A Trial of Treatment for Trauma-Related Nightmares in Active Duty Military Personnel

Not Applicable

Completed

• Conditions: Nightmares
• Interventions: Behavioral: ERRT-M for Nightmares

• Registration Number: NCT02506595
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

The purpose of this study is to obtain preliminary data of the efficacy of Exposure, Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.

Detailed Description

This will be a pilot randomized controlled trial to compare the effects of Exposure, Relaxation, and Rescripting Therapy for military populations (ERRT-M) among active duty service members. Participants will be randomized to 5 sessions of ERRT-M (n = 20 ) or to a 5-week waitlist control group (WL; n = 20).

Participants will complete all interviews and self-report measures 1 weeks following treatment or the WL condition and 1 month after completing treatment.

Study Timeline

• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Study Start: 2016-02
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Active duty military stationed at Fort Hood as assessed by self-report.
• Able to speak and read English.
• History of a traumatic event.
• Nightmare Disorder
• Stable on psychotropic and/or hypnotic medications and/or interventions for sleep (e.g., Continuous Positive Air Pressure for sleep apnea) administered by other providers for at least one month assessed by self-report and review of medical record.
• Willingness to refrain from beginning new behavioral health or medication treatment for issues pertaining to sleep, PTSD, or nightmares during participation in the study.
• Indication that the SM plans to be in the area for the 5 months following the first assessment

Exclusion Criteria

• Current suicide or homicide risk meriting crisis intervention.
• Severe brain damage, assessed by the inability to comprehend baseline questionnaires.
• Pregnancy at baseline.
• Serious mental health diagnosis such as bipolar disorder or psychosis, assessed with the pre-treatment health interview and review of medical record.
• Currently taking propranolol.
• Currently engaged in evidence-based treatment for PTSD (i.e., Prolonged Exposure Therapy or Cognitive Processing Therapy) or Insomnia (i.e., Cognitive Behavioral Therapy for Insomnia).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ERRT-M for Nightmares	ERRT-M for Nightmares	Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) -

Primary Outcome Measures

Name	Time	Method
Number of nightmares reported on the Nightmare Log	Change from baseline to 2-week posttreatment

Secondary Outcome Measures

Name	Time	Method
Total score on the Insomnia Severity Index (ISI)	Change from baseline to 2-week posttreatment
Total score on the Clinician Administered PTSD Scale (CAPS-5)	Change from baseline to 2-week posttreatment
Total score on the PTSD Checklist -DSM-5 (PCL-5)	Change from baseline to 2-week posttreatment
Total score on the Patient Health Questionnaire (PHQ-9)	Change from baseline to 2-week posttreatment

Trial Locations

Locations (1)

Carl R Darnall Army Medical Center; 🇺🇸 Fort Hood, Texas, United States