NCT02506595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

June 29, 2015

Last Update Submit

April 1, 2019

Conditions

Nightmares

Outcome Measures

Primary Outcomes (1)

  • Number of nightmares reported on the Nightmare Log

    Change from baseline to 2-week posttreatment

Secondary Outcomes (4)

  • 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

Study Arms (2)

ERRT-M for Nightmares

EXPERIMENTAL

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

Behavioral: ERRT-M for Nightmares

Waitlist control

NO INTERVENTION

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.

Interventions

ERRT-M for NightmaresBEHAVIORAL

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.

Also known as: Exposure Relaxation & Rescripting
ERRT-M for Nightmares

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Related Publications (1)

  • 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.

    PMID: 31957648DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 23, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)