Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00868517
First received: March 23, 2009
Last updated: April 16, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


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
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
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
Criteria

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 moderate or severe traumatic brain injury
  4. Start use of CPAP or BiPAP during the study.
  5. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
  6. 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).
  7. Received acupuncture during past 3 months.
  8. On Coumadin, Heparin, or Lovenox
  9. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: April 16, 2014
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 August 18, 2014