- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055354
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Acupuncture Diagnosis and Treatment of DSM-IV PTSD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will evaluate: 1) the TCM diagnostic differentiation patterns of people who have PTSD as defined by the Diagnostic and Statistical Manual, 4th edition; 2) if an acupuncture treatment approach is acceptable to people with PTSD; and 3) if an acupuncture treatment approach is associated with a reduction in PTSD symptoms that is comparable to that of standard treatments. Because symptoms of depression, insomnia, and pain are often associated with PTSD, we will also evaluate the potential benefit of an acupuncture approach to depression, insomnia, and pain symptoms in people with PTSD.
Patients in this study will be randomized to one of three groups. Group A will receive acupuncture therapy. Group B will receive standard Cognitive Behavior Therapy. Group C is a control group and will receive no treatment. Patients in Groups A and B will undergo a total of 24 hours of therapy over the 3 month study course. All patients will have five nontherapeutic study visits; these visits will address diagnosis and assessment. Study visits will include assessments of PTSD symptoms, sleep symptoms, and level of impairment.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico Health Sciences Center- Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- DSM-IV diagnosis of PTSD
- Stage I PTSD symptoms
- PTSD Symptom Scale-Self Report (PSS-SR) score > 16
- Meets PSS-SR diagnostic criteria
Exclusion Criteria
- Stage I substance abuse and/or dependence in the past 6 months
- Psychotic disorder
- Inability to commit to treatment or wait-list conditions
- Current treatment specifically for PTSD
- Certain medical conditions, including thyroid disease, class IV heart failure, active cancer treatment, and uncontrolled diabetes
- Pregnant
- Use of benzodiazepines, narcotics, opiates, narcotic antagonists, sleep medication, muscle relaxants, analgesics, or sedatives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001229-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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