Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00868517

Purpose

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.

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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Will receive true group ear acupuncture.	Other: true group ear acupuncture Will receive the true group ear acupuncture intervention
Sham Comparator: 2 Will receive sham group ear acupuncture	Other: Sham group ear acupuncture Will receive sham group ear acupuncture intervention
No Intervention: 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868517

Locations

United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

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:	September 22, 2011
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 February 09, 2012