Post-traumatic Stress Disorder Clinical Trial
— ABIOPOfficial title:
Adjunctive Biofeedback Intervention for OIF-OEF PTSD
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 2012 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - OIF/OEF veterans - diagnosed with PTSD - receiving mental health treatment at Community Based Outpatient Clinics or PTSD clinics in North Little Rock Exclusion Criteria: - diagnosis of schizophrenia - daytime dose of benzodiazepines, beta-blockers, and stimulant medication |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central Arkansas Veterans Healthcare System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | feasibility and acceptance using qualitative measures | 6 months | No | |
Secondary | Clinician-Administered PTSD Scale (CAPS) | 6 months | No |
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