Mild Traumatic Brain InjuryOn-TRACCNCT05315453
Brief Telehealth Cognitive Rehabilitation Following Mild TBI
A study testing Brief Cognitive Rehabilitation in people with Mild Traumatic Brain Injury and Cognitive Impairment, run by University of Washington at 1 site in United States.
Trial summary
In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Cognitive Impairment
- What is being tested?
- Brief Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 13 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+;
- Read, speak, understand English;
- History of at least one mTBI;
- Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral Symptom Inventory items M-P;
- Ability and willingness to participate in audio recorded sessions over video telehealth platform in a private setting, including equipment and internet access;
- Lives within 2 hours of VA Puget Sound or affiliated clinics/University of Washington;
- Will be in Washington State when engaging in treatment sessions
Who cannot join
- Significant cognitive impairment that would limit ability to engage on treatment;
- Neurologic injury or illness that affects cognitive functioning, including history of moderate or severe TBI;
- History of TBI in the past 3 months, from the date of screening;
- History of serious mental illness involving psychotic symptoms;
- Current psychotic or manic symptoms;
- Current or active flag, or documentation in medical record, for behavior or suicide risk;
- Current (within the past 3 months) Substance Use Disorder (not including caffeine or nicotine disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study
In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Among Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration.
Reduced cognitive functioning following mTBI contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. Despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. Even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mTBI and that will be administered over video-based telehealth technology. The development of this intervention was supported by a grant from the Department of Defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mTBI, and also the clinical expertise of the team.
- Conditions
- Mild Traumatic Brain Injury, Cognitive Impairment
- Being tested
- Brief Cognitive Rehabilitation
- Medical subject headings
- Brain Concussion, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive RehabilitationBehavioural
5-session Cognitive Rehabilitation intervention that can be administered over telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Brief Cognitive Rehabilitation | Experimental | 5-session Cognitive Rehabilitation intervention administered over telehealth Receives: Behavioral: Brief Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of administering the On-TRACC intervention to individuals with mTBI
Feasibility measures will include rate of enrollment of eligible individuals as well as dropout rate for enrolled participants. We will also evaluate participant adherence, including proportion of treatment sessions attended and number of days that homework was completed.
Measured: At the completion of 5 week intervention
Secondary outcomes (4)
Participant satisfaction with On-TRACC intervention
Participants will provide feedback on individual treatment sessions and at the end of treatment regarding intervention content. Participants will complete a Weekly Therapy Rating form after each treatment session and an End of Treatment Patient Feedback Form at the end of treatment to provide satisfaction ratings.
Measured: End of each treatment session and at treatment completion, 5 weeks total.
Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms
Pre-post treatment change in post-concussive symptoms (Neurobehavioral Symptom Inventory) will be evaluated.
Measured: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties
Pre-post treatment change in self-reported cognitive difficulties (NeuroQol Item Bank Cognitive Function SF) will be evaluated.
Measured: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Preliminary effectiveness of On-TRACC intervention at improving self-efficacy
Pre-post treatment change in self-efficacy (Cognitive Concerns Self-Efficacy Scale) will be evaluated.
Measured: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start13 Dec 2021
- Primary completion10 Oct 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System
- Responsible party
- Principal investigator, Kathleen Pagulayan, University of Washington
- Investigators
- Kathleen Pagulayan, PhD, Principal investigator, VA Puget Sound Health Care System/University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315453
- Sponsor's protocol ID
- STUDY00013494
- Acronym
- On-TRACC
- Status last verified
- Mar 2023
- First submitted
- 13 Dec 2021
- Last updated
- 24 Mar 2023
- 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT05315453
- Acronym / sponsor ID
- On-TRACC / STUDY00013494
- Conditions
- Mild Traumatic Brain Injury, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 7 Apr 2022 (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.
In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Among Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration.
Reduced cognitive functioning following mTBI contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. Despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. Even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mTBI and that will be administered over video-based telehealth technology. The development of this intervention was supported by a grant from the Department of Defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mTBI, and also the clinical expertise of the team.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Cognitive Rehabilitation | Experimental | Behavioral: Brief Cognitive Rehabilitation5-session Cognitive Rehabilitation intervention administered over telehealth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18+;
- Read, speak, understand English;
- History of at least one mTBI;
- Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral Symptom Inventory items M-P;
- Ability and willingness to participate in audio recorded sessions over video telehealth platform in a private setting, including equipment and internet access;
Key exclusion criteria (7 listed)
- Significant cognitive impairment that would limit ability to engage on treatment;
- Neurologic injury or illness that affects cognitive functioning, including history of moderate or severe TBI;
- History of TBI in the past 3 months, from the date of screening;
- History of serious mental illness involving psychotic symptoms;
- Current psychotic or manic symptoms;
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 |
|---|---|---|
| Brief Cognitive Rehabilitation5-session Cognitive Rehabilitation intervention that can be administered over telehealth. | Behavioural | Brief Cognitive Rehabilitation |
Primary outcome
Feasibility of administering the On-TRACC intervention to individuals with mTBI
Time frame: At the completion of 5 week intervention
Feasibility measures will include rate of enrollment of eligible individuals as well as dropout rate for enrolled participants. We will also evaluate participant adherence, including proportion of treatment sessions attended and number of days that homework was completed.
4 secondary outcomes
Participant satisfaction with On-TRACC intervention
Time frame: End of each treatment session and at treatment completion, 5 weeks total.
Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms
Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties
Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Preliminary effectiveness of On-TRACC intervention at improving self-efficacy
Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
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 24 Mar 2023.
- 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.
Kathleen Pagulayan, PhD principal investigator
VA Puget Sound Health Care System/University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Rehabilitation in people with Mild Traumatic Brain Injury and Cognitive Impairment, run by University of Washington 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 7 inclusion and 7 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 24 Mar 2023. 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?
Feasibility of administering the On-TRACC intervention to individuals with mTBI (time frame: At the completion of 5 week intervention). 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 24 Mar 2023.