Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
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|ClinicalTrials.gov Identifier: NCT00320138|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : January 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder (PTSD)||Procedure: Acupuncture, using Chinese Medicine methodology||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Acupuncture for the Treatment of Trauma Survivors|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
|Active Comparator: Acupuncture||
Procedure: Acupuncture, using Chinese Medicine methodology
4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
No Intervention: Wait List
- PTSD Checklist (PCL) [ Time Frame: baseline, 1 month, 2 months, and 3 months ]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.
- Clinician-Administered PTSD Scale [ Time Frame: baseline, 3 months ]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 [ Time Frame: baseline, 3 months ]]. 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 [ Time Frame: baseline, 3 months ]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 [ Time Frame: baseline, 1 month, 2 months, 3 months ]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 [ Time Frame: baseline, 1 month, 2 months, 3 months ]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) [ Time Frame: tracked daily throughout 3-month study period ]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 [ Time Frame: baseline, 3 months ]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 [ Time Frame: baseline, 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320138
|United States, Maryland|
|Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Charles C Engel, MD, MPH||USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed National Military Medical Center|