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Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

Primary Purpose

PTSD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Malcolm Grow Medical Clinics and Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Acupuncture, PTSD, PCL-5 Questionnaire

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Malcom Grow Medical Clinics and Surgery CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Newly untreated diagnosed PTSD patients without medications

Newly diagnosed PTSD patients on pharmacological therapy

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
May 31, 2023
Sponsor
Malcolm Grow Medical Clinics and Surgery Center
Collaborators
Uniformed Services University of the Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05881174
Brief Title
Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Official Title
Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
November 24, 2026 (Anticipated)
Study Completion Date
November 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malcolm Grow Medical Clinics and Surgery Center
Collaborators
Uniformed Services University of the Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Acupuncture, PTSD, PCL-5 Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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."
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Newly untreated diagnosed PTSD patients without medications
Arm Type
Active Comparator
Arm Description
Newly untreated diagnosed PTSD patients who have not yet received any PTSD treatment for a 2-week therapy of acupuncture
Arm Title
Newly diagnosed PTSD patients on pharmacological therapy
Arm Type
Active Comparator
Arm Description
Newly diagnosed PTSD patients on pharmacological therapy for a 2-week therapy of acupuncture
Arm Title
Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury
Arm Type
Active Comparator
Arm Description
Newly diagnosed PTSD patients with or without medications having mild traumatic brain injury for a 2-week therapy of acupuncture
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
acupuncture
Primary Outcome Measure Information:
Title
The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis
Description
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.
Time Frame
6 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard C Niemtzow, MD, PhD, MPH
Phone
240-857-4979
Email
richard.c.niemtzow.civ@health.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Elise J Greenberg, RN, LAc
Phone
240-857-4979
Email
elise.j.greenberg.civ@health.mail
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C. Niemtzow, MD, PhD, MPH
Organizational Affiliation
Malcolm Grow Medical Clinics and Surgery Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Songxuan Zhou Niemtzow, MD, LAc
Organizational Affiliation
Malcolm Grow Medical Clinics and Surgery Center
Official's Role
Study Director
Facility Information:
Facility Name
Malcom Grow Medical Clinics and Surgery Center
City
Morningside
State/Province
Maryland
ZIP/Postal Code
20762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise J Greenberg, RN, LAc
Phone
240-857-4979
Email
elise.j.greenberg.civ@health.mil
First Name & Middle Initial & Last Name & Degree
Richard Niemtzow, MD, PhD, MPH
Phone
240-857-4979
Email
richard.c.niemtzow.civ@health.mil
First Name & Middle Initial & Last Name & Degree
Richard C Niemtzow, MD, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data

Learn more about this trial

Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

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