Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)
Condition: Insomnia; Depression; Posttraumatic Stress Disorder; Suicidal Ideation
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Stress Disorders, Post-Traumatic; Suicidal Ideation
Study type: Interventional

Summary: 
      There is a strong association between sleep disturbance and suicidal thoughts and behaviors.
      Sleep disturbance is also highly comorbid with other common conditions associated with
      suicide such as depression and posttraumatic stress disorder. Accordingly, this application
      focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a
      broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral
      Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in
      Veterans who also suffer from additional conditions. The proposal further suggests that
      adding this sleep intervention to usual care may further enhance overall care by increasing
      the utilization of recommended treatments for depression and posttraumatic stress disorder.
    

Detailed description: 
      Anticipated Benefit to VA Healthcare The proposed study will establish proof of concept that
      suicidal ideation can be reduced by adjunctively treating insomnia, a common problem that is
      both a risk factor for suicide and highly prevalent in common conditions associated with
      suicide such as depression and PTSD. In addition, to the extent that insomnia is improved,
      the investigators expect to both enhance Veteran's quality of life and increase their
      engagement with treatments for co-occurring conditions.

      Project Background Suicide is the tenth leading cause of death in the U.S., is a major
      concern of the Department of Veterans Affairs (VA), and occurs at elevated rates among
      Veterans. Veterans with common chronic conditions such as PTSD, depression, substance abuse
      and chronic pain are at increased risk for suicide. Although evidence-based treatments exist
      for these conditions, a significant number of Veterans do not engage in or complete such
      treatments. This application focuses on an intervention target that co-occurs in each of the
      listed conditions at high rates and is itself an independent risk factor for suicidal
      thoughts and behaviors: the sleep disturbance of insomnia. Therefore, this proposal examines
      the use of cognitive-behavioral therapy for insomnia (CBT-I), an efficacious intervention
      that targets insomnia, as a novel way to reduce suicidal ideation in at-risk Veterans.
      Importantly, CBT-I has been successfully used in patients with PTSD and depression.
      Preliminary evidence from an uncontrolled trial in civilians suggests that CBT-I may also
      decrease suicidal ideation, but this has not been tested in Veterans, in the context of
      treatments for co-occurring conditions, or in a controlled trial.

      Project Objectives The ultimate goal of the broader program of research is to reduce suicide
      among Veterans, while the proposed pilot project will provide data to guide the development
      of a larger trial. The primary objectives of this pilot project are to test whether using
      CBT-I as an adjunctive treatment: (1) is feasible to deliver in the context of other ongoing
      care and acceptable to participants; (2) can reduce the severity of suicidal ideation among
      Veterans at risk for suicide; and (3) can increase rates of engagement in treatments that
      address the co-morbid conditions that also put them at risk for suicide. The latter objective
      will help refine the study methods, design, and intervention in anticipation of a larger
      trial.

      Project Methods In order to achieve these proof-of-concept objectives the investigators will
      conduct a small randomized clinical trial. Veterans who are either flagged as high risk for
      suicide or who have depression or PTSD will be recruited from VA sites only. Approximately 56
      such Veterans who also endorse current suicidal ideation and current insomnia will be
      randomized to receive either treatment-as-usual or a 4-session CBT-I treatment in addition to
      treatment-as-usual. All participants will be encouraged to continue or to seek treatment for
      co-occurring conditions as recommended by their VA treatment providers. Assessments of
      suicidal ideation, insomnia, depression, PTSD, and quality of life will be conducted at
      baseline and following the treatment period. In addition, the investigators will collect
      provider and participant feedback at an exit interview immediately following the
      post-treatment assessment. The investigators will use multiple linear and logistic regression
      models to assess the effect of treatment on outcome measures across the study assessment time
      points.
    

Intervention name(s): CBT-I; TAU
Intervention type(s): Behavioral; Other
Intervention description(s): Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.; Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: sleep disorders; insomnia; suicidal ideation; Depression; Depressive disorders; PTSD; anxiety disorders; suicide; cognitive behavioral therapy