Adjunctive Biofeedback Intervention for Operation Iraqi Freedom/Operation Enduring Freedom (OIF-OEF) Post Traumatic Stress Disorder (PTSD)

The aims of this proposal are to examine the feasibility and acceptability of using a handheld biofeedback intervention as an adjunct treatment for Post Traumatic Stress Disorder (PTSD) and to estimate the effect size of the biofeedback intervention as an adjunct treatment for PTSD.

A recent RAND Corporation Report summarized 22 studies of OIF/OEF (Operation Iraqi Freedom/Operation Enduring Freedom) veterans, giving a typical range of 5-15% for veterans meeting diagnostic criteria for PTSD, with some studies reporting rates as high as 30%. Of those active duty service members meeting criteria for mental health referral based on the post-deployment health assessment, only about half (41.8-61.0%) received mental health services. Many individual and system factors (e.g., stigma, concern about promotion/employment, wait times, lack of providers) prevented access.

Historically, for those veterans who access treatment for combat-related PTSD, the largest treatment trials of pharmacologic, outpatient psychotherapy, and residential treatment programs have not shown these treatments to be very effective. More recently, the Institute of Medicine has recommended prolonged exposure therapy as the most validated of PTSD treatments. However, rural OIF/OEF veterans are hindered by travel distance and the time commitment necessary to receive such recommended treatments. The VA Office of Rural Health reported that VHA enrollees from OIF/OEF were more likely to live in rural areas. Thus, new treatments and new treatment delivery methods are urgently needed.

A substantial historic and growing preclinical literature documents autonomic nervous system (ANS) dysregulation in patients with PTSD. Preliminary results suggest that portable heart rate variability (HRV)/ respiratory sinus arrhythmia (RSA) biofeedback appears to be a promising adjunct treatment for disorders of autonomic arousal. The StressEraser, a HRV/RSA biofeedback device, is indicated for relaxation, relaxation training, and stress reduction. The StressEraser is a small handheld device that measures and displays real-time RSA, a measure of HRV, via an infrared finger sensor.

We will randomize 30 OIF/OEF veterans receiving care for PTSD at CAVHS community-based outpatient clinics (CBOC's) to a 24-week course of StressEraser use (N=15) versus usual care (N=15). The baseline assessment will consist of a screening interview for comorbid anxiety and substance use disorders, the Clinician Administered PTSD Scale (CAPS), the 9-item depression Patient Health Questionnaire (PHQ-9) to determine symptoms of depression, and a quality of life measure (Quality of Well-Being Scale-Self Administered [QWB-SA]).

In addition, subjects will participate in assessment of psychophysiologic measures in response to virtual reality (VR) and acoustic startle stimuli and attentional bias measures to combat-related PTSD relevant stimuli. Subjects in the StressEraser group will be trained to use and demonstrate proficiency in using the device at completion of the baseline assessment. These subjects will be instructed to use the StressEraser for 5-20 minutes daily before bedtime for 24 weeks. Follow-up assessments will occur at 12 and 24 weeks after baseline for both the StressEraser and usual care subjects. Subjects will be contacted by phone at 6 weeks to address any problems using the StressEraser (intervention group) and to insure adherence with ongoing treatment in the usual care group. The 12-week assessments will occur over the phone and address current symptom severity of PTSD (CAPS) and depression (PHQ-9) and health-related quality of life with the QWB-SA. The 24-week assessment will be in-person at the psychophysiologic reactivity lab in North Little Rock for repeat assessment of psychophysiologic measures through VR and acoustic startle stimuli and attentional bias measures to combat-related PTSD relevant stimuli and will include the psychometric measures. The subject will be asked to bring the StressEraser with him/her to the 24-week assessment to document the duration and frequency of use.

Feasibility will be measured by the amount of time the subject spends using the StressEraser. The StressEraser logs the date, time, and duration of use. It also logs the amount of resonant frequency breathing achieved, which is the resonance between the respiratory and baroreflex rhythms, the two primary sources of cardiac stimulation. This information can be easily downloaded from the StressEraser device. The feasibility measures will be total duration of use and total number of resonant frequency respirations.

Acceptability will be measured using a short debriefing interview at 12 weeks and a longer debriefing interview at 24 weeks. Additional measures will include change in CAPS, PHQ-9, and QWB-SA scores measured at baseline, 12, and 24 weeks and changes in psychophysiologic reactivity at 24 weeks compared to baseline.