Back to resultsAcupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
Primary Purpose
Posttraumatic Stress Disorder (PTSD)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture, using Chinese Medicine methodology
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring PTSD, Posttraumatic Stress, Acupuncture, Randomized Controlled Trial, Complementary medicine, Alternative medicine, Chinese medicine, military healthcare
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
Sites / Locations
- Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Acupuncture
Wait List
Arm Description
Usual Care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinician-Administered PTSD Scale
The CAPS is a 30 item, clinician-administered structured interview that is often referred to as the "gold standard" for diagnosing PTSD. The CAPS measures PTSD and ASD symptoms (based on the DSM-IV symptom criteria) related to up to three traumatic events. Higher scores indicate more intense and more frequent symptoms of PTSD, while lower scores represent the absence of or less intense, less frequent symptoms of PTSD. The CAPS was used in this study as the primary diagnostic tool for PTSD at entry into the study and at the three-month follow-up, and will help validate scores on the PCL.
The Trauma History Questionnaire
]. This 24 item self-report questionnaire was designed to assess lifetime history of exposure to 23 potentially traumatic experiences including crime, disaster, and physical and sexual assaults It also contains an open-ended question for specifying other extraordinarily stressful situations or events. The data acquired using this instrument will be used to provide general data about the study sample. Additionally, the THQ will be administered at the three-month follow-up to assess the occurrence of traumatic events during the course of the study.
SF-36-Revised
The SF-36-Revised measures eight general health-related concepts, which have been shown to load into distinct physical and mental health clusters in factor analytic studies in the general population. The eight scales within the SF-36-Revised are: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health (psychological distress and psychological well-being).
Beck Depression Inventory
The BDI-II is a 21-item self-report measure that evaluates symptoms of depression. Each item is scored on a scale from 0 to 3. Total scores on BDI range from 0 to 63, with scores of less than 15 indicating normal to mild depression, scores of 15 to 30 indicating moderate depression, and scores above 30 constituting severe depression.
Numeric Rating Scale for Pain
The NRS directs participants to rate pain intensity using three, 11-point, 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales. Instructions ask participants to "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours", pain "at its worst", and "pain at its least". The NRS was used in this study to evaluate the effect of acupuncture on comorbid symptoms of pain.
PTSD Life Chart Method (PTSD-LCM)
The life-chart method is a means of illustrating the relationship of life events and treatment interventions to the longitudinal course of illness. The PTSD-LCM was designed to prospectively track primary symptoms of PTSD as well as comorbid symptoms on a daily basis. The PTSD-LCM incorporates the Ecological Momentary Assessment method in a paper-and-pencil format.
Alcohol Use Disorder Identification Test
The AUDIT was developed by the World Health Organization to identify hazardous and harmful alcohol use in adults and to serve as a brief (10-item) screening instrument for excessive drinking. It was intended to identify a broad spectrum of problem drinkers and distinguish them from both hospitalized alcoholics and from normal drinkers. The instrument was modified for our purposes to inquire about participants' behavior since returning from deployment. It was used to evaluate the effect of acupuncture on comorbid symptoms of alcohol abuse.
Diagnostic evaluation by blind assessing acupuncturist
The Assessing Acupuncturist examined the patient using TCM diagnostic criteria before the first treatment, after the first four (standardized) treatments, and again at the conclusion of treatment (after the four individualized treatments). The Assessing Acupuncturist will be blind to the treatment conditions. Identical diagnostic procedures were used for patients in the treatment group and in the wait list control group. Evaluations by the Assessing Acupuncturist were be audio-recorded to ensure that they remain blind to the treatment conditions.
Full Information
NCT ID
NCT00320138
First Posted
April 27, 2006
Last Updated
January 11, 2012
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Federal government (congressional allocation)
1. Study Identification
Unique Protocol Identification Number
NCT00320138
Brief Title
Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
Official Title
Acupuncture for the Treatment of Trauma Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Federal government (congressional allocation)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
PTSD, Posttraumatic Stress, Acupuncture, Randomized Controlled Trial, Complementary medicine, Alternative medicine, Chinese medicine, military healthcare
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Procedure
Intervention Name(s)
Acupuncture, using Chinese Medicine methodology
Intervention Description
4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
Primary Outcome Measure Information:
Title
PTSD Checklist (PCL)
Description
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.
