GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth

NCT04111549 | Completed

• 2 other identifiers: E3073-W1IK2RX003073-01A2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home, which may result in improved daily functioning and increased access to health care for the growing population of aging Veterans with history of TBI. The successful completion of this project may also increase older Veterans' ability to participate in research through increased understanding of the effect of in-home research opportunities on recruitment and retention. Additionally, the evidence gathered from this study may be used in future research studying home-based cognitive rehabilitation treatments for Veterans using telehealth technology.

Conditions

Executive Dysfunction; Brain Injuries, Traumatic

Keywords

Veterans; Rehabilitation; Cognitive training; Telehealth

Outcome Measures

Primary Outcomes (3)

• Overall Attention and Executive Function Change

  Composite of neuropsychological measures of attention and executive function: Letter Number Sequencing; Auditory Consonant Trigrams 9, 18, 36 sec; Digit Vigilance Test -Time \& Errors; Trails B; DKEFS Stroop Inhibition Time \& Errors; DKEFS Stroop Inhibition-Switching Time \& Errors; DKEFS Verbal Fluency Switching; \& DKEFS Design Fluency Switching. All scores will be transformed to z scores using published normative data and then an average will be calculated to obtain the single Overall Attention and Executive Function score. The composite z score will range from -3 to 3, with higher scores indicating better performance.

  Baseline, after 5 week delay repeat baseline, and after 5 week intervention

• Profile of Mood States (POMS) Total Mood Disturbance Change

  Measure of emotion regulation and overall psychological distress. Scores range from 0-200, and higher scores indicate more distress.

  Baseline, after 5 week delay repeat baseline, and after 5 week intervention

• Mayo-Portland Adaptability Inventory Total Score Change

  Post-TBI daily functioning: abilities and participation in daily activities. Scores range from 0-111, with lower scores indicating better function and greater ability and participation.

  Baseline, after 5 week delay repeat baseline, and after 5 week intervention

Study Arms (2)

Home-based telehealth GOALS

EXPERIMENTAL

Participants in this arm will receive the GOALS intervention via in-home video telehealth.

Other: Home-based telehealth GOALS

In-person GOALS

ACTIVE COMPARATOR

Participants in this arm will receive the GOALS intervention in the traditional in-person format.

Other: In-person GOALS

Interventions

Home-based telehealth GOALS OTHER

Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. It will be delivered to aging Veterans with history of TBI via in-home video telehealth.

Home-based telehealth GOALS

In-person GOALS OTHER

Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. It will be delivered to aging Veterans with history of TBI in person.

In-person GOALS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Veterans aged 65 or older with history of chronic TBI (\>6 months post-injury) -- sustained either during military service
• including in combat
• or as a civilian
• Self-reported cognitive complaints \[1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI \[58\]) that interfere(s) with daily function\]
• Endorsement of comfort and familiarity with technology and/or the possession of a personal computer, or other HBT-compatible device
• i.e., tablet, or smartphone
• Per the investigators' preliminary patient survey, approximately 75% of the target population has access to a personal computer
• Participants who do not endorse comfort/familiarity with technology may be eligible to participate if they can identify a family member or other caregiver who is consistently present and willing to assist with connecting to study sessions
• A limited number of VA-issued tablets will be available for use by participants who do not have access to a personal computer or other HBT-compatible device

You may not qualify if:

• Moderate-severe objective cognitive impairment, as measured by score \<20 on the Montreal Cognitive Assessment (MoCA \[59-61\]), that interferes with daily functioning (i.e., Major Neurocognitive Disorder)
• Unstable medical, neurologic, or psychiatric conditions precluding participation in research activities
• Other reasons for being unable or unwilling to participate in study procedures
• Ongoing illicit or prescription drug (Mini International Neuropsychiatric Interview Version 7.0.2 (MINI) \[79\] or alcohol abuse (Alcohol Use Disorders Test-Consumption (AUDIT-C) \[62\]\>8)
• Active psychosis
• Poor English comprehension

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Erica S. Kornblith, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blinded to which condition (in-person or home-based telehealth) a participant completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: After a 5-week delay repeat baseline, participants will be randomized to receive either in-person GOALS or GOALS delivered via home-based video telehealth.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: September 9, 2020
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)