Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress
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.
Stress Disorders, Post-Traumatic
Behavioral: Cognitive Behavioral Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of CBT for Insomnia in Patients With PTSD and Depression|
- PTSD (intensity and frequency for each symptom, and remission) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]The Clinician Administered PTSD Scale (CAPS)will be used as our primary PTSD outcome measure.
- Depression [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]The Hamilton Rating Scale for Depression-17 (HRSD-17)will be used as our primary measure of depressive symptoms. The MINI will be used to identify MDD remission status.
- insomnia severity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]The Insomnia Severity Index will measure insomnia severity.
- Sleep [ Time Frame: 7 weeks. ] [ Designated as safety issue: No ]The primary objective sleep outcomes will be rapid eye movement (REM) arousals and Slow Wave Activity.
- Salivary Cortisol [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]Salivary cortisol will be measured in the Psychoneuroimmunology (PNI) Lab using a cortisol HS enzyme immunoassay kit.
- Inflammatory cytokine levels (IL-6) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]Inflammatory cytokine levels (IL-6) will be measured in the PNI Lab using Quantikine high sensitivity (HS) ELISA kits.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Control (brief check-in calls) and Cognitive Processing Therapy (12 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.
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia (4 individual therapy sessions over 5 weeks) and Cognitive Processing Therapy (12 individual weekly sessions)
Behavioral: Cognitive Behavioral Therapy
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743339
|Contact: Wilfred R. Pigeon, Ph.D.||585-275-3374||Wilfred_Pigeon@URMC.Rochester.edu|
|Contact: Kathi L. Heffner, Ph.D.||585-273-4786||kathi_heffner@URMC.rochester.edu|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Wilfred R. Pigeon, Ph.D. 585-273-2900 Wilfred_Pigeon@URMC.Rochester.edu|
|Principal Investigator:||Wilfred R. Pigeon, Ph.D.||University of Rochester|
|Principal Investigator:||Kathi L. Heffner, Ph.D.||University of Rochester|