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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Actigraphy-derived respiratory sinus arrhythmia (RSA)

Change in Actigraphy-derived sleep efficiency (SE)

Change in Nightmare Frequency

Secondary outcome measures

Change in Nightmare Severity

Change in PTSD Symptom Severity

Other outcome measures

Change in Fear of Sleep

Change in Global Sleep Quality

Change in Nightmare Effects

+3 more

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,204 Total Patients Enrolled

1 Trials studying Nightmares

108 Patients Enrolled for Nightmares

Katherine Elizabeth Miller, PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN

Media Library

Exposure, Relaxation, and Rescripting Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03974503 — N/A

Nightmares Research Study Groups: Exposure, Relaxation, and Rescripting Therapy (ERRT), Sleep and Nightmare Management

Nightmares Clinical Trial 2023: Exposure, Relaxation, and Rescripting Therapy Highlights & Side Effects. Trial Name: NCT03974503 — N/A

Exposure, Relaxation, and Rescripting Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03974503 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there presently an opportunity to join this experiment?

"According to the information published on clinicaltrials.gov, this investigation is actively enrolling participants. Prospective patients can refer to the original posting date of December 2nd 2019 and its most recent update which occurred in February 9th 2022."

Answered by AI

How many candidates are being considered for inclusion in this experiment?

"Affirmative. Clinicaltrials.gov records indicate that this medical trial is presently seeking volunteers, with the initial posting of December 2nd 2019 and the latest update occurring on February 9th 2022. A total of 96 personnel are needed to be recruited from 1 research site."

Answered by AI