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Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

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ClinicalTrials.gov Identifier: NCT01921179
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Mild Traumatic Brain Injury, Concussion Behavioral: GOALS (Goal-Oriented Attentional Regulation) Behavioral: EDU (Brain Health Education) Not Applicable

Detailed Description:

The overall aim of this proposal is to investigate the potential short and long term effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation (GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with cognitive dysfunction which may lead to functional impairment and poor community reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but also due to deficits in the cognitive control processes.

Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and goal management, and links them to participant-defined real-life goals. In a prior study with individuals with chronic brain injury, this training has improved cognitive performance in areas of complex attention / executive function, memory, complex functional task performance, and daily functioning. Furthermore, functional MRI results after training indicated significantly enhanced modulation of neural processing in extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently completed study with Veterans with a history of chronic TBI also support improvements post GOALS on neuropsychological measures of attention and executive function, performance on complex 'real-life' tasks, and self-report measures of functional performance. Furthermore, participants also showed improvement on the emotional regulation self-report measures. These findings suggest that improving cognitive control may also improve functioning in other domains such as emotional regulation and functional performance in daily life.

In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD, history of mTBI and residual cognitive difficulties will participate in experimental (GOALS), and/or active comparison (Brain Health Education - EDU) interventions matched for time and intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS will have 5 weeks of self-driven practice only. Both groups will participate in pre and post intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6 months. Pre- and post-intervention measurements will include performance on untrained: neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex functional task performance in low structure 'real-world' setting, and self-report measures of emotional regulation and daily functioning.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
Actual Study Start Date : July 31, 2013
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: GOALS (Goal-Oriented Attentional Regulation)
Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.
Behavioral: GOALS (Goal-Oriented Attentional Regulation)
Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.

Active Comparator: EDU (Brain Health Education)
Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
Behavioral: EDU (Brain Health Education)
Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
Other Name: EDU




Primary Outcome Measures :
  1. Performance on neurocognitive measure of attention and executive function post intervention vs control training [ Time Frame: baseline, 5 weeks; 6 month follow-up ]
    Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.


Secondary Outcome Measures :
  1. Performance on untrained complex real-life functional task -Goal Processing Scale post intervention vs control training [ Time Frame: baseline; 5 weeks & 6 month follow-up ]
    Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution.

  2. Performance on self report measures of emotional regulation post intervention vs control training [ Time Frame: baseline, 5 weeks, & 6 month follow-up ]
    Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Score (primary emotional regulation outcome measure)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PTSD
  • History of mild TBI, including concussion > 6 months ago
  • Cognitive difficulties affecting daily functioning
  • Age 18-75
  • Veteran
  • At least 12th grade education or equivalent

Exclusion Criteria:

  • Amnesic/Severe memory problems
  • Active Substance Abuse/Dependence
  • Medical condition that may affect mental status/disrupt study participation
  • Active psychotropic medication changes
  • Participation in evidence-based PTSD treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921179


Locations
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United States, California
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
Martinez, California, United States, 94553
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Tatjana Novakovic-Agopian, PhD San Francisco VA Medical Center, San Francisco, CA

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01921179     History of Changes
Other Study ID Numbers: D1111-I
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following study completion and publication of results we will explore available mechanisms for data sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Post Traumatic Stress Disorder,
Mild Traumatic Brain Injury
Concussion
Cognitive Rehabilitation

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating