Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress
Condition: Stress Disorders, Post-Traumatic; Depression; Sleep
MeSH terms: Depression; Depressive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary purpose of this study is to test whether and how cognitive-behavioral therapy for
      insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly
      improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms.
      The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on
      symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and to
      assess the role of neurobiological processes and sleep architecture in mediating treatment
      outcomes.
    

Detailed description: 
      Posttraumatic Stress Disorder (PTSD), which occurs in at least 15-20% of individuals exposed
      to a traumatic event, is a chronic condition associated with the development of a multitude
      of negative physical and mental health consequences and the co-occurrence of Major Depressive
      Disorder (MDD). Sleep disturbances, and especially nightmares and insomnia, are quite common
      in patients with PTSD, but the standard treatments for PTSD do not directly focus on sleep
      problems. Perhaps as a result, sleep disturbances are one of the most common residual
      symptoms following both PTSD treatments and depression treatments. Importantly, insomnia,
      depression and PTSD are each characterized by similar biological dysregulation, including
      alterations in important aspects of sleep (rapid eye movement sleep and slow wave sleep) as
      well as processes linked to health and disease (stress system responses and inflammatory
      processes).

      Directly treating sleep in the context of PTSD and MDD is feasible and can lead to robust
      improvements in sleep, though whether improving sleep can enhance PTSD and MDD outcomes
      remains to be established. This study will enroll and randomize 150 participants with PTSD,
      MDD and insomnia. Following baseline assessments (T1) participants will be randomized to
      receive cognitive-behavioral therapy for insomnia(CBTi), a well-supported and highly
      effective insomnia treatment, or to a monitor only control condition. Following this first
      intervention period all participants will receive cognitive processing therapy, a trauma
      focused therapy with known effects on PTSD and depression. The study will test whether and
      how CBTi may(1) achieve improvements in PTSD and MDD symptom severity and (2) lead to
      enhanced response to subsequent treatment with cognitive processing therapy.

      Intervening with CBTi prior to a PTSD-specific treatment and measuring biomarkers
      longitudinally, will allow for the testing of specific effects of sleep improvement on PTSD,
      depressive symptoms, objective aspects sleep and stress and inflammatory markers, thereby
      advancing basic understanding of biobehavioral mechanisms in PTSD and depression.
      Importantly, the proposed approach utilizes a treatment sequence that may appeal to trauma
      survivors with post-traumatic event symptoms who may be resistant to or unprepared to fully
      engage in standard PTSD treatments. Confirmation of the study hypotheses could support
      immediate translation of the findings to clinical practice.
    

Intervention name(s): Cognitive Behavioral Therapy; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive Behavioral Therapy for Insomnia(4 individual therapy sessions over 5 weeks) will consist of a standard, structured, multi-component CBT intervention (sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention) Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions; Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions.
Other intervention name(s): Cognitive-Behavioral Therapy for Insomnia; Cognitive Processing Therapy; Cognitive Processing Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Controlled Trial; Cognitive Therapy; Stress Disorders, Post-Traumatic; Depression; Sleep