We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00868517
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : November 17, 2014
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Stress Disorders, Post-Traumatic Sleep Initiation and Maintenance Disorders Other: True group auricular acupuncture Other: Sham group auricular acupuncture Other: Wait-List Control Group

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture on PTSD-Related Insomnia
Study Start Date : October 2009
Primary Completion Date : September 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: True Group Auricular Acupuncture
Received true group auricular acupuncture twice weekly for a period of two months.
Other: True group auricular acupuncture
Received true group auricular acupuncture
Sham Comparator: Sham Group Auricular Acupuncture
Received sham group auricular acupuncture twice weekly for a period of two months.
Other: Sham group auricular acupuncture
Received sham auricular acupuncture.
Wait-List Control Group
Served as wait list control. Did not receive any acupuncture during the study period.
Other: Wait-List Control Group
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.

Outcome Measures

Primary Outcome Measures :
  1. Perceived Sleep Quality [ Time Frame: t=2 months ]

    Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings.

    ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia.

    The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality.

Secondary Outcome Measures :
  1. Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps [ Time Frame: t=2 months ]
    Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.

  2. Hypnotic Medication Use [ Time Frame: t=2 months ]
    Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).

  3. Attrition Rates [ Time Frame: t=2 months ]
    Examined attendance rates in attending group sessions to examine attrition rates.

  4. Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture [ Time Frame: t= 2 months ]
  5. Fragmented Sleep Patterns-Sleep Efficiency [ Time Frame: t=2 months ]
    Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
  2. Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (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 Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868517

United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Michelle Kennedy Prisco, MSN BC-ANP Washington DC VA Medical Center, Washington, DC
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00868517     History of Changes
Other Study ID Numbers: NRI 08-121
First Posted: March 25, 2009    Key Record Dates
Results First Posted: November 17, 2014
Last Update Posted: April 28, 2015
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
Operation Iraqi Freedom
Operation Enduring Freedom
Combat Disorders
Complementary Therapies

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases