Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

PTSD Clinical Trial

Official title:

Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881174
• Other study ID #: 20190055H
• Status: Completed
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: October 18, 2023

Study information

• Verified date: March 2024
• Source: Malcolm Grow Medical Clinics and Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The summary of this research study is to test the effectiveness of a rapid "rescue" acupuncture technique as a non-pharmacologic alternative treatment for the reduction of post-traumatic stress disorder (PTSD) symptoms in affected individuals as a means to improve warfighter health and enable a more rapid return to duty, especially in austere environments. Patients will receive acupuncture as a research-related course of treatment for PTSD. The PCL-5 questionnaire will be used to assess the presence and severity of PTSD symptoms. A PCL-5 questionnaire will be administered at the beginning of the first treatment of "rescue" acupuncture and after the last treatment. Following the acupuncture treatment, a PCL-5 questionnaire will be initiated at the beginning of the first week of treatment and the end of the second week of treatment at the participating Mental Health Clinic (pMHC).

Description:

"The objective is to treat three ARMS of PTSD patients: ARM 1: Newly untreated diagnosed PTSD patients referred from a participating Mental Health Clinic (pMHC) who have not yet received any PTSD treatment for a 2-week therapy of ""rescue"" acupuncture (six 30 minute sessions Monday, Wednesday, and Friday); ARM 2: Newly diagnosed PTSD patients referred from the pMHC but already placed on pharmacological therapy (i.e. Prazosin, SSRI, sedative, etc.) prior to their enrollment in the pMHC; and ARM 3: newly diagnosed PTSD patients with or without medications referred to pMHC but have a mild traumatic brain injury that does not impede their judgment ability. ARMs 2 and 3 will follow the same ""rescue"" acupuncture program as ARM 1. A PCL-5 questionnaire will be administered prior to and after ""rescue"" acupuncture. ARMs 1, 2, and 3 patients will return to the pMHC (after 2 weeks of ""rescue"" acupuncture) to start or continue pharmacological and/or non-pharmacological therapy(s) and will also be evaluated by a PCL-5 questionnaire at the start and after 2 weeks. Statistical analysis of the PCL-5 questionnaire will compare the three ARMS together as to whether acupuncture is a benefit or not to the patient following therapies received for 2 weeks in the pMHC. The lowering of the PCL-5 symptomatic questionnaire score is a favorable indication of a benefit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Active duty and retired military referred from a participating Mental Health Clinic - Exclusion Criteria: Pregnancy Participated in a form of acupuncture in the last 3 months

Related Conditions & MeSH terms

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

Intervention

Procedure:
• acupuncture
acupuncture

Locations

Country	Name	City	State
United States	Malcom Grow Medical Clinics and Surgery Center	Morningside	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Malcolm Grow Medical Clinics and Surgery Center	Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis	Data will be analyzed using SAS v 9.4. The paired samples t-test will be used to assess the difference in PCL-5 score between pre and post acupuncture treatments. The paired samples t-test will be used to assess the difference in PCL-5 score between pre and post-pharmacological or non-pharmacological treatments. The ANOVA test will be used to assess differences in PCL-5 score between pharmacological, non-pharmacological or both pharmacological and non-pharmacological treatments. Mixed models will be used to assess differences in PCL-5 score between acupuncture treatments and pharmacological.; The PCL-5 Analysis-pharmacological or both pharmacological and non-pharmacological treatment scale is a 20-item (0 = not at all, 4 = extremely) self-report measure that assesses the presence and severity of PTSD symptoms. The total severity score (min=0 and Max=80).; A PCL-5 score of 31-33 or higher suggests the patient may benefit from PTSD treatment.	6 Years