Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2026-05-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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TBI Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial with two active comparison interventions

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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BrainStrong-GSR

Goal-directed State Regulation Training (GSR)

Group Type EXPERIMENTAL

BrainStrong-GSR

Intervention Type BEHAVIORAL

Goal-directed State Regulation Training (GSR)

BrainStrong-OPT

Optimization of Brain Functioning (OPT)

Group Type ACTIVE_COMPARATOR

BrainStrong-OPT

Intervention Type BEHAVIORAL

Optimization of Brain Functioning (OPT)

Interventions

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BrainStrong-GSR

Goal-directed State Regulation Training (GSR)

Intervention Type BEHAVIORAL

BrainStrong-OPT

Optimization of Brain Functioning (OPT)

Intervention Type BEHAVIORAL

Other Intervention Names

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Goal-directed State Regulation Training (GSR) Optimization of Brain Functioning (OPT)

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No