Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

NCT ID: NCT05881174

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2023-10-18

Brief 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).

Detailed 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.

Conditions

PTSD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Newly untreated diagnosed PTSD patients without medications

Newly untreated diagnosed PTSD patients who have not yet received any PTSD treatment for a 2-week therapy of acupuncture

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: PROCEDURE

acupuncture

Newly diagnosed PTSD patients on pharmacological therapy

Newly diagnosed PTSD patients on pharmacological therapy for a 2-week therapy of acupuncture

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: PROCEDURE

acupuncture

Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury

Newly diagnosed PTSD patients with or without medications having mild traumatic brain injury for a 2-week therapy of acupuncture

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: PROCEDURE

acupuncture

Interventions

acupuncture

acupuncture

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Malcolm Grow Medical Clinics and Surgery Center

FED

Sponsor Role: lead

Responsible Party

Richard Niemtzow

Lead Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard C. Niemtzow, MD, PhD, MPH

Role: STUDY_CHAIR

Malcolm Grow Medical Clinics and Surgery Center

Songxuan Zhou Niemtzow, MD, LAc

Role: STUDY_DIRECTOR

Malcolm Grow Medical Clinics and Surgery Center

Locations

Malcom Grow Medical Clinics and Surgery Center

Morningside, Maryland, United States

Countries

United States

Other Identifiers

20190055H

Identifier Type: -

Identifier Source: org_study_id