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Completed

NCT Number: NCT02236390

Integrating Sleep, Nightmare and PTSD Treatments

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tulsa

Tulsa, Oklahoma, 74104, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exposure, Relaxation, and Rescripting Therapy

Behavioral

5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms

Other names: ERRT, IRT

Cognitive Processing Therapy - Cognitive

Behavioral

12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.

Other names: CPT-C, CPT

Primary outcomes

  1. 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

  1. Clinician Administered PTSD Scale

    Time frame: Past Month symptoms measured at baseline, and 3 and 6 month follow-up

    This semi-structured clinical interview assesses severity of each of 30 items measuring Diagnostic and Statistical Manual (DSM-5) criteria for PTSD on a 5-point scale (0 - 4), (possible range: 0-80). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four factors (reexperiencing, avoidance, cognitive/emotional and hyperarousal)

Sponsors and collaborators

Lead sponsor

University of Tulsa

Other

Registry information

Official study title

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

Acronym: CPTERRT

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2014
Registry last updated
Nov 22, 2024

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

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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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