Integrating Sleep, Nightmare and PTSD Treatments
CPTERRT
Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 8, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 22, 2024
November 1, 2024
10.3 years
September 8, 2014
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nightmare Frequency
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.
up to 6-months follow-up
Secondary Outcomes (1)
Clinician Administered PTSD Scale
Past Month symptoms measured at baseline, and 3 and 6 month follow-up
Study Arms (3)
Cognitive Processing Therapy-Cognitive
ACTIVE COMPARATOR12 sessions of cognitive processing therapy-Cognitive
ERRT + CPT-C
ACTIVE COMPARATOR5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive
CPT-C + ERRT
ACTIVE COMPARATOR12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy
Interventions
5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
Eligibility Criteria
You may qualify if:
- Years of Age minimal
- Experienced a trauma
- One nightmare per week for past month, minimal
- meet full criteria for PTSD
You may not qualify if:
- years of age or younger
- acute psychosis
- bipolar disorder
- intellectual disability
- active suicidality
- untreated substance use disorder within past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tulsa
Tulsa, Oklahoma, 74104, United States
Related Publications (1)
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.
PMID: 22171201BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne l Davis, PhD
University of Tulsa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 8, 2014
First Posted
September 10, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
November 22, 2024
Record last verified: 2024-11