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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nightmares

Intervention / Treatment
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* Behavioral: ERRT-M for Nightmares


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERRT-M for Nightmares<br>Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) - | Behavioral: ERRT-M for Nightmares<br>* 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.<br>* Other names: Exposure Relaxation & Rescripting;|
| No Intervention: Waitlist control<br>Participants randomized to the Waitlist control condition will be contacted once weekly for 5 weeks to monitored status and then invited to participant in treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of nightmares reported on the Nightmare Log |  | Change from baseline to 2-week posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |