Cognitive-Behavioral Treatment for PTSD-Related Nightmares in Veterans

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans experiencing PTSD-related nightmares, which worsen mental health and increase risks such as substance use and suicide. Researchers are testing two treatments: one involves therapy sessions that focus on relaxation and changing nightmare content (Exposure, Relaxation, and Rescripting Therapy), while the other focuses on managing sleep and nightmares without altering the nightmare content. Veterans who have experienced trauma, have PTSD, and suffer from nightmares at least once a week might be suitable candidates. The study employs home sleep monitoring to better understand how these treatments affect nightmares and sleep. As an unphased trial, this study offers Veterans the chance to contribute to important research that could enhance PTSD treatment options.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that therapies like Exposure, Relaxation, and Rescripting Therapy (ERRT) are well-received by individuals who have experienced trauma and suffer from nightmares. One study found that ERRT is not only effective but also considered trustworthy and acceptable by participants. Most people find the therapy manageable and feel comfortable with the treatment.

Additionally, research on similar methods, such as imagery rescripting, has shown they can improve sleep without causing major side effects, boosting confidence in the safety of these therapies.

In contrast, the Sleep and Nightmare Management treatment focuses on educating participants about sleep problems and encouraging small behavioral changes. This therapy is typically low risk and safe, as it primarily involves discussion and minor adjustments to sleep habits.

Overall, these findings suggest that both treatments are generally safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD-related nightmares in veterans because they offer unique approaches compared to standard therapies like medication or traditional talk therapy. Exposure, Relaxation, and Rescripting Therapy (ERRT) combines techniques such as progressive muscle relaxation and trauma-nightmare exposure, coupled with rescripting the nightmare, which aims to alter the content of distressing dreams. This holistic approach not only addresses the nightmares directly but also promotes overall sleep health. On the other hand, Sleep and Nightmare Management provides psychoeducation about sleep and nightmares without delving into the specific content of nightmares, focusing instead on general sleep improvements and behavioral changes. Both methods prioritize practical skills and coping strategies, potentially offering more immediate and tangible benefits for veterans struggling with these issues.

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

This trial will compare two treatments for PTSD-related nightmares in Veterans: Exposure, Relaxation, and Rescripting Therapy (ERRT) and Sleep and Nightmare Management. Studies have shown that ERRT can significantly reduce the frequency and severity of nightmares in individuals with PTSD. Research indicates that ERRT not only alleviates nightmares but also improves PTSD symptoms, depression, and sleep quality. Specifically, a study with Veterans found that attending ERRT sessions led to significant improvements in both nightmares and PTSD symptoms.

In contrast, Sleep and Nightmare Management addresses sleep problems, which can lessen the severity of nightmares and enhance the effectiveness of other PTSD treatments. Managing sleep issues is crucial because nightmares are common among Veterans with PTSD and can affect their overall mental and physical health. ^{1 2 3 4 6}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7053000/

A pilot randomized controlled trial of cognitive behavioral ... Conclusions: ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia. Participants ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088761851100003X

Imagery rescripting and exposure group treatment of ... ▻ 37 Veterans with PTSD and trauma-related nightmares attended a 6-session group. ▻ Treatment significantly reduced nightmares, PTSD severity, and sleep ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3227708/

Physiological Predictors of Response to Exposure ... The first RCT demonstrated that ERRT reduced nightmare frequency and severity, related psychopathology, and improved sleep in trauma-exposed adults. While the ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cpp.3025

The Effectiveness of Imagery Rescripting Interventions for ... Significant improvements in nightmare frequency, sleep quality and PTSD symptoms were also found in imagery rescripting interventions from ...

5. research.va.gov research.va.gov/currents/0319-PTSD-nightmares.cfm

PTSD nightmares: Is there an effective treatment? Research results on therapies for PTSD patients who are experiencing nightmares have been inconsistent.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02242110?term=AREA%5BBasicSearch%5D(Bipolar%20Disorder)&rank=1

NCT02242110 | Brief Treatment for Trauma Nightmares in ... This pilot study will examine the efficacy of Exposure, Relaxation, & Rescripting Therapy (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with ...