- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236377
Dismantling Exposure, Relaxation, and Rescripting Therapy (ERRT)
Exposure, Relaxation, Rescripting Therapy (ERRT) Dismantling
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 to 6 treatment sessions, conducted once per week for about 90 minutes, of a modified version of ERRT.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joanne L Davis, PhD
- Phone Number: 9186312875
- Email: joanne-davis@utulsa.edu
Study Contact Backup
- Name: Lucia D Villarreal, MS
- Phone Number: 9186313976
- Email: LDV0460@utulsa.edu
Study Locations
-
-
Oklahoma
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Tulsa, Oklahoma, United States, 74104
- Recruiting
- Joanne L. Davis
-
Contact:
- Lucia D Villarreal, MS
- Phone Number: 9186313976
- Email: LDV0460@utulsa.edu
-
Contact:
- Joanne L Davis, PhD
- Phone Number: 918-631-2875
- Email: joanne-davis@utulsa.edu
-
Principal Investigator:
- Joanne L Davis, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Manual (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ERRT - Enhanced Exposure
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques
|
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Names:
|
Active Comparator: ERRT - Sleep and Relaxation
Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation
|
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Names:
|
Active Comparator: ERRT-Rescription
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure
|
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Names:
|
Active Comparator: ERRT-Sleep
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques
|
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Names:
|
Active Comparator: ERRT - Consensus Manual
Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.
|
Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 6 months followup
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joanne L Davis, PhD, University of Tulsa
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TU1458R1
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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