Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Acupuncture for the Treatment of Trauma Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320138
• Other study ID #: HO0001-051-0002
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2006
• Last updated: January 11, 2012
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: January 2012
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Acupuncture, using Chinese Medicine methodology
4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments

Locations

Country	Name	City	State
United States	Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Federal government (congressional allocation)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	baseline, 3 months	No
Secondary	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.	baseline, 3 months	No
Secondary	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).	baseline, 3 months	No
Secondary	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.	baseline, 1 month, 2 months, 3 months	No
Secondary	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.	baseline, 1 month, 2 months, 3 months	No
Secondary	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.	tracked daily throughout 3-month study period	No
Secondary	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.	baseline, 3 months	No
Secondary	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.	baseline, 1 month	No

External Links

•   Deployment Health Clinical Center