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

NCT ID: NCT02506595

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-06-30

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.

Conditions

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Nightmares

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ERRT-M for Nightmares

Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) -

Group Type EXPERIMENTAL

ERRT-M for Nightmares

Intervention Type 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.

Waitlist control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Exposure Relaxation & Rescripting

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Academy of Sleep Medicine

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carl R Darnall Army Medical Center

Fort Hood, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31957648 (View on PubMed)

Other Identifiers

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HSC20150396H

Identifier Type: OTHER

Identifier Source: secondary_id

119-FP-15

Identifier Type: -

Identifier Source: org_study_id

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