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 to 6 treatment sessions, conducted once per week for about 90 minutes, of a modified version of ERRT.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 years study duration

Study Start

First participant enrolled

August 1, 2014

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed

10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

10.9 years

First QC Date

September 8, 2014

Last Update Submit

July 1, 2024

Conditions

Frequent Trauma-related Nightmares

Keywords

ERRTNightmaresSleepTraumaPTSD

Outcome Measures

Primary Outcomes (1)

Nightmare Frequency Past Week
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