Integrating Sleep, Nightmare and PTSD Treatments (CPTERRT)

November 20, 2024 updated by: Joanne Davis, University of Tulsa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • University of Tulsa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Processing Therapy-Cognitive
12 sessions of cognitive processing therapy-Cognitive
Behavioral: Cognitive Processing Therapy - Cognitive
12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
Other Names:
  • CPT
  • CPT-C
Active Comparator: ERRT + CPT-C
5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive
Behavioral: Cognitive Processing Therapy - Cognitive
12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
Other Names:
  • CPT
  • CPT-C
Behavioral: Exposure, Relaxation, and Rescripting Therapy
5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
Other Names:
  • ERRT
  • IRT
Active Comparator: CPT-C + ERRT
12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy
Behavioral: Cognitive Processing Therapy - Cognitive
12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
Other Names:
  • CPT
  • CPT-C
Behavioral: Exposure, Relaxation, and Rescripting Therapy
5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
Other Names:
  • ERRT
  • IRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Past Month symptoms measured at baseline, and 3 and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tulsa

Investigators

  • Principal Investigator: Joanne l Davis, PhD, University of Tulsa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimated)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU1459R1
  • HR14-127 (Other Grant/Funding Number: OCAST)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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