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Efficacy of a Brief Nightmare Treatment for Veterans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220401
First Posted: October 13, 2010
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lisa Cromer, University of Tulsa
  Purpose
The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation Therapy (ERRT) has on nightmares and associated problems in veterans.

Condition Intervention
Sleep Disorders PTSD Suicide Behavioral: exposure, relaxation, and rescription therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Brief Nightmare Treatment for Veterans

Further study details as provided by Lisa Cromer, University of Tulsa:

Primary Outcome Measures:
  • Number of Nights With Nightmares [ Time Frame: pre, one week, two months ]
    This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).

  • Clinician Administered PTSD Scale [ Time Frame: pre, one week, two months ]

    This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 - 4). This study utilized the "FI/I2" rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis.

    Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD.


  • Past Week Nightmare Frequency [ Time Frame: pre, one week, two months ]
    This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).


Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: Baseline, 1 week, 2 months ]
    This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 - 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.


Enrollment: 21
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ERRT-M
Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
Behavioral: exposure, relaxation, and rescription therapy
veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)

Detailed Description:

The purpose of the proposed pilot study is to extend previous findings regarding the impact of a brief cognitive behavioral treatment for chronic nightmares by examining the emotional, cognitive, behavioral, and health-related changes following treatment. Experiencing a traumatic event may initiate or exacerbate the occurrence of nightmares. Indeed, sleep disturbance, including nightmares, is considered a hallmark of posttraumatic stress disorder (PTSD). Nightmares have been related to a variety of factors including stress, medications, trauma, and substance use. Among veterans, especially combat veterans or those reporting sexual assaults, symptoms of traumatic stress and nightmares are extremely common. Few studies have investigated the efficacy of nightmare treatment in a veteran population, and the impact of nightmare treatment on suicidal ideation has never been assessed.

Imagery Rehearsal Treatment (IRT) has received increased attention in the past decade for use with chronic nightmares. Studies suggest that the treatment is promising for the reduction of frequency and intensity of chronic nightmares in trauma exposed persons and may have a generalized impact on symptoms of posttraumatic stress disorder and depression and quality/quantity of sleep, although there is mixed evidence for sleep improvement among veterans. The principal investigator has completed two randomized controlled trials of a modified version of IRT, Exposure, Rescripting, and Relaxation Treatment (ERRT) and is currently conducting a third randomized controlled trial (Davis, 2008; Davis & Wright, 2007). The current randomized controlled trial is comparing ERRT to an active treatment (relaxation). Results demonstrated positive treatment response. Although these trials have included some veteran participants, veterans have not been studied as a group using this protocol. The purpose of this prospective study is to conduct a pre- and post-treatment comparison of suicidal ideation and posttraumatic, depressive, and health symptoms in a single group of veterans.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: veteran/military, 18+ years old, english proficiency, nightmares once per week, exposure to a criterion A traumatic event -

Exclusion Criteria: under 18, psychotic illness, mental retardation, imminent suicidal intent

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220401


Locations
United States, Oklahoma
The University of Tulsa
Tulsa, Oklahoma, United States, 74104
Sponsors and Collaborators
University of Tulsa
Investigators
Principal Investigator: Noelle Balliett, MA The University of Tulsa
  More Information

Responsible Party: Lisa Cromer, PI, University of Tulsa
ClinicalTrials.gov Identifier: NCT01220401     History of Changes
Other Study ID Numbers: TU1107
First Submitted: October 11, 2010
First Posted: October 13, 2010
Results First Submitted: March 29, 2014
Results First Posted: August 8, 2014
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Lisa Cromer, University of Tulsa:
Nightmare
PTSD
Posttraumatic stress disorder
Suicide
Exposure Relaxation Rescription Therapy
Sleep

Additional relevant MeSH terms:
Suicide
Sleep Wake Disorders
Parasomnias
Self-Injurious Behavior
Behavioral Symptoms
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders