Clinical trial NCT01314612: Initial Study of Insomnia/Nightmare Group Treatment for Posttraumatic Stress Disorder (PTSD)
Official title: An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Nightmares
Posttraumatic Stress Disorder
Keywords: Insomnia
group psychotherapy
nightmares
PTSD
posttraumatic stress disorder
Veterans
cognitive-behavioral intervention
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
First posted: 2011-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index, with Addendum for PTSD
timeFrame: baseline and 20 weeks
measure: Nightmare Effects Survey
timeFrame: baseline and 20 weeks
measure: Posttraumatic Stress Disorder Checklist- Stressor Specific Version
timeFrame: baseline and 20 weeks
Secondary outcomes:
measure: Clinician Administered PTSD Scale
timeFrame: baseline and 10 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Robert D Beck, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Michael E. DeBakey VA Medical Center
name: Whitney L Brown, Psy.D
role: PRINCIPAL_INVESTIGATOR
References: