Initial Study of Insomnia/Nightmare Group Treatment for Posttraumatic Stress Disorder (PTSD)

Not Applicable

• Conditions: Insomnia; Nightmares; Posttraumatic Stress Disorder

• Registration Number: NCT01314612
• Lead Sponsor: Michael E. DeBakey VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Last Update Submitted: 2011-03-16
• Last Update Posted: 2011-03-17
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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
• Epilepsy
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index, with Addendum for PTSD	baseline and 20 weeks	Self report measure of sleep quality and degree to which sleep is affected by PTSD.
Nightmare Effects Survey	baseline and 20 weeks	Self-report assessment of psychosocial impairment resulting from experience of nightmares
Posttraumatic Stress Disorder Checklist- Stressor Specific Version	baseline and 20 weeks	Self-report measure of Posttraumatic Stress Disorder symptoms.

Secondary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale	baseline and 10 weeks	Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States