Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00920036
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2009-06-10
Brief Title:
Adjunctive Biofeedback Intervention for Operation Iraqi FreedomOperation Enduring Freedom OIF-OEF Post Traumatic Stress Disorder PTSD
Sponsor:
Central Arkansas Veterans Healthcare System
Organization:
Central Arkansas Veterans Healthcare System
Study Overview
Official Title:
Adjunctive Biofeedback Intervention for OIF-OEF PTSD
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABIOP
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 OIFOEF Operation Iraqi FreedomOperation Enduring Freedom veterans revealed that many individual and system factors eg stigma concern about promotionemployment 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 OIFOEF 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 HRVrespiratory sinus arrhythmia RSA biofeedback is a promising adjunct treatment for autonomic arousal disorders The StressEraser a HRVRSA 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 OIFOEF veterans receiving care for PTSD at CAVHS community-based outpatient clinics CBOCs to a 24-week course of StressEraser use N8 versus usual care N8 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
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 OIFOEF Operation Iraqi FreedomOperation Enduring Freedom veterans revealed that many individual and system factors eg stigma concern about promotionemployment 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 OIFOEF 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 HRVrespiratory sinus arrhythmia RSA biofeedback is a promising adjunct treatment for autonomic arousal disorders The StressEraser a HRVRSA 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 OIFOEF veterans receiving care for PTSD at CAVHS community-based outpatient clinics CBOCs to a 24-week course of StressEraser use N8 versus usual care N8 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 OIFOEF Operation Iraqi FreedomOperation 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 418-610 received mental health services Many individual and system factors eg stigma concern about promotionemployment 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 OIFOEF 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 OIFOEF 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 HRVRSA 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 OIFOEF veterans receiving care for PTSD at CAVHS community-based outpatient clinics CBOCs to a 24-week course of StressEraser use N15 versus usual care N15 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 himher 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
A recent RAND Corporation Report summarized 22 studies of OIFOEF Operation Iraqi FreedomOperation 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 418-610 received mental health services Many individual and system factors eg stigma concern about promotionemployment 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 OIFOEF 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 OIFOEF 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 HRVRSA 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 OIFOEF veterans receiving care for PTSD at CAVHS community-based outpatient clinics CBOCs to a 24-week course of StressEraser use N15 versus usual care N15 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 himher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None