Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cognitive Dysfunction
- Tbi
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized trial with two active comparison interventionsMasking: Triple (Participant, Investigator, Outcomes 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 60 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04109027
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anthony J. W. Chen, MD MA VA Northern California Health Care System, Mather, CA
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