Full Text View
Tabular View
No Study Results Posted
Related Studies
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
This study is currently recruiting participants.
Study NCT00868517   Information provided by Department of Veterans Affairs
First Received: March 23, 2009   Last Updated: October 7, 2009   History of Changes

March 23, 2009
October 7, 2009
October 2009
May 2011   (final data collection date for primary outcome measure)
Sleep Quality rating as measured by Insomnia Severity Index and Morin Sleep diary [ Time Frame: t=0,1,2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00868517 on ClinicalTrials.gov Archive Site
  • Fragmented sleep patterns as measured by Morin Sleep Diary and Wrist Actigraphs [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • hypnotic medication use [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • attrition rates [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • Veteran Satisfaction Scores [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • Fragmented sleep patterns [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • hypnotic medication use [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • attrition rates [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • Veteran Satisfaction Scores [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
 
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The Effect of Acupuncture on PTSD-Related Insomnia

The purpose of this study is to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study also will examine the degree of veteran acceptance for a group ear acupuncture procedure.

Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia. Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy, and cognitive behavioral therapy. While some of these conventional treatments do improve PTSD-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma). Because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms. There is a growing body of research that shows that acupuncture may improve many health symptoms including depression, PTSD, addiction, headaches, musculoskeletal pain, and insomnia. However, to date, no study has specifically explored how acupuncture may affect PTSD-related insomnia. Because so many veterans with PTSD experience PTSD-related insomnia, and because the current conflicts in Southwest Asia are producing a new generation of combat veterans, it is critical that the VA explore innovative treatments for PTSD-related health concerns.

 
Interventional
Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
  • Stress Disorders, Post-Traumatic
  • Sleep Initiation and Maintenance Disorders
  • Other: true group ear acupuncture
    Will receive the true group ear acupuncture intervention
  • Other: Sham group ear acupuncture
    Will receive sham group ear acupuncture intervention
  • Other: True Control Group
    Will not receive any type of group ear acupuncture intervention--will serve as strict control and receive conventional care only
  • 1: Experimental
    Will receive true group ear acupuncture.
    Intervention: Other: true group ear acupuncture
  • 2: Sham Comparator
    Will receive sham group ear acupuncture
    Intervention: Other: Sham group ear acupuncture
  • 3: No Intervention
    Strict control group--will receive conventional care only.
    Intervention: Other: True Control Group
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
September 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
  2. Diagnosed with PTSD per DSM IV criteria;
  3. Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
  4. Diagnosis of insomnia made after PTSD diagnosis; and
  5. If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.

Exclusion Criteria:

  1. Does not speak English;
  2. Not competent to sign informed consent;
  3. History of traumatic brain injury;
  4. History of sleep apnea or restless legs syndrome;
  5. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
  6. History of active substance abuse within past 6 months;
  7. Received acupuncture during past 12 months; or
  8. Be on Coumadin, Lovenox, or Heparin
Both
18 Years and older
No
Contact: Bonnie B Benetato (202) 745-8000 ext 7124 bonnie.benetato@va.gov
United States
 
NCT00868517
Prisco, Michelle - Principal Investigator, Department of Veterans Affairs
NRI 08-121
Department of Veterans Affairs
 
Principal Investigator: Michelle Kennedy Prisco, MSN BC-ANP VA Medical Center, DC
Department of Veterans Affairs
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP