Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorPaul Crawford
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dragons acupuncture
Other interventionThe 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.
Dragons acupressure
Other interventionThe 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.
Dragons placebo
Other interventionThe 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Sham comparator 1 intervention
Group C: Group 3Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
visit 1 (week 0)2
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.
Time frame
visit 6 (week 8)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.
Time frame
visit 1 (week 0)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.
Time frame
visit 3 (week 2)Secondary outcomes
1
microRNA biomarkers
Changes in microRNA (miRNA) serum biomarkers miRNA-518f-3p, miRNA-486-5p, miRNA-let-7b, miRNA-220, and miRNA-433.
Time frame
visit 1 (week 0)2
microRNA biomarkers
Changes in microRNA (miRNA) serum biomarkers miRNA-518f-3p, miRNA-486-5p, miRNA-let-7b, miRNA-220, and miRNA-433.
Time frame
visit 6 (week 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Paul Crawford
Lead sponsor
Mike O'Callaghan Military Hospital
Sponsor institution
Source ClinicalTrials.gov