PTSD Clinical Study Opportunity

The National Institute of Health estimates that more than 12 million people are currently experiencing PTSD symptoms in the US.  Symptoms include panic, terror, dread, grief, insomnia, cognitive impairment, hypervigilance, paranoia, irritability, angry outbursts, startle, and trigger avoidance.  Specific demographics, including women, first responders, and military veterans, experience PTSD at higher rates than the general population.  

Alarmingly, a minimum of 60% of those seeking treatment require more than one year of care.  Per the J Clin Psychiatry  for calendar year 2018, the excess economic burden for PTSD in the United States alone was a staggering $189.5 billion for civilians and $42.7 billion for the military. 

The 2-Dooz sponsored study is a prospective, single-arm, open-label, unblinded pilot proof-of-concept study.  Its primary objective is to evaluate the safety and efficacy of using the Distress Symptoms Mitigation App over a 10-week period. The study will assess the utility of the combination of the DSM App and the Resilience Smart Ring or J2 Smart Ring as an adjunct to Cognitive Behavioral Therapy (CBT) treatment.

Highlights of the eligibility requirements include the following. Participants must be:

• Ages 18 and older

• Diagnosed with PTSD

• Currently in continuation or maintenance supportive therapy post-CBT

• Owners of an iPhone to run the Distress Mitigation App

The Distress Mitigation App and J2 or Resilience Smart Ring pre-emptively, independently, and effectively intervene distress symptoms, inclusive of those associated with PTSD.  Serving as an early warning system, the Resilience Smart Ring detects PTSD distress symptoms before a wearer becomes conscious of them.  Notification from a paired Distress Mitigation App, running on an iPhone, prompts and guides users through a scientifically proven controlled breathing exercise to preempt the presentation and/or severity of symptoms. 

By the conclusion of the study, expected benefits include the following:  

• Participants may see a clinically significant reduction in their PTSD symptoms severity (e.g., more energy, less irritability, etc.) as measured by the study surveys.  

• Participants may  be able to independently detect the onset of their PTSD symptoms earlier, and by doing so may be able to more effectively control their symptoms. 

• Participants may achieve a greater sense of control over their PTSD symptoms. 

Others may also benefit from the results of this study.  The knowledge gained from the study may benefit future treatment of PTSD and other mental health conditions involving frequent experience of distress, utilizing distress monitoring and in-the-moment prompts for the more timely initiation of effective coping strategies.

There are minimal expected risks to participating in the study, which may include boredom, loneliness, and discomfort due to answering survey questions that may be challenging.  The investigators do not guarantee that you will receive any mental health benefit as a direct result of participating in this study.

Those admitted to the study will receive a J2 or Resilience Smart Ring and the Distress Symptoms Mitigation app for free: an estimated combined retail value of $1250.

Participants are currently being recruited.