Acupuncture for PTSD (PTSD ACU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02869646|
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : April 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Procedure: Procedure: Acupuncture Procedure: Procedure: Sham acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture for PTSD in Combat Veterans|
|Actual Study Start Date :||April 5, 2018|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Verum acupuncture
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Procedure: Acupuncture
Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
Other Name: Traditional Chinese Medicine
Sham Comparator: Minimal needling
shallow and non-acupoint needles at same number of sites
Procedure: Procedure: Sham acupuncture
Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
Other Name: Placebo acupuncture
- Change in PTSD symptom severity on the Clinician Administered PSTD Scale - CAPS 5 from before to after treatment [ Time Frame: Baseline, 6 weeks, 12 weeks, and 13 weeks (1-month after end of treatment) ]The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of >2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. A DSM-5 CAPS cutoff score of >26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
- Change in EMG eyeblink startle from before to after treatment [ Time Frame: Baseline, 12 weeks ]The startle response, measured with electromyography (EMG) of the eyeblink, provides an ideal translational tool to investigate fear conditioning and extinction, since the amygdala is directly connected with the startle circuit. The raw EMG signal will be recorded at a rate of 1000 Hz throughout the experimental session using a 28 Hz high pass and 500 Hz low pass filter (as recommended by guidelines for human eyeblink startle in Blumenthal et al., 2005; Psychophysiology, 42:1-15). Raw signals will be stored and exported for analysis in microvolt ( V) values.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869646
|Contact: Ruth Alpert, BS||(562) 826-8000 ext email@example.com|
|Contact: Michael Hollifield, MD||(562) 826-8000||Michael.Hollifield@va.gov|
|United States, California|
|VA Long Beach Healthcare System, Long Beach, CA||Recruiting|
|Long Beach, California, United States, 90822|
|Contact: Tamara H Bon, BA 562-826-8000 Tamara.Bon@va.gov|
|Contact: An-Fu Hsiao, MD (562) 826-8000 ext 7212 firstname.lastname@example.org|
|Principal Investigator: Michael Hollifield, MD|
|Principal Investigator:||Michael Hollifield, MD||VA Long Beach Healthcare System, Long Beach, CA|