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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

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.


Condition or disease Intervention/treatment Phase
Frequent Trauma-related Nightmares Behavioral: Exposure, Relaxation, and Rescripting Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exposure, Relaxation, Rescripting Therapy (ERRT) Dismantling
Study Start Date : August 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Active Comparator: ERRT - Enhanced Exposure
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques
Behavioral: Exposure, Relaxation, and Rescripting Therapy
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Name: ERRT

Active Comparator: ERRT - Sleep and Relaxation
Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation
Behavioral: Exposure, Relaxation, and Rescripting Therapy
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Name: ERRT

Active Comparator: ERRT-Rescription
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure
Behavioral: Exposure, Relaxation, and Rescripting Therapy
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Name: ERRT

Active Comparator: ERRT-Sleep
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques
Behavioral: Exposure, Relaxation, and Rescripting Therapy
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Name: ERRT




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236377


Contacts
Contact: Joanne L Davis, PhD 9186312875 joanne-davis@utulsa.edu
Contact: Rachel L Micol, MA 9186313976 rachel-micol@utulsa.edu

Locations
United States, Oklahoma
Joanne L. Davis Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Joanne L Davis, PhD    918-631-2875    joanne-davis@utulsa.edu   
Contact: Jenny Y Lee    9186313976    jyl266@utulsa.edu   
Principal Investigator: Joanne L Davis, PhD         
Sponsors and Collaborators
University of Tulsa
Investigators
Principal Investigator: Joanne L Davis, PhD University of Tulsa

Publications:
Responsible Party: Joanne Davis, Associate Professor, University of Tulsa
ClinicalTrials.gov Identifier: NCT02236377     History of Changes
Other Study ID Numbers: TU1458R1
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Joanne Davis, University of Tulsa:
ERRT
Nightmares
Sleep
Trauma
PTSD