Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel

NCT ID: NCT00320138

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-10-31

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

Group Type: ACTIVE_COMPARATOR

Acupuncture, using Chinese Medicine methodology

Intervention Type: PROCEDURE

4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments

Wait List

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture, using Chinese Medicine methodology

4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal government (congressional allocation)

UNKNOWN

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Charles Engel

Dir, Deployment Health Clinical Center, WRNMMC; Associate Professor, psychiatry, USUHS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles C Engel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed National Military Medical Center

Locations

Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

HO0001-051-0002

Identifier Type: -

Identifier Source: org_study_id