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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 5}

How 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. ^{1 2 3 4 5}

Research Team

Joanne L Davis, PhD

Principal Investigator

University of Tulsa

Eligibility 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)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Exposure, relaxation, and rescripting treatment for trauma-related nighmares. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial to dismantle exposure, relaxation, and rescripting therapy (ERRT) for trauma-related nightmares. [2019]