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Dismantling Exposure, Relaxation, and Rescripting Therapy (ERRT)

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ClinicalTrials.gov Identifier: NCT02236377
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Joanne Davis, University of Tulsa

Tracking Information
First Submitted Date  ICMJE September 8, 2014
First Posted Date  ICMJE September 10, 2014
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
Nightmare Frequency Past Week [ Time Frame: up to 6 months followup ]
This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02236377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dismantling Exposure, Relaxation, and Rescripting Therapy
Official Title  ICMJE Exposure, Relaxation, Rescripting Therapy (ERRT) Dismantling
Brief Summary

The purpose of this case series dismantling study is to extend previous findings regarding the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose effect and mechanism of change.

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. 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).

Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to conduct a set of case series in order to examine the possible mechanisms: psycho-education, dose response for exposure, and no exposure components of the treatment. Each part of the treatment is theorized to contribute to the improved treatment outcome and it is hypothesized that participants will benefit no matter what group they are in. All participants will receive 5 treatment sessions, conducted twice per week for about 90 minutes, of a modified version of ERRT.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Frequent Trauma-related Nightmares
Intervention  ICMJE Behavioral: Exposure, Relaxation, and Rescripting Therapy
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Name: ERRT
Study Arms  ICMJE
  • Active Comparator: ERRT - Enhanced Exposure
    Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques
    Intervention: Behavioral: Exposure, Relaxation, and Rescripting Therapy
  • Active Comparator: ERRT - Sleep and Relaxation
    Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation
    Intervention: Behavioral: Exposure, Relaxation, and Rescripting Therapy
  • Active Comparator: ERRT-Rescription
    Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure
    Intervention: Behavioral: Exposure, Relaxation, and Rescripting Therapy
  • Active Comparator: ERRT-Sleep
    Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques
    Intervention: Behavioral: Exposure, Relaxation, and Rescripting Therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older at the time of the intake,
  • experienced a traumatic event, as defined by the Diagnostic and Statistical Manua (DSM-5),
  • have approximately one nightmare each week for the past month
  • be able to read and speak English.

Exclusion Criteria:

  • age of 17 or younger
  • acute or apparent psychosis
  • unmedicated bipolar disorder
  • intellectual disability
  • active suicidality,
  • recent parasuicidal behaviors
  • untreated substance use disorder in past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joanne L Davis, PhD 9186312875 joanne-davis@utulsa.edu
Contact: Rachel L Micol, MA 9186313976 rachel-micol@utulsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02236377
Other Study ID Numbers  ICMJE TU1458R1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joanne Davis, University of Tulsa
Study Sponsor  ICMJE University of Tulsa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joanne L Davis, PhD University of Tulsa
PRS Account University of Tulsa
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP