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Clinical Trials/NCT01314612
NCT01314612
Unknown
N/A

An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD

Michael E. DeBakey VA Medical Center1 site in 1 country30 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Insomnia
Sponsor
Michael E. DeBakey VA Medical Center
Enrollment
30
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index, with Addendum for PTSD
Last Updated
15 years ago

Overview

Brief Summary

Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder that develops after an extremely stressful event or events. PTSD is associated with problems falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments that do not involve taking medication have been shown to help improve problems related to sleep and nightmares. However, very few of these treatments address both sleep problems and nightmares at the same time, even though many people suffer from both problems. The purpose of this study is to examine the effectiveness of a combined treatment for sleep problems and nightmares in Veterans suffering from combat-related PTSD that is presented in a group format. The investigators hypothesize that the completion of this treatment will lead to increases in sleep quality and decreases in the frequency and severity of nightmares as measured by standard questionnaires.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
August 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in the Michael E. DeBakey VAMC Trauma Recovery Program and qualify for a diagnosis of combat-related PTSD related to service in Vietnam-era conflicts as measured by responses to the Clinician-Administered PTSD Scale (CAPS) and total score ≥ 50 on the Posttraumatic Stress Disorder Checklist Stressor Specific Version (PCL-S)
  • Have a clinically significant sleep problem as measured by a total score \> 5 on the Pittsburgh Sleep Quality Index (PSQI)
  • Have a repetitive trauma-related nightmare at least once per week on average, as measured by the Nightmare Frequency Questionnaire (NFQ), and which significantly impairs sleep as measured by response ≥ 2 on question 1a of the Nightmare Effects Survey (NES)
  • Be stable on current regimen of psychotropic medication (i.e., no changes to medications and/or dosages) if applicable
  • Must sign consent to be audio-recorded as part of the course of the treatment

Exclusion Criteria

  • Current substance dependence
  • Planned or ongoing participation in Prolonged Exposure or Cognitive Processing Therapy during treatment participation
  • Organic psychosis
  • Bipolar I disorder
  • Currently on benzodiazepine or hypnotic medication to treat sleep
  • Currently take prazosin
  • Indication of undiagnosed sleep apnea defined as score ≥ .5 across items 1, 5, and 8 of the Multivariable Apnea Risk Index
  • Uncontrolled sleep apnea

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index, with Addendum for PTSD

Time Frame: baseline and 20 weeks

Self report measure of sleep quality and degree to which sleep is affected by PTSD.

Nightmare Effects Survey

Time Frame: baseline and 20 weeks

Self-report assessment of psychosocial impairment resulting from experience of nightmares

Posttraumatic Stress Disorder Checklist- Stressor Specific Version

Time Frame: baseline and 20 weeks

Self-report measure of Posttraumatic Stress Disorder symptoms.

Secondary Outcomes

  • Clinician Administered PTSD Scale(baseline and 10 weeks)

Study Sites (1)

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