Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
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Purpose
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 Freedom. This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.
| Condition | Intervention |
|---|---|
|
Stress Disorders, Post-Traumatic Sleep Initiation and Maintenance Disorders |
Other: true group ear acupuncture Other: Sham group ear acupuncture Other: True Control Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Effect of Acupuncture on PTSD-Related Insomnia |
- 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 ]
- 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 ]
| Enrollment: | 25 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Will receive true group ear acupuncture.
|
Other: true group ear acupuncture
Will receive the true group ear acupuncture intervention
|
|
Sham Comparator: Arm 2
Will receive sham group ear acupuncture
|
Other: Sham group ear acupuncture
Will receive sham group ear acupuncture intervention
|
|
No Intervention: Arm 3
Strict control group--will receive conventional care only.
|
Other: True Control Group
Will not receive any type of group ear acupuncture intervention--will serve as strict control and receive conventional care only
|
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, 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 moderate or severe traumatic brain injury
- Start use of CPAP or 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
Contacts and Locations| United States, District of Columbia | |
| VA Medical Center, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Principal Investigator: | Michelle Kennedy Prisco, MSN BC-ANP | VA Medical Center, DC |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00868517 History of Changes |
| Other Study ID Numbers: | NRI 08-121 |
| Study First Received: | March 23, 2009 |
| Last Updated: | April 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Veterans Operation Iraqi Freedom Operation Enduring Freedom |
Combat Disorders Acupuncture Complementary Therapies |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 19, 2013