Cognitive-Behavioral Treatment for PTSD-Related Nightmares in Veterans

Recruiting at 1 trial location

Overseen By Katherine Elizabeth Miller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use disorders, Bipolar, Psychotic, others

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

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Trauma-related nightmares in Veterans are associated with poor clinical outcomes, greater substance use, and increased risk of suicide. In spite of an urgent need to reduce the burden of trauma-related nightmares, the underlying physiological changes associated with them are poorly understood, and there are no clear evidence-based recommendations for their treatment. Limitations of current assessment procedures represent a barrier to improved care. In-laboratory sleep studies rarely capture nightmares, limiting the knowledge about them and their response to treatment. This study addresses these limitations by using extended, in-home sleep monitoring to capture sleep data associated with nightmare reports in Veterans, and assessing how these features are altered throughout a cognitive-behavioral nightmare treatment. Results from this study will increase understanding of trauma-related nightmares, and advance strategies for personalizing symptom management for Veterans.

Will I have to stop taking my current medications?

The trial requires that you be stable on any psychoactive medications for at least two weeks before starting. This means you can continue your current medications as long as they have been stable for that period.

Is cognitive-behavioral treatment for PTSD-related nightmares in veterans safe?

The studies on Exposure, Relaxation, and Rescripting Therapy (ERRT) for trauma-related nightmares in veterans and military personnel suggest that it is generally safe. Participants reported improvements in sleep quality and a reduction in nightmares, with no significant safety concerns mentioned. ^{1 2 3 4 5}

How is the treatment ERRT different from other treatments for PTSD-related nightmares in veterans?

ERRT (Exposure, Relaxation, and Rescripting Therapy) is unique because it combines exposure techniques with relaxation and rescripting strategies to directly target and reduce the frequency and severity of nightmares, improve sleep quality, and alleviate PTSD symptoms in veterans. This approach is specifically adapted for military populations and focuses on modifying the content of nightmares, which is different from other treatments that may not directly address the nightmares themselves. ^{2 4 5 6 7}

What data supports the effectiveness of the treatment Exposure, Relaxation, and Rescripting Therapy (ERRT) for PTSD-related nightmares in Veterans?

Research shows that ERRT, adapted for military use, has been effective in reducing nightmare frequency and severity, improving sleep quality, and decreasing symptoms of PTSD and depression in Veterans. In a pilot study, 50% of participants reported no nightmares a week after treatment, and these improvements were maintained at a 2-month follow-up. ^{1 2 4 5 7}

Who Is on the Research Team?

Katherine Elizabeth Miller, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD or subthreshold PTSD, experiencing frequent trauma-related nightmares, and enrolled in VA care at the Minneapolis VA Health Care System. They must have stable housing, be on steady psychoactive meds for two weeks prior to the study, and not be involved in other PTSD-focused treatments.

Inclusion Criteria

I have trouble sleeping, as shown by my PSQI score of 5 or more.

I have been diagnosed with PTSD or have symptoms close to it.

I have been diagnosed with PTSD or have symptoms close to PTSD.

Exclusion Criteria

Current pregnancy and/or birth of a child within the previous 6 months

You were in the hospital for a mental health issue in the last 2 months.

You are currently thinking about harming yourself or others.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Sleep Monitoring

Participants monitor their sleep for a week using a multi-night mattress actigraphy and one-night polysomnography to calibrate sleep efficiency and identify untreated sleep apnea.

1 week

In-home monitoring

Treatment

Participants undergo five weeks of either Exposure, Relaxation, and Rescripting Therapy (ERRT) or Sleep and Nightmare Management, with continuous sleep monitoring.

5 weeks

5 visits (in-person, weekly)

Post-treatment Assessment

Assessment of subjective symptom change and physiological parameters post-treatment.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in sleep and nightmare-related symptoms at 1-week and 3-month post-treatment.

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exposure, Relaxation, and Rescripting Therapy
• Sleep and Nightmare Management

Trial Overview The study tests a cognitive-behavioral therapy called Exposure, Relaxation, and Rescripting Therapy (ERRT) aimed at managing sleep disturbances and nightmares. It involves extended in-home sleep monitoring to understand physiological changes during trauma-related nightmares.

How Is the Trial Designed?

Group I: Exposure, Relaxation, and Rescripting Therapy (ERRT) Experimental Treatment 1 Intervention

Exposure, Relaxation, \& Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately one hour per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, sleep behavior modification, Progressive Muscle Relaxation, diaphragmatic breathing, exposure to the trauma-nightmare, rescription, and treatment maintenance planning.

Group II: Sleep and Nightmare Management Active Control 1 Intervention

This treatment protocol has amounts of therapist contact, handouts, and homework between sessions equivalent to those in ERRT. The protocol contains psychoeducation about sleep disturbances and trauma-related nightmares, including their distressing nature, chronicity, and impact on sleep and daytime functioning. Additionally, basic sleep behavior modification are presented. No nightmare content or rescripting will be explicitly discussed, and the diaphragmatic breathing techniques will be omitted from this protocol.

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?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A pilot study involving 19 trauma-exposed Veterans showed that the adapted treatment protocol, Exposure, Relaxation, and Rescription Therapy for Military (ERRT-M), significantly improved sleep quality, reduced nightmare frequency and severity, and alleviated symptoms of depression and insomnia after just one week of treatment.

At a 2-month follow-up, half of the participants reported being free of nightmares, indicating that ERRT-M can effectively address sleep disturbances and related mental health issues in Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a brief treatment for nightmares and sleep disturbances for veterans. Balliett, NE., Davis, JL., Miller, KE.[2016]

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 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]

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 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]

Citations

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

Efficacy of a brief treatment for nightmares and sleep disturbances for veterans. [2016]

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Imagery rescripting and exposure group treatment of posttraumatic nightmares in Veterans with PTSD. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Imagery rehearsal therapy for posttraumatic nightmares in U.S. veterans. [2019]