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

NCT00920036 | Completed

• 1 other identifier: 203987
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post-traumatic Stress Disorder

Keywords

PTSD; Combat; Biofeedback; Psychophysiology

Outcome Measures

Primary Outcomes (1)

• feasibility and acceptance using qualitative measures

  6 months

Secondary Outcomes (1)

• Clinician-Administered PTSD Scale (CAPS)

  6 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Eight subjects were trained to utilize a handheld biofeedback device

Device: StressEraser

Arm 2

NO INTERVENTION

usual care

Interventions

StressEraser DEVICE

A hand-held biofeedback device that facilitates resonant frequency of respiration

Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OIF/OEF veterans
• diagnosed with PTSD
• receiving mental health treatment at Community Based Outpatient Clinics or PTSD clinics in North Little Rock

You may not qualify if:

• diagnosis of schizophrenia
• daytime dose of benzodiazepines, beta-blockers, and stimulant medication

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Timothy A Kimbrell, MD

  Central Arkansas Veterans Healthcare System (North Little Rock)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2012
• Last Updated: July 14, 2014

Record last verified: 2014-07