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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02506595
Other study ID # 119-FP-15
Secondary ID HSC20150396H
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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