Brain Injuries, TraumaticTeleGOALSNCT04111549
GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth
A study testing Home-based telehealth GOALS and In-person GOALS in people with Brain Injuries, Traumatic and Executive Dysfunction, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Brain Injuries, Traumatic, Executive Dysfunction
- What is being tested?
- Home-based telehealth GOALS and In-person GOALS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
About this study
Official title: Rehabilitation of Executive Function in Aging Veterans With History of TBI
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.
Read the detailed description
The goal of this project is to investigate the feasibility and acceptability of using technology to implement home-based executive function training for aging Veterans with history of traumatic brain injury (TBI).
Background: Problems with attention and executive control are some of the most common sequelae of TBI, and these areas of cognition are also known to be vulnerable to aging. 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.
Relevance and significance to Veteran's health: TBI is prevalent among Veterans. Home-based telehealth (HBT) may be an effective tool to address lack of access to health care for aging Veterans.
Aim 1: Complete adaptation of the IP-GOALS protocol for a) HBT use and b) use with older Veterans via collection of feedback from [n=8] Veterans 65+ with history of TBI and cognitive complaints. Aim 2: Examine the feasibility (defined as recruitment yield, dropout after randomization, retention, and adherence) and participant-rated acceptability of [IP and] HBT-GOALS in n=36 Veterans 65+ with history of TBI and cognitive complaints. Hypothesis 2: Feasibility will be demonstrated by achieving targeted recruitment goals with reasonable rates of dropout after randomization, retention, and adherence, and high levels of participant-rated acceptability in both groups. Aim 3: Estimate effect sizes for [HBT-GOALS and IP-GOALS using a double-baseline control] on improving a) cognitive performance and self-reported b) emotional regulation and c) daily functioning in the same Aim 2 study cohort to inform sample size requirements for a future clinical trial. Hypothesis 3: Effect size estimates will provide evidence of clinically meaningful improvement on a) cognitive functioning (Attention and Executive Function Composite), b) emotional regulation (Profile of Mood States Total Mood Disturbance Score), and c) daily functioning outcomes (Mayo-Portland Adaptability Inventory Total Score). Exploratory analysis a) will examine whether Veteran characteristics (e.g., age, sex, family/caregiver support, distance to nearest clinic, and health/mobility issues including chronic pain) are associated with differences in participant-rated acceptability and feasibility (i.e., recruitment yield, dropout after randomization, retention and adherence), and [response to IP/HBT-GOALS vs. double baseline control.] Exploratory analysis b) will examine distribution of responses to select criteria to define responders in future studies.
Methods: Adaptation phase (Aim 1): Adaptation of the existing GOALS protocol for a) HBT use and b) use with older Veterans will be completed by collecting post-training feasibility and acceptability data. Pilot phase (Aims 2 and 3 and Exploratory Analyses): Feasibility, acceptability, cognitive, emotional, and daily functioning data will be collected from n=36 Veterans 65 or older before (baseline and delay baseline) and after participation in GOALS training delivered in person (IP) or via HBT. Veterans will be randomly assigned to IP or HBT. Outcome measures include participant-rated acceptability; feasibility (i.e., recruitment yield, dropout after randomization, retention, and adherence); standardized and validated measures of neurocognitive functioning; self-report of symptoms of depression, PTSD, mood disturbance, and daily functioning.
Innovation: The proposed study is the first to investigate implementation of an established cognitive rehabilitation intervention for use with aging Veterans with history of TBI and delivery via in-home videoconferencing technology.
Implications: This research may promote improved daily functioning for aging Veterans with history of TBI through rehabilitation of executive function, and increase access to such treatment.
- Conditions
- Brain Injuries, Traumatic, Executive Dysfunction
- Being tested
- Home-based telehealth GOALS, In-person GOALS
- Keywords
- Veterans, Rehabilitation, Cognitive training, Telehealth
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based telehealth GOALSOther
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.
In-person GOALSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based telehealth GOALS | Experimental | Participants in this arm will receive the GOALS intervention via in-home video telehealth. Receives: 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. Receives: Other: In-person GOALS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, after 5 week delay repeat baseline, and after 5 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start9 Sep 2020
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erica S. Kornblith, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111549
- Sponsor's protocol ID
- E3073-W
- Other IDs
- 1IK2RX003073-01A2
- Acronym
- TeleGOALS
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Executive Function in Aging Veterans With History of TBI
- ClinicalTrials.gov ID
- NCT04111549
- Acronym / sponsor ID
- TeleGOALS / E3073-W
- Conditions
- Brain Injuries, Traumatic, Executive Dysfunction
- Keywords
- Veterans, Rehabilitation, Cognitive training, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this project is to investigate the feasibility and acceptability of using technology to implement home-based executive function training for aging Veterans with history of traumatic brain injury (TBI).
