Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD) - Tabular View

Tracking Information
First Received Date ^ICMJE	February 26, 2003
Last Updated Date	August 17, 2006
Start Date ^ICMJE	September 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00055354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Official Title ^ICMJE	Acupuncture Diagnosis and Treatment of DSM-IV PTSD
Brief Summary	The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine (TCM) diagnostic patterns.
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 Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Stress Disorders, Post-Traumatic
Intervention ^ICMJE	Procedure: Acupuncture Behavioral: Cognitive Behavioral Therapy
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date	May 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00055354
Responsible Party
Study ID Numbers ^ICMJE	R21 AT001229-01
Study Sponsor ^ICMJE	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP