Clinical trial NCT02506595: A Trial of Treatment for Trauma-Related Nightmares in Active Duty Military Personnel
Official title: A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares Compared to Waitlist Control in Active Duty Military Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmares
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2015-07-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of nightmares reported on the Nightmare Log
timeFrame: Change from baseline to 2-week posttreatment
Secondary outcomes:
measure: Total score on the Insomnia Severity Index (ISI)
timeFrame: Change from baseline to 2-week posttreatment
measure: Total score on the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Change from baseline to 2-week posttreatment
measure: Total score on the PTSD Checklist -DSM-5 (PCL-5)
timeFrame: Change from baseline to 2-week posttreatment
measure: Total score on the Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to 2-week posttreatment
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R Darnall Army Medical Center
state: Texas
Study officials:
References:
citation: 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.