Status:
COMPLETED
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Stress Disorders, Post-Traumatic
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Fr...
Detailed Description
Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia. Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy...
Eligibility Criteria
Inclusion
- Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
- Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
- Diagnosis of insomnia made after PTSD diagnosis; and
- If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
Exclusion
- Does not speak English;
- Not competent to sign informed consent;
- History of moderate or severe traumatic brain injury
- Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
- Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
- History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above).
- Received acupuncture during past 3 months.
- On Coumadin, Heparin, or Lovenox
- Pregnancy
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00868517
Start Date
October 1 2009
End Date
December 1 2011
Last Update
April 28 2015
Active Locations (1)
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1
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States, 20422