Clinical trial NCT00320138: Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
Official title: Acupuncture for the Treatment of Trauma Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD
Posttraumatic Stress
Acupuncture
Randomized Controlled Trial
Complementary medicine
Alternative medicine
Chinese medicine
military healthcare
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Federal government (congressional allocation)
First posted: 2006-05-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: PTSD Checklist (PCL)
timeFrame: baseline, 1 month, 2 months, and 3 months
Secondary outcomes:
measure: Clinician-Administered PTSD Scale
timeFrame: baseline, 3 months
measure: The Trauma History Questionnaire
timeFrame: baseline, 3 months
measure: SF-36-Revised
timeFrame: baseline, 3 months
measure: Beck Depression Inventory
timeFrame: baseline, 1 month, 2 months, 3 months
measure: Numeric Rating Scale for Pain
timeFrame: baseline, 1 month, 2 months, 3 months
measure: PTSD Life Chart Method (PTSD-LCM)
timeFrame: tracked daily throughout 3-month study period
measure: Alcohol Use Disorder Identification Test
timeFrame: baseline, 3 months
measure: Diagnostic evaluation by blind assessing acupuncturist
timeFrame: baseline, 1 month
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry
state: Maryland
Study officials:
affiliation: USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed National Military Medical Center
name: Charles C Engel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: