Clinical trial NCT02236390: Integrating Sleep, Nightmare and PTSD Treatments
Official title: Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmares
PTSD
Keywords: Nightmare
PTSD
Sleep
Emotion Regulation
Exposure Relaxation and Rescripting Therapy
Cognitive Processing Therapy
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Nightmare Frequency
timeFrame: up to 6-months follow-up
Secondary outcomes:
measure: Clinician Administered PTSD Scale
timeFrame: Past Month symptoms measured at baseline, and 3 and 6 month follow-up
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Tulsa
state: Oklahoma
Study officials:
affiliation: University of Tulsa
name: Joanne l Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466.