Time Frame
baseline, 1 month, 2 months, and 3 months
Secondary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale
Description
The CAPS is a 30 item, clinician-administered structured interview that is often referred to as the "gold standard" for diagnosing PTSD. The CAPS measures PTSD and ASD symptoms (based on the DSM-IV symptom criteria) related to up to three traumatic events. Higher scores indicate more intense and more frequent symptoms of PTSD, while lower scores represent the absence of or less intense, less frequent symptoms of PTSD. The CAPS was used in this study as the primary diagnostic tool for PTSD at entry into the study and at the three-month follow-up, and will help validate scores on the PCL.
Time Frame
baseline, 3 months
Title
The Trauma History Questionnaire
Description
]. This 24 item self-report questionnaire was designed to assess lifetime history of exposure to 23 potentially traumatic experiences including crime, disaster, and physical and sexual assaults It also contains an open-ended question for specifying other extraordinarily stressful situations or events. The data acquired using this instrument will be used to provide general data about the study sample. Additionally, the THQ will be administered at the three-month follow-up to assess the occurrence of traumatic events during the course of the study.
Time Frame
baseline, 3 months
Title
SF-36-Revised
Description
The SF-36-Revised measures eight general health-related concepts, which have been shown to load into distinct physical and mental health clusters in factor analytic studies in the general population. The eight scales within the SF-36-Revised are: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health (psychological distress and psychological well-being).
Time Frame
baseline, 3 months
Title
Beck Depression Inventory
Description
The BDI-II is a 21-item self-report measure that evaluates symptoms of depression. Each item is scored on a scale from 0 to 3. Total scores on BDI range from 0 to 63, with scores of less than 15 indicating normal to mild depression, scores of 15 to 30 indicating moderate depression, and scores above 30 constituting severe depression.
Time Frame
baseline, 1 month, 2 months, 3 months
Title
Numeric Rating Scale for Pain
Description
The NRS directs participants to rate pain intensity using three, 11-point, 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales. Instructions ask participants to "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours", pain "at its worst", and "pain at its least". The NRS was used in this study to evaluate the effect of acupuncture on comorbid symptoms of pain.
Time Frame
baseline, 1 month, 2 months, 3 months
Title
PTSD Life Chart Method (PTSD-LCM)
Description
The life-chart method is a means of illustrating the relationship of life events and treatment interventions to the longitudinal course of illness. The PTSD-LCM was designed to prospectively track primary symptoms of PTSD as well as comorbid symptoms on a daily basis. The PTSD-LCM incorporates the Ecological Momentary Assessment method in a paper-and-pencil format.
Time Frame
tracked daily throughout 3-month study period
Title
Alcohol Use Disorder Identification Test
Description
The AUDIT was developed by the World Health Organization to identify hazardous and harmful alcohol use in adults and to serve as a brief (10-item) screening instrument for excessive drinking. It was intended to identify a broad spectrum of problem drinkers and distinguish them from both hospitalized alcoholics and from normal drinkers. The instrument was modified for our purposes to inquire about participants' behavior since returning from deployment. It was used to evaluate the effect of acupuncture on comorbid symptoms of alcohol abuse.
Time Frame
baseline, 3 months
Title
Diagnostic evaluation by blind assessing acupuncturist
Description
The Assessing Acupuncturist examined the patient using TCM diagnostic criteria before the first treatment, after the first four (standardized) treatments, and again at the conclusion of treatment (after the four individualized treatments). The Assessing Acupuncturist will be blind to the treatment conditions. Identical diagnostic procedures were used for patients in the treatment group and in the wait list control group. Evaluations by the Assessing Acupuncturist were be audio-recorded to ensure that they remain blind to the treatment conditions.
Time Frame
baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles C Engel, MD, MPH
Organizational Affiliation
USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed National Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
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