Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
Primary Purpose
TBI, Cognitive Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainStrong-GSR
BrainStrong-OPT
Sponsored by

About this trial
This is an interventional treatment trial for TBI focused on measuring attention, working memory, executive functioning
Eligibility Criteria
Inclusion Criteria:
- Post 9/11 Veterans
- age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);
- in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training.
Exclusion Criteria:
- Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training;
- severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains);
- schizophrenia;
- bipolar disorder;
- history of other neurological disorders;
- current medical illnesses that may alter mental status or disrupt participation in the study;
- active psychotropic medication changes;
- symptom magnification or malingering.
Sites / Locations
- VA Northern California Health Care System, Mather, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BrainStrong-GSR
BrainStrong-OPT
Arm Description
Goal-directed State Regulation Training (GSR)
Optimization of Brain Functioning (OPT)
Outcomes
Primary Outcome Measures
Selective Information Processing
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.
Secondary Outcome Measures
Observed Functional performance
The Goal Processing Scale (GPS) measures goal-directed functioning in a complex, ecologically-valid setting. This timed procedure requires participants gather information on three different self-selected activities. Throughout the task, participants are required to follow specific rules and manage unanticipated challenges (e.g., distractions). Evaluators, following a well-specified manual, rate participants' performance across multiple domains of functioning (e.g., maintaining attention in a distracting environment, cognitive flexibility) while they complete the task. The outcome variable of interest will be changes to the GPS total score. GPS scores range from 0 - 10, with higher scores reflecting better goal-directed functioning. Positive change scores will reflect pre-post training improvements to goal-directed functioning, with negative change scores reflecting pre-post worsening of goal-directed functioning.
Progress Towards Goal Attainment
Goal Attainment Scaling (GAS) procedures will be used for setting and measuring progress toward participant goals. GAS is a six-step process to quantify clinically meaningful change. GAS is a highly individualized but quantitative outcome measure. Participants will define goals to complete and identify objective and observable outcomes for each goal, consisting of outcomes both better and worse than anticipated. Participants weigh goals based upon their estimated difficulty level and priority. GAS scores range from -2 to +2, with negative scores indicating participants achieved less than expected, a score of "0" indicating that participants achieved at expectation, and positive scores indicating that participants scored better than expected. The outcome of interest will be the weighted average of each GAS score evaluated post-intervention.
Full Information
NCT ID
NCT04109027
First Posted
September 26, 2019
Last Updated
October 19, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04109027
Brief Title
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
Official Title
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
March 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.
Detailed Description
This project will offer two training approaches targeting difficulties with goal-directed functioning associated with traumatic brain injury. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps - an intervention framework that addresses known barriers to engagement (e.g., convenience and access) and provides tools to intensify training. The study will be open to eligible Veterans (ages 21-60 years old) with history of mild-to-moderate TBI who experience difficulties with cognitive-emotional regulation and goal-directed functioning. After screening for eligibility and providing informed consent, participants will be allocated by permuted block randomization into one of two treatments: Education to optimize brain functioning (OPT), which will teach Veterans about brain health, brain injury and factors that affect brain functioning, or training in goal-directed state regulation skills (GSR), which will teach Veterans skills for regulating cognitive-emotional functioning during goal pursuit. A special emphasis on outreach will be to recruit student Veterans with TBI.
