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Efficacy of a Brief Nightmare Treatment for Veterans

Primary Purpose

Sleep Disorders, PTSD, Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exposure, relaxation, and rescription therapy
Sponsored by
University of Tulsa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring Nightmare, PTSD, Posttraumatic stress disorder, Suicide, Exposure Relaxation Rescription Therapy, Sleep

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • The University of Tulsa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERRT-M

Arm Description

Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.

Outcomes

Primary Outcome Measures

Number of Nights With Nightmares
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
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
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
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.

Full Information

First Posted
October 11, 2010
Last Updated
April 22, 2019
Sponsor
University of Tulsa
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1. Study Identification

Unique Protocol Identification Number
NCT01220401
Brief Title
Efficacy of a Brief Nightmare Treatment for Veterans
Official Title
Efficacy of a Brief Nightmare Treatment for Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tulsa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, PTSD, Suicide
Keywords
Nightmare, PTSD, Posttraumatic stress disorder, Suicide, Exposure Relaxation Rescription Therapy, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERRT-M
Arm Type
Experimental
Arm Description
Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
Intervention Type
Behavioral
Intervention Name(s)
exposure, relaxation, and rescription therapy
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Number of Nights With Nightmares
Description
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).
Time Frame
pre, one week, two months
Title
Clinician Administered PTSD Scale
Description
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.
Time Frame
pre, one week, two months
Title
Past Week Nightmare Frequency
Description
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).
Time Frame
pre, one week, two months
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
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.
Time Frame
Baseline, 1 week, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noelle Balliett, MA
Organizational Affiliation
The University of Tulsa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States

12. IPD Sharing Statement

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Efficacy of a Brief Nightmare Treatment for Veterans

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