Integrating Sleep, Nightmare and PTSD Treatments (CPTERRT)
Primary Purpose
Nightmares, PTSD
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure, Relaxation, and Rescripting Therapy
Cognitive Processing Therapy - Cognitive
Sponsored by
About this trial
This is an interventional treatment trial for Nightmares focused on measuring Nightmare, PTSD, Sleep, Emotion Regulation, Exposure Relaxation and Rescripting Therapy, Cognitive Processing Therapy
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
Sites / Locations
- University of TulsaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cognitive Processing Therapy-Cognitive
ERRT + CPT-C
CPT-C + ERRT
Arm Description
12 sessions of cognitive processing therapy-Cognitive
5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive
12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinician Administered PTSD Scale
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02236390
Brief Title
Integrating Sleep, Nightmare and PTSD Treatments
Acronym
CPTERRT
Official Title
Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tulsa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nightmares, PTSD
Keywords
Nightmare, PTSD, Sleep, Emotion Regulation, Exposure Relaxation and Rescripting Therapy, Cognitive Processing Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Processing Therapy-Cognitive
Arm Type
Active Comparator
Arm Description
12 sessions of cognitive processing therapy-Cognitive
Arm Title
ERRT + CPT-C
Arm Type
Active Comparator
Arm Description
5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive
Arm Title
CPT-C + ERRT
Arm Type
Active Comparator
Arm Description
12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy
Intervention Type
Behavioral
Intervention Name(s)
Exposure, Relaxation, and Rescripting Therapy
Other Intervention Name(s)
ERRT, IRT
Intervention Description
5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy - Cognitive
Other Intervention Name(s)
CPT-C, CPT
Intervention Description
12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
Primary Outcome Measure Information:
Title
Nightmare Frequency
Description
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.
Time Frame
up to 6-months follow-up
Secondary Outcome Measure Information:
Title
Clinician Administered PTSD Scale
Description
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)
Time Frame
Past Month symptoms measured at baseline, and 3 and 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne L Davis, PhD
Phone
9186312875
Email
joanne-davis@utulsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia D Villarreal, MS
Phone
9186313976
Email
ldv0460@utulsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne l Davis, PhD
Organizational Affiliation
University of Tulsa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne L Davis, PhD
Phone
918-631-2875
Email
joanne-davis@utulsa.edu
First Name & Middle Initial & Last Name & Degree
Lucia D Villarreal, MS
Phone
9186313976
Email
ldv0460@utulsa.edu
First Name & Middle Initial & Last Name & Degree
Joanne L Davis, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22171201
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.
Results Reference
background
Links:
URL
http://nightmaretreatment.org
Description
Related Info
Learn more about this trial
Integrating Sleep, Nightmare and PTSD Treatments
We'll reach out to this number within 24 hrs