Digital Biofeedback Device Shown to Reduce PTSD

Road-side bomb explosion in Afghanistan (Stephen Szczurek, U.S. Air Force).

9 Sept. 2021. Results from a clinical trial show an electronic device reporting carbon dioxide content in breath helps people with PTSD reduce symptoms of the disorder. Findings from the trial testing the device made by Freespira Inc. in Kirkland, Washington appear in the 1 Sept. issue of the Journal of Applied Psychophysiology and Biofeedback.

PTSD is a chronic debilitating condition traced to fearful or dangerous experiences — such as military combat — that lead to recurring flashbacks, fearful thoughts, or dreams that interfere with everyday routines and relationships. Symptoms can also include avoidance of situations that remind the individual of fearful experiences, difficulty sleeping, angry outbursts, distorted guilt or blame feelings, and negative thoughts about oneself. Current treatments for PTSD, according to National Institute of Mental Health, are mainly psychotherapy or medications, or both.

The Freespira device was originally designed to provide objective physiological feedback to people with panic attacks, often marked by hyperventilating. As reported by Science & Enterprise in February 2017, the device has sensors that measure and report CO2 concentrations and respiration rate in exhaled breath, with data reported on a tablet app. Individuals use the device twice a day for 17 minutes to stabilize breathing patterns and reduce the fear associated with panic attacks. Results from a clinical trial at that time show the Freespira device reduces panic attack severity as much as 12 months following treatment.

The new study tests the Freespira device as a tool for people with PTSD to reduce their symptoms. The paper’s authors, led by Michael Ostacher, professor of psychiatry and behavioral sciences at Stanford University, note that carbon dioxide hypersensitivity in people with PTSD is similar to panic attacks, with seven in 10 individuals with PTSD also experiencing panic attacks.

Combat veterans and sexual assault victims

The clinical trial enrolled 55 participants at a Veterans Administration facility in Palo Alto, California, with 65 percent of participants male and 35 percent female. About three in 10 participants (29%) traced their PTSD to military combat, with a few more (33%) victims of sexual assaults. Seven in 10 participants (71%) were military veterans. Participants were given the Freespira device, which they used twice a day for four weeks.

The study team measured participants’ scores on the standard CAPS-5 rating scale of PTSD symptoms, administered by a clinician, at the beginning of the study, then two and six months following the four-week treatment period. The trial had no separate control or comparison group.

Some 48 participants completed the four-week treatment, with 42 reporting results two months later and 38 reporting six months later. The study team defined in advance a response to treatment as a reduction of six or more points on the CAPS-5 rating scale, and remission as scores of 25 points or lower on the scale. Results show after two months following treatment, 88 percent of participants show some response from using the Freespira device, with nearly half achieving remission. Average CAPS-5 scores among participants fell from 49.5 to 27.1 points. Average CAPS-5 scores continued at about this level after six months following treatment.

“There is a need for safe, tolerable, acceptable, and effective treatments for the symptoms of PTSD,” says Ostacher in a Freespira Inc. statement, “that can be easily and widely disseminated for use in a patient’s home, including to rural residents who have difficulty accessing in-person services. The combination of clinical improvement to six months and high adherence and participant satisfaction rates suggests that this non-invasive, digital therapeutic is a promising intervention for PTSD.”

The Freespira or precursor devices were cleared by FDA as a treatment for panic attacks in 2013, and for PTSD in 2018.

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