Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel - Full Text View

Sponsored by:	Henry M Jackson Foundation
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00320138

Purpose

The purpose of this study is to determine the effectiveness of acupuncture as a treatment for Posttraumatic Stress Disorder (PTSD) among military personnel.

Condition	Intervention	Phase
Posttraumatic Stress Disorder (PTSD)	Procedure: Acupuncture, using Chinese Medicine methodology	Phase I

MedlinePlus related topics: Acupuncture Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Acupuncture for the Treatment of Trauma Survivors

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

PTSD Checklist (PCL) [ Time Frame: baseline, 1 month, 2 months, and 3 months ]

Secondary Outcome Measures:

Clinician-Administered PTSD Scale [ Time Frame: baseline, 3 months ]
The Trauma History Questionnaire [ Time Frame: baseline, 3 months ]
SF-36-Revised [ Time Frame: baseline, 3 months ]
Beck Depression Inventory [ Time Frame: baseline, 1 month, 2 months, 3 months ]
Numeric Rating Scale for Pain [ Time Frame: baseline, 1 month, 2 months, 3 months ]
PTSD Life Chart Method (PTSD-LCM) [ Time Frame: tracked daily throughout 3-month study period ]
Alcohol Use Disorder Identification Test [ Time Frame: baseline, 3 months ]
Diagnostic evaluation by blind assessing acupuncturist [ Time Frame: baseline, 1 month ]

Enrollment:	55
Study Start Date:	March 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Acupuncture: Active Comparator	Procedure: Acupuncture, using Chinese Medicine methodology 4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
Wait List: No Intervention Usual Care

Detailed Description:

Untreated Posttraumatic Stress Disorder (PTSD) leads to decreased force readiness and increased health care utilization. Yet, service members with the disorder may be resistant to traditional treatments or find them undesirable because of side-effects, stigma, and long-term commitment. Acupuncture, which has few known side effects, holds promise as an effective treatment option for PTSD. Acupuncture has been shown to improve well-being and has been successfully used to treat stress, anxiety and pain conditions. In order to test the efficacy of acupuncture for treating the symptoms of PTSD—measured by the PTSD Checklist (PCL)—a 12-week, randomized, waitlist-controlled trial will be conducted using a sample of 75 active duty military personnel. Participants will receive an eight-session acupuncture treatment, and will be evaluated throughout the study by way of clinical assessments and an independent assessing acupuncturist.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active duty military personnel
Criteria met for PTSD based on Clinician-Administered PTSD Scale (CAPS) interview
A stable medication dosing regimen or therapeutic treatment schedule for at least eight (8) weeks prior to beginning the study.

Exclusion Criteria:

Acupuncture treatment within the previous 6 months
Pain greater than or equal to level 8 on the Numeric Rating Scale for Pain
Significant head injury with loss of consciousness greater than 1 hour
Uncontrolled diabetes mellitus: fasting blood glucose >180 mg/dl
Unstable or uncontrolled endocrine disorders, thyroid disease, renal failure, anemia, hemorrhagic diathesis, renovascular disease, Cushing's disease, or hyperaldosteronism
Unwillingness on the part of participants to complete all study visits and/or the daily Life Chart
Pregnancy
Scheduled surgery during the treatment phase of the study
Medical instability sufficient to warrant inpatient treatment in the medical or intensive care units
Psychiatric symptoms sufficient to warrant inpatient treatment by the clinical care team
Psychosis within the past two years
A traumatic experience, as defined by the DSM-IV criterion A for ASD/PTSD, within the past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320138

Locations

United States, District of Columbia
Deployment Health Clinical Center, Walter Reed AMC/USUHS Dept. of Psychiatry
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Henry M Jackson Foundation

Investigators

Principal Investigator:

Charles C Engel, MD, MPH

USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed AMC

More Information

Deployment Health Clinical Center This link exits the ClinicalTrials.gov site

Study ID Numbers:	HO0001-051-0002
Study First Received:	April 27, 2006
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00320138
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

PTSD
Posttraumatic Stress
Acupuncture
Randomized Controlled Trial

Complementary medicine
Alternative medicine
Chinese medicine
military healthcare

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Wounds and Injuries

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009