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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01314612
Other study ID # H-28115
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 9, 2011
Last updated March 16, 2011
Start date March 2011
Est. completion date August 2011

Study information

Verified date March 2011
Source Michael Debakey Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Cognitive-Behavioral Insomnia and Nightmare Group
Group based cognitive-behavioral therapy meeting weekly for 90 minutes over the course of 9 weeks. Utilizes stimulus control, sleep scheduling, and progressive muscle relaxation to address symptoms of insomnia. Imagery rehearsal and rescripting are used to address nightmare symptoms.

Locations

Country Name City State
United States Michael E. DeBakey VA Medical Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Michael Debakey Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pittsburgh Sleep Quality Index, with Addendum for PTSD Self report measure of sleep quality and degree to which sleep is affected by PTSD. baseline and 20 weeks No
Primary Nightmare Effects Survey Self-report assessment of psychosocial impairment resulting from experience of nightmares baseline and 20 weeks No
Primary Posttraumatic Stress Disorder Checklist- Stressor Specific Version Self-report measure of Posttraumatic Stress Disorder symptoms. baseline and 20 weeks No
Secondary Clinician Administered PTSD Scale Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder baseline and 10 weeks No
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