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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Cognitive Behavioral Therapy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Acupuncture, Medicine, Chinese Traditional

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of New Mexico Health Sciences Center- Department of Psychiatry

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 26, 2003
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00055354
Brief Title
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Official Title
Acupuncture Diagnosis and Treatment of DSM-IV PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Acupuncture, Medicine, Chinese Traditional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of New Mexico Health Sciences Center- Department of Psychiatry
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

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

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