Exposure, Relaxation, and Rescripting Therapy for Trauma Nightmares

(ERRT Trial)

Overseen By Lucia D Villarreal, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tulsa

Disqualifiers: Psychosis, Bipolar, Suicidality, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 5-6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores Exposure, Relaxation, and Rescripting Therapy (ERRT), which reduces trauma-related nightmares and improves sleep quality. The study aims to understand how different parts of the therapy contribute to its effectiveness by testing various approaches, such as focusing on sleep or enhanced exposure techniques. It targets individuals who have experienced a traumatic event and have nightmares about once a week. Participants will attend 5 to 6 therapy sessions, each lasting about 90 minutes, to evaluate the effectiveness of different therapy techniques. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance therapeutic approaches for trauma-related nightmares.

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 prior data suggests that Exposure, Relaxation, and Rescripting Therapy is safe for treating trauma-related nightmares?

Research shows that Exposure, Relaxation, and Rescripting Therapy (ERRT) is generally safe for individuals with trauma-related nightmares. Studies have found that ERRT reduces the frequency and intensity of these nightmares, improves overall sleep quality, and lessens symptoms of PTSD and depression. Importantly, these studies reported no serious side effects, indicating that the therapy is well-tolerated.

Participants in these studies often experienced lower heart rates during nightmare imagery, suggesting a calming effect from the therapy. In one study, 15.2% of veterans reported no longer having nightmares, and many others experienced improved sleep after completing ERRT. While researchers continue to explore the therapy's mechanisms, the evidence supports its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exposure, Relaxation, and Rescripting Therapy (ERRT) for trauma nightmares because it offers a fresh take on handling distressing dreams. Unlike traditional therapies such as medication or cognitive-behavioral therapy that generally focus on symptom management, ERRT directly addresses the nightmare content and emotional responses. The therapy's unique approach includes specific techniques like "rescripting," where the nightmare is transformed into a less distressing story, and enhanced sleep strategies to improve overall sleep quality. By combining these elements, ERRT aims to provide more comprehensive and lasting relief for individuals suffering from trauma-induced nightmares.

What evidence suggests that this trial's treatments could be effective for trauma-related nightmares?

Research shows that Exposure, Relaxation, and Rescripting Therapy (ERRT) effectively treats trauma-related nightmares. Studies have found that ERRT significantly reduces the frequency and intensity of these nightmares. It also improves overall sleep quality for both civilians and veterans. Participants in this trial will be assigned to different ERRT-based treatment arms, such as ERRT-Sleep, ERRT-Enhanced Exposure, or ERRT-Rescription, each focusing on specific techniques. After ERRT, participants often experience a decrease in symptoms of PTSD (post-traumatic stress disorder) and depression. The treatment includes learning, relaxation exercises, and altering the narrative of nightmares to address sleep problems. This method is well-supported as a recommended treatment, highlighting its potential benefits. ^{2 4 6 7 8}

Who Is on the Research Team?

Joanne L Davis, PhD

Principal Investigator

University of Tulsa

Are You a Good Fit for This Trial?

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.

Experienced a traumatic event, as defined by the Diagnostic and Statistical Manual (DSM-5)

Exclusion Criteria

Untreated substance use disorder in past 6 months

Recent parasuicidal behaviors

I have bipolar disorder and am not taking medication for it.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exposure, Relaxation, and Rescripting Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: ERRT-Sleep Active Control 1 Intervention

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

Group II: ERRT - Enhanced Exposure Active Control 1 Intervention

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

Group III: ERRT-Rescription Active Control 1 Intervention

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

Group IV: ERRT - Consensus Manual Active Control 1 Intervention

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

Group V: ERRT - Sleep and Relaxation Active Control 1 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

Who Is Running the Clinical Trial?

University of Tulsa

Lead Sponsor

Trials

16

Recruited

5,100+

Published Research Related to This Trial

The Exposure, Relaxation, and Rescripting Therapy for Military service members and veterans (ERRT-M) showed medium-sized reductions in nightmare frequency and severity, as well as improvements in PTSD, depression, and insomnia symptoms among 38 participants after treatment.

Participants rated ERRT-M as credible and acceptable, with a dropout rate of 17.5%, similar to other treatments, suggesting it could be a promising option for addressing trauma-related nightmares in active duty military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. Pruiksma, KE., Taylor, DJ., Mintz, J., et al.[2023]

A study involving 70 participants found that both exposure, relaxation, and rescripting therapy (ERRT) with and without nightmare exposure significantly reduced nightmares and related distress, showing medium to large effect sizes.

The addition of nightmare exposure and rescripting did not lead to better outcomes compared to the standard ERRT, suggesting that the core components of the therapy may be sufficient for alleviating nightmares and associated symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial to dismantle exposure, relaxation, and rescripting therapy (ERRT) for trauma-related nightmares. Pruiksma, KE., Cranston, CC., Rhudy, JL., et al.[2019]

Trauma victims often experience sleep disturbances, particularly nightmares, which are linked to their overall distress levels, highlighting the need for effective treatments.

Imagery Rehearsal Therapy (IRT) is the most supported treatment for trauma-related nightmares, and a modified version of IRT is being tested in a randomized clinical trial, incorporating enhanced exposure and trauma themes to improve efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure, relaxation, and rescripting treatment for trauma-related nighmares. Davis, JL., Wright, DC.[2019]

In a randomized controlled trial with 104 patients suffering from nightmare disorder, both imagery rescripting (IR) and imaginal exposure (IE) significantly reduced nightmare frequency and distress compared to a wait-list control group.

The positive effects of both treatments were not only immediate but also sustained over 3- and 6-month follow-ups, suggesting that IR and IE are effective components of cognitive-behavioral therapies for nightmares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. Kunze, AE., Arntz, A., Morina, N., et al.[2019]

A modified treatment called Exposure, Relaxation, and Rescripting Therapy, which builds on imagery rehearsal techniques, showed promise in reducing the frequency and severity of nightmares in a case series of 4 participants (1 male and 3 females).

Three out of the four participants also experienced reductions in posttraumatic stress and depression symptoms, along with improvements in sleep quality and quantity, suggesting that this approach may be beneficial for individuals with trauma-related nightmares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case series utilizing exposure, relaxation, and rescripting therapy: impact on nightmares, sleep quality, and psychological distress. Davis, JL., Wright, DC.[2019]

Citations

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This study details results of an open trial of a group psychological treatment for Veterans with posttraumatic stress disorder (PTSD) and chronic posttraumatic ...

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Treatment-related decreases in heart rate to nightmare imagery were correlated with improve- ments in sleep quality and quantity; treatment-related decreas- es ...

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Randomized controlled trial to dismantle exposure, relaxation, and rescripting therapy (ERRT) for trauma-related nightmares. Psychological ...