RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts
Condition: Insomnia; Suicidal Ideation
MeSH terms: Sleep Initiation and Maintenance Disorders; Suicidal Ideation
Study type: Interventional

Summary: 
      There is a strong association between insomnia and suicidal thoughts and behaviors. Insomnia
      also frequently co-occurs with other common conditions associated with suicide such as
      depression and posttraumatic stress disorder. This project focuses on improving sleep as a
      novel suicide prevention strategy that can be delivered to a broad range of Veterans. The
      study will examine how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment
      for insomnia, may reduce suicidal thoughts in Veterans who also suffer from co-occurring
      conditions when delivered by integrated primary care clinicians.
    

Detailed description: 
      Anticipated Benefit to VA Healthcare The proposed study will establish the feasibility and
      effectiveness of treating insomnia in the primary care environment as a suicide prevention
      strategy. By 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
      posttraumatic stress disorder (PTSD), the investigators expect to reduce the severity of
      suicidal ideation (SI) among Veterans experiencing SI, insomnia and a co-occurring condition.

      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 and depression 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 leaving them at
      higher risk for suicide.

      This application builds upon VA HSR&D funded pilot work that demonstrated the feasibility of
      delivering a brief version of cognitive-behavioral therapy for insomnia (CBT-I) within
      primary care to Veterans experiencing SI. The pilot data suggest that the investigators'
      brief, primary-care based insomnia treatment was delivered with high fidelity, acceptable to
      Veterans and associated with significant reductions in insomnia and depression symptoms, and
      reduced SI intensity. The next stage of this program of research is to establish the
      feasibility of delivering the brief, primary care based, insomnia intervention utilizing
      primary care-mental health integration (PC-MHI) clinicians (as opposed to research staff) and
      to establish the effectiveness of the intervention on reducing the severity of factors that
      contribute to suicide risk and to improve other clinical markers in a definitive trial.

      Project Objectives The ultimate goal of the broader program of research is to reduce suicide
      among Veterans by intervening upon sleep disturbance as a modifiable risk factor for suicide.
      In this application the investigators focus on insomnia, which is the most common sleep
      disorder among Veterans and is robustly associated with suicidal thoughts and behaviors.

      The primary objective of this proposed clinical trial is to test whether (and how) using
      brief behavioral insomnia treatment can not only improve sleep, but reduce other risk factors
      for suicide including the severity of depression, PTSD and suicidal ideation among Veterans
      at risk for suicide. Secondary objectives are to: (1) gather initial data on barriers and
      facilitators to implementation to aid future implementation efforts in VA primary care and
      (2) determine if the intervention improves attitudes towards psychotherapy treatments that
      address the co-morbid conditions.

      Project Methods In order to achieve these objectives the investigators will conduct a
      real-world, randomized clinical trial among 240 Veterans experiencing either co-occurring
      depression or PTSD recruited from primary clinics at three VA sites. These Veterans, who will
      also endorse SI and insomnia, will be randomized to receive either a brief course of CBT-I or
      a sleep hygiene intervention of similar length. Assessments of suicidal thoughts and
      behaviors, insomnia, depression, and PTSD will be conducted at baseline, post-treatment, and
      every 6 weeks thereafter until 6 months post-treatment. Mixed effects modeling and structured
      equation modeling will be applied to determine how improvements in sleep and other symptoms
      (e.g. depression, PTSD) contribute to reductions in SI severity. In addition, the
      investigators will collect, code and analyze participant and provider feedback to assess
      barriers and facilitators of implementation in real-world clinical practice.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia; Sleep Hygiene
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.; The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel study arms: (1) cognitive behavioral therapy for insomnia (the experimental condition) and (2) sleep hygiene (the control condition).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia; suicidal ideation; depression; posttraumatic stress disorder; cognitive behavioral therapy for insomnia; sleep; suicide