Clinical trial NCT04109027: 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
Overall status: RECRUITING
Phase: NA
Conditions: TBI
Cognitive Dysfunction
Keywords: attention
working memory
executive functioning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial with two active comparison interventions
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Selective Information Processing
timeFrame: Change from baseline to 2 weeks post-intervention
Secondary outcomes:
measure: Observed Functional performance
timeFrame: 2 weeks post-intervention, 3 months post-intervention
measure: Progress Towards Goal Attainment
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
Study officials:
affiliation: VA Northern California Health Care System, Mather, CA
name: Anthony J. W. Chen, MD MA
role: PRINCIPAL_INVESTIGATOR
References: