NCT00320138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

1.6 years

First QC Date

April 27, 2006

Last Update Submit

January 11, 2012

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSDPosttraumatic StressAcupunctureRandomized Controlled TrialComplementary medicineAlternative medicineChinese medicinemilitary healthcare

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist (PCL)

    The PCL is a widely used measure of PTSD symptom presence and severity among veterans. It is a 17-item measure that assesses the symptoms of PTSD listed in the DSM-IV. Respondents indicate on a 5-point scale (1-5) the degree to which they have been bothered by each symptom in the past month. The PCL-M yields a total severity score ranging from 17 to 85.

    baseline, 1 month, 2 months, and 3 months

Secondary Outcomes (8)

  • Clinician-Administered PTSD Scale

    baseline, 3 months

  • The Trauma History Questionnaire

    baseline, 3 months

  • SF-36-Revised

    baseline, 3 months

  • Beck Depression Inventory

    baseline, 1 month, 2 months, 3 months

  • Numeric Rating Scale for Pain

    baseline, 1 month, 2 months, 3 months

  • +3 more secondary outcomes

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR
Procedure: Acupuncture, using Chinese Medicine methodology

Wait List

NO INTERVENTION

Usual Care

Interventions

Acupuncture, using Chinese Medicine methodologyPROCEDURE

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

Acupuncture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Charles C Engel, MD, MPH

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dir, Deployment Health Clinical Center, WRNMMC; Associate Professor, psychiatry, USUHS

Study Record Dates

First Submitted

April 27, 2006

First Posted

May 3, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

US(1)