Clinical trial NCT05881174: Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Official title: Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Acupuncture
PTSD
PCL-5 Questionnaire
Lead sponsor: Malcolm Grow Medical Clinics and Surgery Center
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2023-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 3 arm non-randomized, crossover-design clinical investigation using "rescue" acupuncture for the treatment of PTSD symptoms. Each patient receiving rescue acupuncture for PTSD will be their own "control."
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Active duty and retired military referred from a participating Mental Health Clinic

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Exclusion Criteria:

Pregnancy Participated in a form of acupuncture in the last 3 months

Primary outcomes:
measure: The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis
timeFrame: 6 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Morningside
country: United States
facility: Malcom Grow Medical Clinics and Surgery Center
state: Maryland
Study officials:
affiliation: Malcolm Grow Medical Clinics and Surgery Center
name: Richard C. Niemtzow, MD, PhD, MPH
role: STUDY_CHAIR
affiliation: Malcolm Grow Medical Clinics and Surgery Center
name: Songxuan Zhou Niemtzow, MD, LAc
role: STUDY_DIRECTOR
References: