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

The University of Texas Health Science Center at San Antonio1 site in 1 country47 target enrollmentFebruary 2016

ConditionsNightmares

Overview

Phase: N/A
Intervention: Not specified
Conditions: Nightmares
Sponsor: The University of Texas Health Science Center at San Antonio
Enrollment: 47
Locations: 1
Primary Endpoint: Number of nightmares reported on the Nightmare Log
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

June 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center at San Antonio

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Number of nightmares reported on the Nightmare Log

Time Frame: Change from baseline to 2-week posttreatment

Secondary Outcomes

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)