Posttraumatic Stress Disorder (PTSD)Phase 1NCT00320138
Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel
A Phase 1 study testing Acupuncture, using Chinese Medicine methodology in people with Posttraumatic Stress Disorder (PTSD), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Acupuncture, using Chinese Medicine methodology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Deployment Health Clinical Center, WRNMMC/USUHS Dept. of Psychiatry
Bethesda, Maryland, 20889
About this study
Official title: Acupuncture for the Treatment of Trauma Survivors
The purpose of this study is to determine the effectiveness of acupuncture as a treatment for Posttraumatic Stress Disorder (PTSD) among military personnel.
Read the 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)
- Being tested
- Acupuncture, using Chinese Medicine methodology
- Keywords
- PTSD, Posttraumatic Stress, Acupuncture, Randomized Controlled Trial, Complementary medicine, Alternative medicine, Chinese medicine, military healthcare
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture, using Chinese Medicine methodologyProcedure or surgery
4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Not described Receives: Procedure: Acupuncture, using Chinese Medicine methodology |
| Wait List | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 month, 2 months, and 3 months
Secondary outcomes (8)
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.
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
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).
Measured: baseline, 3 months
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.
Measured: baseline, 1 month, 2 months, 3 months
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.
Measured: baseline, 1 month, 2 months, 3 months
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.
Measured: tracked daily throughout 3-month study period
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.
Measured: baseline, 3 months
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.
Measured: baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Federal government (congressional allocation)
- Responsible party
- Principal investigator, Charles Engel, Uniformed Services University of the Health Sciences
- Investigators
- Charles C Engel, MD, MPH, Principal investigator, USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320138
- Sponsor's protocol ID
- HO0001-051-0002
- Status last verified
- Jan 2012
- First submitted
- 27 Apr 2006
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Trauma Survivors
- ClinicalTrials.gov ID
- NCT00320138
- Acronym / sponsor ID
- HO0001-051-0002
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, Posttraumatic Stress, Acupuncture, Randomized Controlled Trial, Complementary medicine, Alternative medicine, Chinese medicine, military healthcare
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Federal government (congressional allocation)
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Procedure: Acupuncture, using Chinese Medicine methodology |
| Wait List | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture, using Chinese Medicine methodology4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments | Procedure or surgery | Acupuncture |
Primary outcome
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.
8 secondary outcomes
Clinician-Administered PTSD Scale
Time frame: baseline, 3 months
The Trauma History Questionnaire
Time frame: baseline, 3 months
SF-36-Revised
Time frame: baseline, 3 months
Beck Depression Inventory
Time frame: baseline, 1 month, 2 months, 3 months
Numeric Rating Scale for Pain
Time frame: baseline, 1 month, 2 months, 3 months
PTSD Life Chart Method (PTSD-LCM)
Time frame: tracked daily throughout 3-month study period
Alcohol Use Disorder Identification Test
Time frame: baseline, 3 months
Diagnostic evaluation by blind assessing acupuncturist
Time frame: baseline, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles C Engel, MD, MPH principal investigator
USUHS Dept. of Psychiatry/DoD Deployment Health Clinical Center, Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture, using Chinese Medicine methodology in people with Posttraumatic Stress Disorder (PTSD), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL) (time frame: baseline, 1 month, 2 months, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.