sleepio, demonstrating efficacy compared to a placebo intervention (Espie et al., 2012; Espie et al., 2014). For this reason, the current study will utilize the Sleepio platform which provides an interactive, customized and tailored delivery of CBT-I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be:
- •at least 18 years of age (no upper age limit)
- •meet DSM-5 defined criteria for insomnia disorder
- •be on a stable dose of any prescription medication (including sleep medication) for at least 2 weeks prior to the in-person screening assessment
- •have comorbid psychopathology (i.e., symptoms of Posttraumatic Stress Disorder (PTSD), anxiety, and/or depression)
排除标准
- •limited mental competency (not oriented to person, place, or time) and the inability to give informed, voluntary, or written consent to participate
- •high risk for sleep apnea (STOP-Bang score >/= 3)
- •current or previous diagnosis of sleep apnea that is untreated
- •history of moderate or severe Traumatic Brain Injury
- •current substance or alcohol use disorder, moderate to severe, in the past 3 months
- •current bipolar disorder
- •current or lifetime psychotic disorders
- •seizure disorders
- •moderate to high risk of suicide in the past month
结局指标
主要结局
Changes in Consensus Sleep Diary (CSD)
时间窗: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
The CSD (Carney et al., 2012) will be used to monitor self-reported sleep during the baseline phase, over the course of the digitally administered CBT-I intervention, and throughout follow-up. The CSD is a standardized sleep diary based on expert consensus and qualitative patient input.
Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms
时间窗: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
This unpublished measure requests information on the participants impressions of using digitally administered CBT-i. Questions ask about the following areas: 1) Use of the digitally administered intervention including general impressions and frequency of use, 2) Perceived value and helpfulness of the digitally administered intervention including which features of the program were perceived to be most useful and how the program impacted different aspects of insomnia and management of insomnia, 3) Impact on health (e.g., perceived impact on management of insomnia), 4) Potential enhancements (i.e. recommendations for improvements to the intervention).
Changes in the Insomnia Severity Index (ISI)
时间窗: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up)
The ISI is used to assess self-reported insomnia severity (Bastien et al., 2001). It is a 7-item self-report scale assessing sleep problem severity over the last two weeks, rated on a 5-point scale from 0 to 4; a higher score indicates higher severity. The ISI sums scores on the 7 items (1a, 1b, 1c, 2, 3, 4, 5) for a total score range of 0 to 28.
次要结局
- Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)(0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up))
- Changes in The Posttraumatic Checklist-5 (PCL-5)(0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up))
- Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)(0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up))
- Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)(0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up))
研究者
Shannon McCaslin
Clinical Psychologist
Palo Alto Veterans Institute for Research