Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma

NCT05516862 | Recruiting

• 1 other identifier: USUHS.2022-101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post-Traumatic Stress Disorder (PTSD).

Conditions

PTSD; Post Traumatic Stress Disorder; Acupuncture

Keywords

PTSD; DRAGONS; family medicine residency

Outcome Measures

Primary Outcomes (7)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS-5 is a structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The CAPS-5 will be applied for its first purpose in this study. The instrument produces a total symptom severity score by summing severity scores for the 20 DSM-5 PTSD symptoms and symptom cluster severity scores calculated by summing individual item severity scores for symptoms corresponding to a given DSM-5 cluster. There are five symptom cluster severity scores: Criterion B, Criterion C, Criterion D, Criterion E and Criterion disassociation.

  visit 1 (week 0)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS-5 is a structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The CAPS-5 will be applied for its first purpose in this study. The instrument produces a total symptom severity score by summing severity scores for the 20 DSM-5 PTSD symptoms and symptom cluster severity scores calculated by summing individual item severity scores for symptoms corresponding to a given DSM-5 cluster. There are five symptom cluster severity scores: Criterion B, Criterion C, Criterion D, Criterion E and Criterion disassociation.

  visit 6 (week 8)

• PTSD checklist for DSM-5 (PCL-5)

  PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.

  visit 1 (week 0)

• PTSD checklist for DSM-5 (PCL-5)

  PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.

  visit 3 (week 2)

• PTSD checklist for DSM-5 (PCL-5)

  PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.

  visit 4 (week 3)

• PTSD checklist for DSM-5 (PCL-5)

  PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.

  visit 5 (week 4)

• PTSD checklist for DSM-5 (PCL-5)

  PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.

  visit 6 (week 8)

Secondary Outcomes (2)

• microRNA biomarkers

  visit 1 (week 0)

• microRNA biomarkers

  visit 6 (week 8)

Study Arms (3)

Group 1

EXPERIMENTAL

Script followed by Dragons Acupuncture (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes).

Other: Dragons acupuncture

Group 2

SHAM COMPARATOR

Script followed by Dragons sham acupressure placed at the Dragons points (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes).

Other: Dragons acupressure

Group 3

PLACEBO COMPARATOR

Script followed by Acupuncturist lightly touching Dragons points (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes).

Other: Dragons placebo

Interventions

Dragons acupuncture OTHER

The treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons. Subject will lay on your stomach and have 7 needles placed in head, upper back, lower back and ankles.

Group 1

Dragons acupressure OTHER

The treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons. Subject will lay on your stomach and have 7 small acupressure adhesive bandages placed on head, upper back, lower back and ankles.

Group 2

Dragons placebo OTHER

The treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons. Subject will lay on your stomach and the doctor will touch 7 points on head, upper back, lower back and ankles.

Group 3

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active Duty members and DoD beneficiaries(i.e. former military, spouse, dependent child), 18-65 years old
• Meeting the criteria for PTSD based on PCL-5 (past month scores) score of 31 or higher
• At least 1 positive response to at least one item on the LEC-5.

You may not qualify if:

• Pregnant, may be pregnant, or attempting to become pregnant. There areno known risks of this acupuncture in pregnant patients; however, we will exclude pregnancy due to the location of the needles (right over the uterus in 3rd trimester) and risk of exacerbating anxiety that may cause stress on the baby. Subjects will be told to let us know if they become pregnant so we can disenroll them from the study.
• Prior treatment with Dragons acupuncture
• History of hospitalization for mental health reasons within the last year
• Active Suicidal thoughts (is currently considering suicide or has a plan) or suicide attempt within the last year. This will be assessed by direct questioning.
• Is currently receiving acupuncture or other non-medication treatments specifically for PTSD (patients can elect to forgo PTSD treatments during the study period and then resume after the study period is over; ie halt therapy during the study period)
• Legally Authorized Representatives will not be utilized in this study
• \*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Sponsors & Collaborators

• Paul Crawford: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

RECRUITING

Related Publications (15)

• Van, K. B. A. (2014). The body keeps the score: Brain, mind, and body in the healing of trauma. p 44-46

  BACKGROUND

• Vitale A, Byma L, Sun S, Podolak E, Wang Z, Alter S, Galfalvy H, Geraci J, Langhoff E, Klingbeil H, Yehuda R, Haghighi F, Feder A. Effectiveness of Complementary and Integrative Approaches in Promoting Engagement and Overall Wellness Toward Suicide Prevention in Veterans. J Altern Complement Med. 2021 Mar;27(S1):S14-S27. doi: 10.1089/acm.2020.0245.

