Adjunctive Biofeedback Intervention for Operation Iraqi Freedom/Operation Enduring Freedom (OIF-OEF) Post Traumatic Stress Disorder (PTSD)
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Objective:

      The aims are to examine the feasibility and acceptability of a handheld biofeedback device as
      an adjunct treatment for Post Traumatic Stress Disorder (PTSD) and to estimate its clinical
      effect size. A recent summary of 22 studies on OIF/OEF (Operation Iraqi Freedom/Operation
      Enduring Freedom) veterans revealed that many individual and system factors (e.g., stigma,
      concern about promotion/employment, lack of providers) prevented access to mental health
      services. For veterans who did seek help, the largest treatment trials of pharmacologic,
      outpatient psychotherapy, and residential treatment programs were not very effective.
      Currently, prolonged exposure therapy is the most validated PTSD treatment. The VHA enrollees
      from OIF/OEF are more likely to live in rural areas, hindering them from pursuing treatment
      due to travel distance and time commitment. Thus, new treatments and delivery methods are
      urgently needed.

      A substantial body of 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 is a promising adjunct
      treatment for autonomic arousal disorders. The StressEraser, a HRV/RSA biofeedback device, is
      indicated for relaxation, relaxation training, and stress reduction. This small handheld
      device measures and displays real-time RSA via an infrared finger sensor.

      Research Plan:

      The investigators were able to randomize 16 OIF/OEF veterans receiving care for PTSD at CAVHS
      community-based outpatient clinics (CBOCs) to a 24-week course of StressEraser use (N=8)
      versus usual care (N=8). A trouble-shooting phone call to participants occurred at 6 weeks.
      Follow-up clinical assessments occurred at 12 and 24 weeks.

      Methods:

      The baseline assessment consisted 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), and a quality of life measure (Quality of Well-Being Scale-Self
      Administered [QWB-SA]). In addition, psychophysiologic assessment of reactivity and
      attentional bias to combat-related PTSD relevant stimuli occurred through virtual reality
      (VR) and acoustic startle stimuli at the North Little Rock psychophysiologic reactivity lab.
      The StressEraser group was trained to operate the device at baseline and instructed to use it
      for 5-20 minutes daily before bedtime for 24 weeks.

      At six weeks, a research assistant phoned the StressEraser group to address any problems with
      the device and the usual care group to insure adherence with ongoing treatment. The 12-week
      assessment involved phoning both groups to administer the psychometric measures (CAPS, PHQ-9,
      and QWB-SA). At 24 weeks, the sample returned to the lab for administration of the
      psychometric measures and assessment of psychophysiologic reactivity.

      The subjects in the StressEraser group returned the device. The time spent using the
      StressEraser and the total number of resonant frequency respirations were the feasibility
      measures. The StressEraser logged the date, time, and duration of use and the amount of
      resonant frequency breathing, which is the resonance between the respiratory and baroreflex
      rhythms, the two primary sources of cardiac stimulation. Acceptability was measured through a
      short debriefing interview.
    

Detailed description: 
      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.
    

Intervention name(s): StressEraser
Intervention type(s): Device
Intervention description(s): A hand-held biofeedback device that facilitates resonant frequency of respiration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Combat; Biofeedback; Psychophysiology