Managing Sleep Symptoms and Modifying Mechanisms of Traumatic Stress

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wilfred Pigeon, PhD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01743339
First received: December 4, 2012
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Stress Disorders, Post-Traumatic
Depression
Sleep
Behavioral: Cognitive Behavioral Therapy
Behavioral: Control

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • insomnia severity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    The Insomnia Severity Index will measure insomnia severity.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control (brief check-in calls) and Cognitive Processing Therapy (12 individual weekly sessions)
Behavioral: Control
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 Names:
  • Control
  • Cognitive Processing Therapy
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
Other Names:
  • Cognitive-Behavioral Therapy for Insomnia
  • Cognitive Processing Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be English-speaking
  • age 18-64 years old
  • with exposure to trauma from interpersonal violence in the past year
  • meet diagnostic criteria for full or subthreshold PTSD
  • meet diagnostic criteria for MDD
  • meet criteria for Insomnia Disorder

Exclusion Criteria:

  • untreated sleep disorders other than insomnia or nightmares
  • dementia or cognitive impairment
  • history of schizophrenia or bipolar I disorder
  • current suicidality
  • health conditions with immunological components or taking immunosuppressive therapies
  • active alcohol dependence
  • medication use including antipsychotics, opiate analgesics, and sleep medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743339

Contacts
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

Locations
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   
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Wilfred R. Pigeon, Ph.D. University of Rochester
Principal Investigator: Kathi L. Heffner, Ph.D. University of Rochester
  More Information

No publications provided

Responsible Party: Wilfred Pigeon, PhD, Associate Professor of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT01743339     History of Changes
Other Study ID Numbers: 44033, R01NR013909
Study First Received: December 4, 2012
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Randomized Controlled Trial
Cognitive Therapy
Stress Disorders, Post-Traumatic
Depression
Sleep

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on October 19, 2014