Background: Problems with attention and executive control are some of the most common sequelae of TBI, and these areas of cognition are also known to be vulnerable to aging. 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.
Relevance and significance to Veteran's health: TBI is prevalent among Veterans. Home-based telehealth (HBT) may be an effective tool to address lack of access to health care for aging Veterans.
Aim 1: Complete adaptation of the IP-GOALS protocol for a) HBT use and b) use with older Veterans via collection of feedback from [n=8] Veterans 65+ with history of TBI and cognitive complaints. Aim 2: Examine the feasibility (defined as recruitment yield, dropout after randomization, retention, and adherence) and participant-rated acceptability of [IP and] HBT-GOALS in n=36 Veterans 65+ with history of TBI and cognitive complaints. Hypothesis 2: Feasibility will be demonstrated by achieving targeted recruitment goals with reasonable rates of dropout after randomization, retention, and adherence, and high levels of participant-rated acceptability in both groups. Aim 3: Estimate effect sizes for [HBT-GOALS and IP-GOALS using a double-baseline control] on improving a) cognitive performance and self-reported b) emotional regulation and c) daily functioning in the same Aim 2 study cohort to inform sample size requirements for a future clinical trial. Hypothesis 3: Effect size estimates will provide evidence of clinically meaningful improvement on a) cognitive functioning (Attention and Executive Function Composite), b) emotional regulation (Profile of Mood States Total Mood Disturbance Score), and c) daily functioning outcomes (Mayo-Portland Adaptability Inventory Total Score). Exploratory analysis a) will examine whether Veteran characteristics (e.g., age, sex, family/caregiver support, distance to nearest clinic, and health/mobility issues including chronic pain) are associated with differences in participant-rated acceptability and feasibility (i.e., recruitment yield, dropout after randomization, retention and adherence), and [response to IP/HBT-GOALS vs. double baseline control.] Exploratory analysis b) will examine distribution of responses to select criteria to define responders in future studies.
Methods: Adaptation phase (Aim 1): Adaptation of the existing GOALS protocol for a) HBT use and b) use with older Veterans will be completed by collecting post-training feasibility and acceptability data. Pilot phase (Aims 2 and 3 and Exploratory Analyses): Feasibility, acceptability, cognitive, emotional, and daily functioning data will be collected from n=36 Veterans 65 or older before (baseline and delay baseline) and after participation in GOALS training delivered in person (IP) or via HBT. Veterans will be randomly assigned to IP or HBT. Outcome measures include participant-rated acceptability; feasibility (i.e., recruitment yield, dropout after randomization, retention, and adherence); standardized and validated measures of neurocognitive functioning; self-report of symptoms of depression, PTSD, mood disturbance, and daily functioning.
Innovation: The proposed study is the first to investigate implementation of an established cognitive rehabilitation intervention for use with aging Veterans with history of TBI and delivery via in-home videoconferencing technology.
Implications: This research may promote improved daily functioning for aging Veterans with history of TBI through rehabilitation of executive function, and increase access to such treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-based telehealth GOALS | Experimental | Other: Home-based telehealth GOALSParticipants in this arm will receive the GOALS intervention via in-home video telehealth. |
| In-person GOALS | Active comparator | Other: In-person GOALSParticipants in this arm will receive the GOALS intervention in the traditional in-person format. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Veterans aged 65 or older with history of chronic TBI (>6 months post-injury) -- sustained either during military service
- 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
- Per the investigators' preliminary patient survey, approximately 75% of the target population has access to a personal computer
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based telehealth GOALSGoal 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. | Other | Home-based telehealth GOALS |
| In-person GOALSGoal 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. | Other | In-person GOALS |
Primary outcome
Overall Attention and Executive Function Change
Time frame: Baseline, after 5 week delay repeat baseline, and after 5 week intervention
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.
Profile of Mood States (POMS) Total Mood Disturbance Change
Time frame: Baseline, after 5 week delay repeat baseline, and after 5 week intervention
Measure of emotion regulation and overall psychological distress. Scores range from 0-200, and higher scores indicate more distress.
Mayo-Portland Adaptability Inventory Total Score Change
Time frame: Baseline, after 5 week delay repeat baseline, and after 5 week intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica S. Kornblith, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based telehealth GOALS and In-person GOALS in people with Brain Injuries, Traumatic and Executive Dysfunction, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Attention and Executive Function Change (time frame: Baseline, after 5 week delay repeat baseline, and after 5 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.