Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

• Sponsor: Biomedical Research Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00838006
• Collaborator: (none)
• Enrollment: 426
• Location: 1
• Arms: 3
• Duration (Months): 60
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Device: heart rate variability biofeedback; Device: Cognitive bias modification training; Device: Sham Comparator	N/A

Detailed Description

The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. The objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. We hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. We will compare the prevention interventions to a no intervention control group. We hypothesize that the prevalence of post-deployment PTSD will be lower in the intervention groups compared to the control group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 426 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biofeedback training Heart rate variability biofeedback training and iPod with Breath Pacer app	Device: heart rate variability biofeedback; Heart rate variability biofeedback, 3 session plus handheld device
Experimental: Cognitive bias modification training Cognitive bias modification training and iPod with cognitive bias training app	Device: Cognitive bias modification training; Cognitive bias modification training - 3 session plus handheld device
Sham Comparator: Control Group No additional resilience training and iPod with no resilience training apps	Device: Sham Comparator; Subjects received iPod without a study app and no additional resilience training

Outcome Measures

Primary Outcome Measures

1. The PTSD Checklist - Military Version [pre-deployment, 3-, and 12-months post-deployment]

   The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.

Secondary Outcome Measures

1. Patient Health Questionnaire (PHQ-9) [pre-deployment, 3-, and 12-month post-deployment]

   The PHQ-9 is a nine-item depression module that is based on DSM-IV criteria for major depression. The minimum score is 0 and the maximum score is 27. Higher scores indicate more severe depression or worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Army National Guard members who are scheduled to deploy for OIF/OEF operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary.

Exclusion Criteria:

• Implantable pacemaker or cardiac defibrillator

• Unable to wear a virtual reality headset

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Army National Guard	Blackstone	Virginia	United States	23824

Sponsors and Collaborators

• Biomedical Research Foundation

Investigators

• Principal Investigator: Jeffrey M Pyne, MD, Central Arkansas Veterans Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeffrey Pyne, Research Scientist, Biomedical Research Foundation
• ClinicalTrials.gov Identifier: NCT00838006
• Other Study ID Numbers: PT074626
• First Posted: Feb 6, 2009
• Last Update Posted: Jul 2, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Jeffrey Pyne, Research Scientist, Biomedical Research Foundation: post-traumatic stress disorder; post-deployment; prediction; prevention
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Pre-assignment Detail	426 soldiers were enrolled and completed the pre-deployment assessment. Fo these, 342 were randomized and had at least one follow-up assessment.

Arm/Group Title	Heart Rate Variability Biofeedback Training	Cognitive Bias Modification Training	Control Group
Arm/Group Description	Heart rate variability biofeedback training and iPod with Breath Pacer app heart rate variability biofeedback: Heart rate variability biofeedback,1 session plus handheld device	Cognitive bias modification training and iPod with cognitive bias training app Cognitive bias modification training: Cognitive bias modification training - 1 session plus handheld device	No additional resilience training and iPod with no resilience training apps Sham Comparator: Subjects received iPod without a study app and no additional resilience training
Period Title: Overall Study
STARTED	102	98	142
3-month Post-deployment Follow-up	92	80	135
COMPLETED	68	72	94
NOT COMPLETED	34	26	48

Baseline Characteristics

Arm/Group Title	Cognitive Bias Modification	Heart Rate Variability Biofeedback	Control	Total
Arm/Group Description	Soldiers randomized to Cognitive Bias Modification for Interpretation training arm	Soldiers randomized to Heart Rate Variability Biofeedback training arm	Soldiers randomly assigned to Control group	Total of all reporting groups
Overall Participants	98	102	142	342
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	98 100%	102 100%	142 100%	342 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.0 (8.5)	29.0 (8.6)	28.1 (8.2)	28.7 (8.4)
Sex: Female, Male (Count of Participants)
Female	6 6.1%	16 15.7%	6 4.2%	28 8.2%
Male	92 93.9%	86 84.3%	136 95.8%	314 91.8%
Region of Enrollment (participants) [Number]
United States	98 100%	102 100%	142 100%	342 100%

Outcome Measures

1. Primary Outcome

Title	The PTSD Checklist - Military Version
Description	The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.
Time Frame	pre-deployment, 3-, and 12-months post-deployment

Outcome Measure Data

Analysis Population Description

participants completed baseline and at least one follow-up

Arm/Group Title	HRV Biofeedback	Cognitive Bias Modification Training	Control
Arm/Group Description	Soldiers randomized the heart rate variability biofeedback training arm	Soldiers randomized to the cognitive bias modification for interpretation training arm	Soldiers randomized to the control arm
Measure Participants	102	98	142
Pre-deployment	22.2 (6.6)	23.7 (8.4)	23.8 (9.6)
3-months Post-deployment	25.9 (9.2)	26.5 (11.9)	28.5 (12.7)
12-month Post-deployment	24.5 (9.2)	24.3 (8.6)	23.9 (9.7)

2. Secondary Outcome

Title	Patient Health Questionnaire (PHQ-9)
Description	The PHQ-9 is a nine-item depression module that is based on DSM-IV criteria for major depression. The minimum score is 0 and the maximum score is 27. Higher scores indicate more severe depression or worse outcome.
Time Frame	pre-deployment, 3-, and 12-month post-deployment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Heart Rate Variability Biofeedback Training	Cognitive Bias Modification Training	Control
Arm/Group Description	Soldiers randomized the heart rate variability biofeedback training arm	Soldiers randomized to the Cognitive Bias Modification for Interpretation training arm	Soldiers randomized to the control arm
Measure Participants	102	98	142
Mean (Standard Deviation) [units on a scale]	2.83 (3.19)	3.02 (3.27)	3.03 (3.29)

Adverse Events

Arm/Group Title	HRV Biofeedback		Cognitive Bias Modification Training		Control
Arm/Group Description	Soldiers randomized to heart rate variability biofeedback training arm		Soldiers randomized to Cognitive Bias Modification for Interpretation training arm		Soldiers randomized to the control arm
All Cause Mortality
	HRV Biofeedback		Cognitive Bias Modification Training		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/98 (0%)		0/142 (0%)
Serious Adverse Events
	HRV Biofeedback		Cognitive Bias Modification Training		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/98 (0%)		0/142 (0%)
Other (Not Including Serious) Adverse Events
	HRV Biofeedback		Cognitive Bias Modification Training		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/98 (0%)		0/142 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.