Dismantling Exposure, Relaxation, and Rescripting Therapy

NCT ID: NCT02236377

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Frequent Trauma-related Nightmares

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ERRT - Enhanced Exposure

Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems

ERRT - Sleep and Relaxation

Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems

ERRT-Rescription

Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems

ERRT-Sleep

Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems

ERRT - Consensus Manual

Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems

Interventions

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Exposure, Relaxation, and Rescripting Therapy

Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems

Intervention Type BEHAVIORAL

Other Intervention Names

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ERRT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tulsa

OTHER

Sponsor Role lead

Responsible Party

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Joanne Davis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanne L Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tulsa

Locations

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Joanne L. Davis

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joanne L Davis, PhD

Role: CONTACT

9186312875

Lucia D Villarreal, MS

Role: CONTACT

9186313976

Facility Contacts

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Joanne L Davis, PhD

Role: primary

918-631-2875

Lucia D Villarreal, MS

Role: backup

9186313976

References

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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.

Reference Type BACKGROUND
PMID: 22171201 (View on PubMed)

Other Identifiers

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TU1458R1

Identifier Type: -

Identifier Source: org_study_id

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