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Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study

Primary Purpose

Post-Traumatic Stress Disorders, Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Cognitive Training
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorders focused on measuring PTSD, TBI, Cognition, Cognitive Training

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Rural residence
  • Willingness to commit to the time requirements of the study
  • Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI)
  • Native English speaker
  • 20-40 years
  • Normal or corrected to normal vision and hearing.

Exclusion Criteria:

  • Substance dependence
  • Major depression with suicidal ideation
  • Psychotic disorder
  • History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment
  • History of known or suspected learning disorder.

Sites / Locations

  • Michael E. DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive training

Control

Arm Description

Cognitive Intervention Tasks Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks. Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily. All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.

The control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.

Outcomes

Primary Outcome Measures

Compliance rates
Compliance is defined as number of times per week and number of hours per day of task performance
Qualitative assessment
Participants' reactions to the study will be gathered with Likert scale ratings of perceived problems of delivery, ease of program use, and perceived improvement of cognition. Open-ended responses to structured questions on likes and dislikes, suggestions for improvement, and overall satisfaction will also be implemented.

Secondary Outcome Measures

Improvement in performance over time
Performance at the beginning of the training session of each task will be compared to performance at the completion of the training session of each task.
Relation of performance to mental health
Scores on pre- and post- mental health measures will also be related to task performance

Full Information

First Posted
January 14, 2011
Last Updated
March 20, 2018
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01278316
Brief Title
Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
Official Title
Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted to understand whether training in tasks that require perceiving and thinking about things, or cognition, can improve memory in veterans who have been exposed to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine whether it is feasible for veterans who don't live close to a VA to perform this cognitive training at home.
Detailed Description
Many military personnel have experienced traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) as a result of the current Afghanistan and Iraq wars. TBI occurs when a sudden force causes the brain to move, causing damage to brain cells. PTSD is an anxiety disorder associated with serious traumatic events. Blast explosions can lead to TBI. People who experience TBI as a result of a blast injury are more likely to experience PTSD than people who have TBI not due to blast. TBI and PTSD may be associated with memory problems in some patients. Because therapy for PTSD sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. It is possible that improving memory may also improve PTSD treatment. This is a prospective study of Operation Enduring Freedom and Operation Iraqi Freedom (Afghanistan and Iraq wars; OEF/OIF) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. This is a feasibility study to ascertain whether OEF/OIF veterans diagnosed with mild TBI and comorbid PTSD and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders, Traumatic Brain Injury
Keywords
PTSD, TBI, Cognition, Cognitive Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive training
Arm Type
Experimental
Arm Description
Cognitive Intervention Tasks Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks. Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily. All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants will be asked to perform computerized tasks that involve auditory and verbal performance one hour each day, five days per week for 8-10 weeks. Six tasks requiring auditory and verbal information will be presented.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks. Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily. All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
Primary Outcome Measure Information:
Title
Compliance rates
Description
Compliance is defined as number of times per week and number of hours per day of task performance
Time Frame
Up to ten weeks
Title
Qualitative assessment
Description
Participants' reactions to the study will be gathered with Likert scale ratings of perceived problems of delivery, ease of program use, and perceived improvement of cognition. Open-ended responses to structured questions on likes and dislikes, suggestions for improvement, and overall satisfaction will also be implemented.
Time Frame
Up to ten weeks
Secondary Outcome Measure Information:
Title
Improvement in performance over time
Description
Performance at the beginning of the training session of each task will be compared to performance at the completion of the training session of each task.
Time Frame
Up to ten weeks
Title
Relation of performance to mental health
Description
Scores on pre- and post- mental health measures will also be related to task performance
Time Frame
At ten weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Rural residence Willingness to commit to the time requirements of the study Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI) Native English speaker 20-40 years Normal or corrected to normal vision and hearing. Exclusion Criteria: Substance dependence Major depression with suicidal ideation Psychotic disorder History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment History of known or suspected learning disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary R Newsome, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study

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