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Completed

NCT Number: NCT01743339

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Control

Behavioral

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 Processing Therapy

Primary outcomes

  1. PTSD (intensity and frequency for each symptom, and remission)

    Time frame: 20 weeks

    The Clinician Administered PTSD Scale (CAPS)will be used as our primary PTSD outcome measure.

Secondary outcomes

  1. Insomnia severity

    Time frame: 20 weeks

    The Insomnia Severity Index will measure insomnia severity.

  2. Depression

    Time frame: 20 weeks

    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.

Other outcomes

  1. Sleep

    Time frame: 7 weeks.

    The primary objective sleep outcomes will be rapid eye movement (REM) arousals and Slow Wave Activity.

  2. Salivary Cortisol

    Time frame: 7 weeks

    Salivary cortisol will be measured in the Psychoneuroimmunology (PNI) Lab using a cortisol HS enzyme immunoassay kit.

  3. Inflammatory cytokine levels (IL-6)

    Time frame: 7 weeks

    Inflammatory cytokine levels (IL-6) will be measured in the PNI Lab using Quantikine high sensitivity (HS) ELISA kits.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

A Randomized Controlled Trial of CBT for Insomnia in Patients With PTSD and Depression

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2012
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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