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Clinical Trials/NCT02236390
NCT02236390
Completed
Not Applicable

Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation

University of Tulsa1 site in 1 country90 target enrollmentAugust 2014
ConditionsNightmaresPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nightmares
Sponsor
University of Tulsa
Enrollment
90
Locations
1
Primary Endpoint
Nightmare Frequency
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of the proposed pilot study is to extend previous findings regarding the efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established and efficacious evidence-based psychological treatment for PTSD in both civilian and veteran populations (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver, Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without the utilization of written exposure (CPT-C) may be more effective than the original protocol. However, despite such promising evidence, individuals who experience chronic nightmares and sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment (Nappi, Drummond, & Hall, 2012). Given that nightmares are considered the hallmark of PTSD (Ross, Ball, Sullivan, & Caroff, 1989) and their treatment-resistant nature (Davis & Wright, 2007), specific psychological treatments have been developed to target sleep disturbances and nightmares.

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, & Favorite, 2011).

There is a call to research suggesting the importance of treatment studies which focus on interventions that integrate nightmare and sleep symptom treatment with evidence-based treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances. Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, & Mayeda, 2005; Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may have additional personal coping resources for which s/he can use to address the broader trauma issues (Nappi et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT alone.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
November 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Tulsa
Responsible Party
Principal Investigator
Principal Investigator

Joanne Davis

Professor

University of Tulsa

Eligibility Criteria

Inclusion Criteria

  • 18 Years of Age minimal
  • Experienced a trauma
  • One nightmare per week for past month, minimal
  • meet full criteria for PTSD

Exclusion Criteria

  • 17 years of age or younger
  • acute psychosis
  • bipolar disorder
  • intellectual disability
  • active suicidality
  • untreated substance use disorder within past 6 months

Outcomes

Primary Outcomes

Nightmare Frequency

Time Frame: up to 6-months follow-up

A fill-in-the blank question (range = 0-X nightmares) from the Trauma Related Nightmare Survey will be utilized to determine the past week nightmare frequency at baseline, and 3 and 6 months follow-up. Higher values indicate more nightmares.

Secondary Outcomes

  • Clinician Administered PTSD Scale(Past Month symptoms measured at baseline, and 3 and 6 month follow-up)

Study Sites (1)

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