  PMID: 33788604 BACKGROUND

• Jiang Y, Hao Y, Zhang Y, Liu J, Wang X, Han J, Fang J, Zhang J, Cui C. Thirty minute transcutaneous electric acupoint stimulation modulates resting state brain activities: a perfusion and BOLD fMRI study. Brain Res. 2012 May 31;1457:13-25. doi: 10.1016/j.brainres.2012.03.063. Epub 2012 Apr 3.

  PMID: 22541167 BACKGROUND

• Xiang XH, Chen YM, Zhang JM, Tian JH, Han JS, Cui CL. Low- and high-frequency transcutaneous electrical acupoint stimulation induces different effects on cerebral mu-opioid receptor availability in rhesus monkeys. J Neurosci Res. 2014 May;92(5):555-63. doi: 10.1002/jnr.23351. Epub 2014 Jan 31.

  PMID: 24482187 BACKGROUND

• Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.

  PMID: 30565342 BACKGROUND

• Hollifield M. Acupuncture for posttraumatic stress disorder: conceptual, clinical, and biological data support further research. CNS Neurosci Ther. 2011 Dec;17(6):769-79. doi: 10.1111/j.1755-5949.2011.00241.x. Epub 2011 Feb 26.

  PMID: 22070661 BACKGROUND

• Kim YD, Heo I, Shin BC, Crawford C, Kang HW, Lim JH. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials. Evid Based Complement Alternat Med. 2013;2013:615857. doi: 10.1155/2013/615857. Epub 2013 Feb 6.

  PMID: 23476697 BACKGROUND

• Sniezek DP. Community-Based Wounded Warrior Sustainability Initiative (CBWSI): an integrative medicine strategy for mitigating the effects of PTSD. J Rehabil Res Dev. 2012;49(3):ix-xix. doi: 10.1682/jrrd.2012.02.0025. No abstract available.

  PMID: 22773206 BACKGROUND

• Huang W, Johnson TM, Kutner NG, Halpin SN, Weiss P, Griffiths PC, Bliwise DL. Acupuncture for Treatment of Persistent Disturbed Sleep: A Randomized Clinical Trial in Veterans With Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. J Clin Psychiatry. 2018 Dec 11;80(1):18m12235. doi: 10.4088/JCP.18m12235.

  PMID: 30549498 BACKGROUND

• Engel CC, Cordova EH, Benedek DM, Liu X, Gore KL, Goertz C, Freed MC, Crawford C, Jonas WB, Ursano RJ. Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S57-64. doi: 10.1097/MLR.0000000000000237.

  PMID: 25397825 BACKGROUND

• King CH, Moore LC, Spence CD. Exploring Self-Reported Benefits of Auricular Acupuncture Among Veterans With Posttraumatic Stress Disorder. J Holist Nurs. 2016 Sep;34(3):291-9. doi: 10.1177/0898010115610050. Epub 2015 Nov 3.

  PMID: 26530240 BACKGROUND

• Hull A, Brooks Holliday S, Eickhoff C, Sullivan P, Courtney R, Sossin K, Adams A, Reinhard M. Veteran participation in the integrative health and wellness program: Impact on self-reported mental and physical health outcomes. Psychol Serv. 2019 Aug;16(3):475-483. doi: 10.1037/ser0000192. Epub 2018 Apr 5.

  PMID: 29620393 BACKGROUND

• Bremner JD, Gurel NZ, Wittbrodt MT, Shandhi MH, Rapaport MH, Nye JA, Pearce BD, Vaccarino V, Shah AJ, Park J, Bikson M, Inan OT. Application of Noninvasive Vagal Nerve Stimulation to Stress-Related Psychiatric Disorders. J Pers Med. 2020 Sep 9;10(3):119. doi: 10.3390/jpm10030119.

  PMID: 32916852 BACKGROUND

• de Kloet CS, Vermetten E, Geuze E, Kavelaars A, Heijnen CJ, Westenberg HG. Assessment of HPA-axis function in posttraumatic stress disorder: pharmacological and non-pharmacological challenge tests, a review. J Psychiatr Res. 2006 Sep;40(6):550-67. doi: 10.1016/j.jpsychires.2005.08.002. Epub 2005 Oct 7.

  PMID: 16214171 BACKGROUND

• Thrivikraman KV, Zejnelovic F, Bonsall RW, Owens MJ. Neuroendocrine homeostasis after vagus nerve stimulation in rats. Psychoneuroendocrinology. 2013 Jul;38(7):1067-77. doi: 10.1016/j.psyneuen.2012.10.015. Epub 2012 Nov 16.

  PMID: 23159723 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Amanda Crawford, MS

CONTACT

7026533600; amanda.j.crawford.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)