Exposure, Relaxation, and Rescripting Therapy for Trauma Nightmares
(ERRT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Tulsa
Disqualifiers: Psychosis, Bipolar, Suicidality, Substance use, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Exposure, Relaxation, and Rescripting Therapy (ERRT) for trauma nightmares?
Research shows that ERRT, which includes techniques like imagery rehearsal and exposure, can reduce the frequency and severity of nightmares, improve sleep quality, and decrease symptoms of posttraumatic stress and depression. Studies have found that similar therapies, such as imagery rescripting and imaginal exposure, are effective in reducing nightmare symptoms and distress.
12345Is Exposure, Relaxation, and Rescripting Therapy (ERRT) safe for humans?
Research on Exposure, Relaxation, and Rescripting Therapy (ERRT) for trauma-related nightmares suggests it is generally safe, as studies report improvements in nightmare frequency and psychological distress without mentioning significant adverse effects.
12345How is Exposure, Relaxation, and Rescripting Therapy (ERRT) different from other treatments for trauma-related nightmares?
ERRT is unique because it combines exposure to nightmare content, relaxation techniques, and rescripting (changing the storyline) of the nightmare, with an enhanced focus on exposure and incorporating trauma themes, which is different from other therapies that may not emphasize all these components together.
12345Eligibility Criteria
This trial is for adults who have experienced a traumatic event and suffer from frequent trauma-related nightmares, at least once weekly over the past month. Participants must be able to read and speak English. It's not suitable for individuals under 18, those with active suicidal thoughts, unmedicated bipolar disorder, recent substance abuse issues, psychosis, recent self-harm behaviors or intellectual disabilities.Inclusion Criteria
I have had about one nightmare every week for the last month.
I am 18 years old or older.
Experienced a traumatic event, as defined by the Diagnostic and Statistical Manual (DSM-5)
+1 more
Exclusion Criteria
Untreated substance use disorder in past 6 months
Recent parasuicidal behaviors
I have bipolar disorder and am not taking medication for it.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 5 to 6 weekly sessions of Exposure, Relaxation, and Rescripting Therapy (ERRT) for chronic post-trauma nightmares
5-6 weeks
5-6 visits (in-person)
Follow-up
Participants are monitored for changes in nightmare frequency and other symptoms after treatment
up to 6 months
Participant Groups
The study tests Exposure, Relaxation, and Rescripting Therapy (ERRT), a psychological treatment aimed at reducing the frequency and severity of post-trauma nightmares and improving sleep quality. The trial seeks to understand how different components of ERRT contribute to its effectiveness through weekly sessions lasting about 90 minutes each.
5Treatment groups
Active Control
Group I: ERRT-SleepActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques
Group II: ERRT - Enhanced ExposureActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques
Group III: ERRT-RescriptionActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure
Group IV: ERRT - Consensus ManualActive Control1 Intervention
Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.
Group V: ERRT - Sleep and RelaxationActive Control1 Intervention
Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation
Exposure, Relaxation, and Rescripting Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as ERRT for:
- Trauma-related nightmares
- Sleep disturbances
- PTSD symptoms
- Depression symptoms
🇪🇺 Approved in European Union as ERRT for:
- Trauma-related nightmares
- Sleep disturbances
- PTSD symptoms
- Depression symptoms
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Joanne L. DavisTulsa, OK
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Who Is Running the Clinical Trial?
University of TulsaLead Sponsor
References
A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. [2023]The aim of this study was to obtain preliminary data on the efficacy, credibility, and acceptability of Exposure, relaxation, and rescripting therapy for military service members and veterans (ERRT-M) in active duty military personnel with trauma-related nightmares.
Exposure, relaxation, and rescripting treatment for trauma-related nighmares. [2019]Trauma victims frequently report sleep disturbances, including nightmares, following traumatic events. Research indicates that nightmares are associated with the level and severity of other indices of distress. The recognition of the prominence of trauma-related nightmares, in prevalence and impact, has in part heightened efforts to develop and assess techniques to alleviate these difficulties. The majority of such previous efforts were predominantly case studies or uncontrolled group studies; however, recently several controlled studies have been conducted. The treatment with the most empirical support is generally called imagery rehearsal therapy (IRT). This treatment commonly involves relaxation procedures, limited exposure to the nightmare content, rewriting the content of the nightmare, and rehearsal of the altered content. This article provides a description of a modified version of IRT that incorporates all these techniques, with an enhanced exposure component and the addition of trauma themes and alteration of sleep habits. Guidelines for application with clients are outlined. A case study and case series were completed on this variant of IRT and a randomized clinical trial is currently underway.
Case series utilizing exposure, relaxation, and rescripting therapy: impact on nightmares, sleep quality, and psychological distress. [2019]Experiencing a traumatic event may initiate or exacerbate the occurrence of nightmares. Nightmares may impact sleep quality and quantity, posttraumatic stress symptoms, and depression. Recently, imagery rehearsal has gained attention in the treatment of trauma-related nightmares and is reported to be promising in the reduction of nightmares. On the basis of the vast literature describing the therapeutic benefits of exposure techniques for anxiety-related problems, the treatment was modified to enhance the exposure component. This article presents a case series using this modified version of imagery rehearsal, Exposure, Relaxation, and Rescripting Therapy, with 1 male and 3 female participants. Overall, the participants treated reported a reduction in nightmare frequency and severity; 3 out of 4 participants also reported a reduction in posttraumatic stress and depression symptomotology and an increase in sleep quality and quantity. Clinical implications and future research directions are discussed.
Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. [2019]Nightmares can be effectively treated with cognitive-behavioral therapies. Though it remains elusive which therapeutic elements are responsible for the beneficial effects on nightmare symptoms, imagery rescripting (IR) and imaginal exposure (IE) are commonly identified as active treatment components of nightmare therapies. With this randomized controlled trial, we compared IR and IE as individual treatments to a wait-list (WL) condition to determine whether these particular therapeutic elements ameliorate nightmare symptoms. For this purpose, 104 patients with a primary DSM-5 diagnosis of nightmare disorder were randomly assigned to three weekly individual sessions of either IR or IE, or WL. Results showed that compared to WL, both interventions effectively reduced nightmare frequency (ΔdIR-WL = 0.74; ΔdIE-WL = 0.70) and distress (ΔdIR-WL = 0.98; ΔdIE-WL = 1.35) in a sample that predominantly consisted of idiopathic nightmare sufferers. The effects of IR and IE were comparable to those observed for other psychological nightmare treatments. Initial effects at post-treatment were sustained at 3- and 6-months follow-up, indicating that IR and IE both seem to be efficacious treatment components of nightmare therapies. Additional research is needed to directly compare IR and IE among both idiographic and posttraumatic nightmare sufferers with respect to treatment expectancy, acceptability, and effectiveness.
Randomized controlled trial to dismantle exposure, relaxation, and rescripting therapy (ERRT) for trauma-related nightmares. [2019]The aim of this study was to conduct a preliminary dismantling study of exposure, relaxation, and rescripting therapy (ERRT) for nightmares.