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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00920036
First received: June 10, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Post-traumatic Stress Disorder
Device: StressEraser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Biofeedback Intervention for OIF-OEF PTSD

Resource links provided by NLM:


Further study details as provided by Central Arkansas Veterans Healthcare System:

Primary Outcome Measures:
  • feasibility and acceptance using qualitative measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2010
Study Completion Date: September 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Eight subjects were trained to utilize a handheld biofeedback device
Device: StressEraser
A hand-held biofeedback device that facilitates resonant frequency of respiration
No Intervention: Arm 2
usual care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920036

Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
Principal Investigator: Timothy A Kimbrell, MD Central Arkansas Veterans Healthcare System (North Little Rock)
  More Information

No publications provided

Responsible Party: Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT00920036     History of Changes
Other Study ID Numbers: 203987
Study First Received: June 10, 2009
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Central Arkansas Veterans Healthcare System:
PTSD
Combat
Biofeedback
Psychophysiology

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014