Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

Conditions
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PTSD

Intervention / Treatment
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* Procedure: acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Newly untreated diagnosed PTSD patients without medications<br>Newly untreated diagnosed PTSD patients who have not yet received any PTSD treatment for a 2-week therapy of acupuncture | Procedure: acupuncture<br>* acupuncture<br>|
| Active Comparator: Newly diagnosed PTSD patients on pharmacological therapy<br>Newly diagnosed PTSD patients on pharmacological therapy for a 2-week therapy of acupuncture | Procedure: acupuncture<br>* acupuncture<br>|
| Active Comparator: Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury<br>Newly diagnosed PTSD patients with or without medications having mild traumatic brain injury for a 2-week therapy of acupuncture | Procedure: acupuncture<br>* acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, PTSD, PCL-5 Questionnaire