Each intervention will be matched for delivery method, expectation of benefit, workload and attention, and overall duration. Training will last approximately five weeks, accommodating typical academic schedules. Participants will undergo multi-level assessments at baseline (prior to interventions), immediately after training, and at 3 months follow-up, administered in-person by staff at study sites. In order to investigate effects on goal-directed functioning at multiple levels, assessments will include (1) measures of performance on neurocognitive tasks; (2) functional performance on complex, goal-based tasks; (3) ratings of changes in functioning in personal life, and (4) progress toward personal goals as measured with goal attainment scaling procedures. Data will be analyzed to assess immediate and long term changes associated with each intervention; immediate and long-term differences between the interventions; and moderators and mediators of intervention effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI, Cognitive Dysfunction
Keywords
attention, working memory, executive functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial with two active comparison interventions
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Outcomes assessors and investigators will be blinded to study arm. Participants will have equal expectations of learning and benefit from the two active comparisons, though they cannot be blinded to the content of the training interventions. Trainers will have to be aware of the training content.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BrainStrong-GSR
Arm Type
Experimental
Arm Description
Goal-directed State Regulation Training (GSR)
Arm Title
BrainStrong-OPT
Arm Type
Active Comparator
Arm Description
Optimization of Brain Functioning (OPT)
Intervention Type
Behavioral
Intervention Name(s)
BrainStrong-GSR
Other Intervention Name(s)
Goal-directed State Regulation Training (GSR)
Intervention Description
Goal-directed State Regulation Training (GSR)
Intervention Type
Behavioral
Intervention Name(s)
BrainStrong-OPT
Other Intervention Name(s)
Optimization of Brain Functioning (OPT)
Intervention Description
Optimization of Brain Functioning (OPT)
Primary Outcome Measure Information:
Title
Selective Information Processing
Description
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.
Time Frame
Change from baseline to 2 weeks post-intervention
Secondary Outcome Measure Information:
Title
Observed Functional performance
Description
The Goal Processing Scale (GPS) measures goal-directed functioning in a complex, ecologically-valid setting. This timed procedure requires participants gather information on three different self-selected activities. Throughout the task, participants are required to follow specific rules and manage unanticipated challenges (e.g., distractions). Evaluators, following a well-specified manual, rate participants' performance across multiple domains of functioning (e.g., maintaining attention in a distracting environment, cognitive flexibility) while they complete the task. The outcome variable of interest will be changes to the GPS total score. GPS scores range from 0 - 10, with higher scores reflecting better goal-directed functioning. Positive change scores will reflect pre-post training improvements to goal-directed functioning, with negative change scores reflecting pre-post worsening of goal-directed functioning.
Time Frame
2 weeks post-intervention, 3 months post-intervention
Title
Progress Towards Goal Attainment
Description
Goal Attainment Scaling (GAS) procedures will be used for setting and measuring progress toward participant goals. GAS is a six-step process to quantify clinically meaningful change. GAS is a highly individualized but quantitative outcome measure. Participants will define goals to complete and identify objective and observable outcomes for each goal, consisting of outcomes both better and worse than anticipated. Participants weigh goals based upon their estimated difficulty level and priority. GAS scores range from -2 to +2, with negative scores indicating participants achieved less than expected, a score of "0" indicating that participants achieved at expectation, and positive scores indicating that participants scored better than expected. The outcome of interest will be the weighted average of each GAS score evaluated post-intervention.
Time Frame
3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post 9/11 Veterans
age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);
in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training.
Exclusion Criteria:
Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training;
severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains);
schizophrenia;
bipolar disorder;
history of other neurological disorders;
current medical illnesses that may alter mental status or disrupt participation in the study;
active psychotropic medication changes;
symptom magnification or malingering.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanette M Cope
Phone
(916) 843-2893
Email
Jeanette.Cope@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn C Schwenke, PhD MS
Phone
(520) 792-1450
Ext
5447
Email
Dawn.Schwenke@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J. W. Chen, MD MA
Organizational Affiliation
VA Northern California Health Care System, Mather, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655-4200
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jefferson Lee
Phone
(916) 843-2769
Email
Jefferson.Lee2@va.gov
First Name & Middle Initial & Last Name & Degree
Laura L Jones
Phone
(916) 366-5333
Email
Laura.Jones01@va.gov
First Name & Middle Initial & Last Name & Degree
Anthony J. W. Chen, MD MA
12. IPD Sharing Statement
Plan to Share IPD
No
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Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
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