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

Nightmares Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506595
• Other study ID #: 119-FP-15
• Secondary ID: HSC20150396H
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Nightmares

Intervention

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.

Locations

Country	Name	City	State
United States	Carl R Darnall Army Medical Center	Fort Hood	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of nightmares reported on the Nightmare Log		Change from baseline to 2-week posttreatment
Secondary	Total score on the Insomnia Severity Index (ISI)		Change from baseline to 2-week posttreatment
Secondary	Total score on the Clinician Administered PTSD Scale (CAPS-5)		Change from baseline to 2-week posttreatment
Secondary	Total score on the PTSD Checklist -DSM-5 (PCL-5)		Change from baseline to 2-week posttreatment
Secondary	Total score on the Patient Health Questionnaire (PHQ-9)		Change from baseline to 2-week posttreatment