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

A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares Compared to Waitlist Control in Active Duty Military Personnel

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.

Study Overview

• Status: Completed
• Conditions: Nightmares
• Intervention / Treatment: Behavioral: ERRT-M for Nightmares

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Hood, Texas, United States, 76544
      • Carl R Darnall Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERRT-M for Nightmares; Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) -	Behavioral: ERRT-M for Nightmares; Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) - Five 60-90 minute sessions administered once weekly. ERRT-M includes psychoeducation, sleep habit modification, relaxation training, written exposure to and rescription of nightmare content and imagery rehearsal of rescripted dream content.; Other Names: Exposure Relaxation & Rescripting
No Intervention: Waitlist control; Participants randomized to the Waitlist control condition will be contacted once weekly for 5 weeks to monitored status and then invited to participant in treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of nightmares reported on the Nightmare Log	Change from baseline to 2-week posttreatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: American Academy of Sleep Medicine

Publications and helpful links

General Publications

• Pruiksma KE, Taylor DJ, Mintz J, Nicholson KL, Rodgers M, Young-McCaughan S, Hall-Clark BN, Fina BA, Dondanville KA, Cobos B, Wardle-Pinkston S, Litz BT, Roache JD, Peterson AL; STRONG STAR Consortium. A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. J Clin Sleep Med. 2020 Jan 15;16(1):29-40. doi: 10.5664/jcsm.8116. Epub 2019 Nov 26.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 119-FP-15; HSC20150396H (Other Identifier: UTHSCSA IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No