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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Acupuncture Diagnosis and Treatment of DSM-IV PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055354
• Other study ID #: R21AT001229-01
• Status: Completed
• Phase: N/A
• First received: February 26, 2003
• Last updated: August 17, 2006
• Start date: September 2002
• Est. completion date: May 2004

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Acupuncture

Behavioral:
• Cognitive Behavioral Therapy

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center- Department of Psychiatry	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,