Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

NCT01921179 | Completed Results

• 1 other identifier: D1111-I
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Traumatic Stress Disorder; Mild Traumatic Brain Injury, Concussion

Keywords

Post Traumatic Stress Disorder,; Mild Traumatic Brain Injury; Concussion; Cognitive Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training

  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. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

  baseline, 5 weeks

• Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline

  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. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

  baseline, 6+ months after GOALS training

Secondary Outcomes (4)

• Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training

  baseline; 5 weeks

• Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline

  baseline, 6 months post GOALS training

• Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training

  baseline, 5 weeks

• Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention

  baseline, 6 months

Study Arms (2)

GOALS (Goal-Oriented Attentional Regulation)

EXPERIMENTAL

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)

EDU (Brain Health Education)

ACTIVE COMPARATOR

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)

Interventions

GOALS (Goal-Oriented Attentional Regulation) BEHAVIORAL

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.

GOALS (Goal-Oriented Attentional Regulation)

EDU (Brain Health Education) BEHAVIORAL

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.

Also known as: EDU

EDU (Brain Health Education)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Martinez Outpatient Clinic and Community Living Center, Martinez, CA

Martinez, California, 94553, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (4)

• Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.

  PMID: 21169860 RESULT

• Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.

  PMID: 21515904 RESULT

• Novakovic-Agopian T, Chen AJ, Rome S, Rossi A, Abrams G, D'Esposito M, Turner G, McKim R, Muir J, Hills N, Kennedy C, Garfinkle J, Murphy M, Binder D, Castelli H. Assessment of subcomponents of executive functioning in ecologically valid settings: the goal processing scale. J Head Trauma Rehabil. 2014 Mar-Apr;29(2):136-46. doi: 10.1097/HTR.0b013e3182691b15.

  PMID: 23076096 RESULT

• Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.

  PMID: 29717652 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Limitations and Caveats

One important limitation of this study is a relatively small sample size, which may have also resulted in our interaction analyses being under powered, possibly leading to failure to detect true effects of group on outcomes

Results Point of Contact

• Title: Dr Tatjana Novakovic-Agopian
• Organization: San Francisco VA HCS

tatjana.novakovic-agopian@va.gov

415-753-3888

Study Officials

• Tatjana Novakovic-Agopian, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 13, 2013
• Study Start: July 31, 2013
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)