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Completed

NCT Number: NCT02506595

A Trial of Treatment for Trauma-Related Nightmares 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ERRT-M for Nightmares

Behavioral

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

Primary outcomes

  1. Number of nightmares reported on the Nightmare Log

    Time frame: Change from baseline to 2-week posttreatment

Secondary outcomes

  1. Total score on the Insomnia Severity Index (ISI)

    Time frame: Change from baseline to 2-week posttreatment

  2. Total score on the Clinician Administered PTSD Scale (CAPS-5)

    Time frame: Change from baseline to 2-week posttreatment

  3. Total score on the PTSD Checklist -DSM-5 (PCL-5)

    Time frame: Change from baseline to 2-week posttreatment

  4. Total score on the Patient Health Questionnaire (PHQ-9)

    Time frame: Change from baseline to 2-week posttreatment

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2015
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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