← Back to Search

Cognitive-Behavioral Treatment for PTSD-Related Nightmares in Veterans

N/A

Recruiting

Led By Katherine Elizabeth Miller, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-report global sleep disturbance indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI)

Meet criteria for a current PTSD diagnosis or subthreshold diagnosis

Must not have

Medical conditions that limit ability to apply the treatment e.g., needing a health aide or caregiver to record sleep diaries, unable to get out of bed without assistance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week post-treatment, 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether a cognitive-behavioral treatment can reduce trauma-related nightmares in Veterans. The study uses extended, in-home sleep monitoring to capture sleep data associated with nightmare reports, and assess how these features are altered throughout the treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this behavioral intervention, participants may experience increased distress recalling traumatic events during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

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

Select...

I have had trauma-related nightmares at least once a week for the last month that wake me up.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need help for daily activities and cannot record sleep diaries on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week post-treatment, 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-week post-treatment, 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-treatment, 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Actigraphy-derived respiratory sinus arrhythmia (RSA)

Change in Actigraphy-derived sleep efficiency (SE)

Change in Nightmare Frequency

Secondary study objectives

Change in Nightmare Severity

Change in PTSD Symptom Severity

Other study objectives

Change in Fear of Sleep

Change in Global Sleep Quality

Change in Nightmare Effects

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exposure, Relaxation, and Rescripting Therapy (ERRT)Experimental Treatment1 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 ManagementActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exposure, Relaxation, and Rescripting Therapy

2014

N/A

~90

0 / 5Eligibility criteria met