PTSD Study Protocol
Long title: A Double-Blind, Placebo-Controlled Study into the Efficacy of Ultra Long-Range Frequency Devices for Treatment of Post-Traumatic Stress Disorder in Adults
Lead Investigator: The National Centre for ElectroMagnetic Therapies C.I.C., a not-for-profit serving the public interest registered in England & Wales under Companies House number 11486072
Lead Sponsor: to be determined – likely crowdfunding through GoFundMe
The primary purpose of this study is to determine the efficacy of ultra long-range acoustic devices in alleviating or reducing symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults.
A total of 40 participants will be randomly assigned to either the placebo (sham) group or the active (treatment) group in equal number using the double-blind method. Treatment consists of three separate sets of high-range frequencies emitted thrice daily over a period of 90 days.
Efficacy of treatment will be evaluated via questionnaires based on the DSM-5 PCL-5 to be completed by the participants.
Detailed Study Description:
PTSD and Trauma can be caused by a number of incidents such as serving in the armed forces, serving as a first responder in the emergency services, car accidents, domestic violence, rape, and physical abuse. It is estimated that 50-70% of the UK population will experience at least one traumatic event in their lives, and that 20% of those people will develop PTSD as a result; In the UK, that is more than 6.5 million people (Ref.: https://www.ptsduk.org/ptsd-stats).
Based upon a small pilot study conducted in 2021 and ensuing preliminary research not formally conducted, a certain level of efficacy in both in-harness and subspace treatments has been determined. “In-harness” describes electromagnetic treatment given through electrodes attached to the patient or participant’s body such as in tDCMS, PEMF or Neurofeedback. “Subspace” refers to ultra long-range electromagnetic treatment (from a distance of 100+ miles). Given the fact that electromagnetic waves (also referred to as “frequencies”) beyond a certain high range do not require a medium through which to propegate (Ref.: https://www.nasa.gov/directorates/heo/scan/spectrum/overview/index.html), the variables affecting efficacy of treatment which exist outside the control of the study yet within the boundaries of observation are the level of interference within the environment (i.e. radiation), the ability of the human body to act as a receptor of ultra high-range frequencies (i.e. due to dehydration or metal implants), the ability of the human body to respond physiologically (i.e. chemical balance of the brain manipulated by third-party substances such as SSRIs) and the ability of the human mind to process changes in the patterning of consciousness.
It is the latter variable, namely developed through non-somatic ‘talking therapy’ or Cognitive Behavioural Therapy (CBT), that has been proven most clinically effective when applied in combination with somatic or non-verbal therapy e.g. Trans-Cranial Direct Current Magnetic Stimulation (tDCMS), Pulsed ElectroMagnetic Field (PEMF) therapy, yoga (Ref.: NICE Guidelines 116 [D] Evidence reviews for psychological, psychosocial and other non-pharmacological). This is the reason for including even those participants who are currently taking pharmacological or other interventions as well as undergoing non-somatic / CBT / talking therapy during the 90-day period of this study.
One additional conclusion reached in the outcome of the Ethics Committee Review conducted internally by the Lead Investigator is — upon study completion — to notify those participants randomly assigned to the placebo group that they were in the placebo group and give them the option to receive the same intervention that the treatment group were given, free of charge and free from clinical evaluation. During the course of the study, the double-blind method will not be breached; Neither the participants nor the participant coordinators will be aware of which participant has been randomly assigned to which group.
Ultra Long-Range Frequency Treatment could be an extremely cost-effective, non-drug treatment for those suffering from PTSD and symptoms from overlapping conditions such as Insomnia, General Anxiety Disorder and Depression.
Study type: Interventional
Estimated enrolment: 40 participants
Intervention model: Parallel assignment
Masking: Double (participant, investigator)
Primary purpose: Treatment
Estimated study start date: September 2023 with staggered or rolling starts
Estimated primary completion date: January 2024
Estimated study completion date: April 2024
(1) Intervention / treatment:
This group will receive thrice daily emissions of three separate sets of ultra long-range electromagnetic frequency treatment lasting 2 hours each in duration; The total hours of emissions amounts to 18 hours per day, per participant, for 90 consecutive days. The device used is ultra long-range electromagnetic generation, which can be performed with a number of machines sold on the public market by a number of manufacturers. The device used in this study is the Scientific Consciousness Interface Operations (S.C.I.O.).
(2) Sham: This group will not receive emissions.
Primary outcome measure: Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL-5) [Time Frame: Baseline to Post-treatment (90 days)]
PTSD symptoms are to be assessed with the PCL-5, a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD (Ref.: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. There will be no clinician-administered assessment.
a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.
Secondary outcome measure: Change in the PTSD symtoms measured by the PCL-5 mid-treatment [Timeframe: Baseline to mid-treatment (45 days, allowing for data submission up to 48 hours before or after the 45-day mid-treatment mark)]
Secondary outcome measure: Self-reported change in quality of sleep measured by the Bergen Insomnia Scale post-treatment [Timeframe: Baseline to post-treatment (90 days)]
Age: 18 years and older
Time elapsed since traumatic event or incident: 1 month and later
Experienced or witnessed an extremely traumatic event that involved actual or threatened death, serious injury, sexual abuse or physical abuse to the participant.
The traumatic event or the first traumatic event must have occurred more than 1 month ago.
Must be experiencing significant symptoms of PTSD as measured on the PCL-5 with a score ≥ 35.
Have a telephone or computer with internet connection in order to complete the self-assessment questionnaires.
English is the primary language.
Unable to give informed consent.
Unable to complete all three self-assessment questionnaires.
Budget (Costs and Hours)
Server, hosting, SCIO useage: 150 per participant x 40 expected = 6,000
Project management (setup, providing information, questionnaires, training, posting information): 80 hours x 35/hr = 2,800
Volunteers for coordinating participants: 5 hours per participant x 0/hr = 0 (thank you!!)
Phone + email hosting: 60/month x 6 months = 360
Dissemination in ScientDirect.com (under category “contemporary clinical trials”): 2,320
Listing on ClinicalTrials.com: Free listing + 30 hours (preparation, study protocol, correspondence) x 35/hr = 1,050 **We aren’t sure whether this will pilot study will be accepted**
Statistical calculation, dissemination on our website or other free sources: 60 hours x 35/hr = 2,100
Subtotal = 14,630 + 2.3% transaction fees
TOTAL = 14.966.49 GBP