| 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
|
| |
| |
| Recruiting |
| 60 |
| September 2011 |
| May 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- Diagnosed with PTSD per 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 Criteria:
- Does not speak English;
- Not competent to sign informed consent;
- History of traumatic brain injury;
- History of sleep apnea or restless legs syndrome;
- Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
- History of active substance abuse within past 6 months;
- Received acupuncture during past 12 months; or
- Be on Coumadin, Lovenox, or Heparin
|
| Both |
| 18 Years and older |
| No |
|
|
| 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 |