Traumatic Brain InjuryGMTNCT01714531
Improving Outcomes After Traumatic Injury: A Goal Management Approach
A study testing Telephone-Based Goal Management Training in people with Traumatic Brain Injury, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment. The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Telephone-Based Goal Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2016
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Determination of mild TBI using American Congress of Rehabilitation Medicine guidelines;
- No history of schizophrenia, or other psychotic disorder or suicidal intent;
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention;
- Age 21 years or older;
- Able to provide a telephone number and a stable address; and
- Presence of cognitive deficits in executive functioning (defined as 1 SD below the norm referenced mean on any 2 of the following neuropsychological tests, the D-KEF Tower Test, Trails B, and FAS)
Who cannot join
- Having a CT scan showing an intracranial hemorrhage;
- Current alcohol or substance abuse dependence (within the last 6 months);
- Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple sclerosis, Alzheimer's disease);
- Pre-existing cognitive impairment as determined by a validated surrogate or patient questionnaire (defined as a score greater than 3.3 on the IQCODE instrument;
- History of pre-morbid learning disability;and
- Involvement in current litigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Improving Trauma Outcomes: A Goal Management Approach
The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment. The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that can lead to vocational and social disability. Long-term cognitive deficits include problems with memory and attention, and most importantly executive functioning. Depressive and post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The investigators have found that 55% of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival. Executive functioning is defined as "a cognitive domain that controls the execution of complex activities of daily living essential for purposeful, goal directed behaviors." Deficits in executive functioning are the most disabling of all cognitive impairments and affect a person's ability to manage effectively in one's personal and professional life. Current literature shows that deficits in executive functioning contribute to reduced quality of life, difficulty in returning to work, and persistent psychological distress in various medical and surgical populations. Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI. The overall goal of cognitive rehabilitation is not only to improve a person's ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress. Despite evidence supporting the use of cognitive rehabilitation, few studies have systematically addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training (GMT), a structured manual-based intervention targeting executive functions that impact a person's ability to carry out daily tasks. The investigators hypothesize that telephone-based GMT will improve cognitive functioning, functional status, and psychological health in trauma survivors with mild TBI. Emerging research suggests that telephone rehabilitation is a feasible and effective alternative (with much broader applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical. This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning. Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2) telephone-based attention-control; or (3) usual care. Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments, including the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability. Findings from this study will support future research to improve the cognitive, functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods.
- Conditions
- Traumatic Brain Injury
- Being tested
- Telephone-Based Goal Management Training, Telephone-Based Attention-Control
- Keywords
- Mild TBI
- 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.
Telephone-Based Goal Management TrainingBehavioural
Also called GMT
Telephone-Based Attention-ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Telephone-Based Goal Management Training | Experimental | The GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks. Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting. The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks. Receives: Behavioral: Telephone-Based Goal Management Training |
| Telephone-Based Attention-Control | Active comparator | The attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist. The telephone-based attention condition includes 7 sessions delivered over 10 weeks. Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills. Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided Receives: Behavioral: Telephone-Based Attention-Control |
| Usual Care Control | No intervention | Participants in the control group will receive usual care as determined by the treating surgeon. Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-KEFs Tower Test
cognitive test for executive functioning
Measured: 7 months after hospital discharge
Trail Making Test B
Cognitive test for set shifting and cognitive flexibility
Measured: 7 months after hospital discharge
Sustained Attention to Response Test
Cognitive test for failures of sustained attention
Measured: 7 months after hospital discharge
FAS Verbal Fluency Test
Cognitive test for verbal fluency
Measured: 7 months after hospital discharge
Secondary outcomes (2)
Dysexecutive Questionnaire
Self-reported executive functioning
Measured: 7 months after hospital discharge
Functional Activities Questionnaire
Self-reported functional status
Measured: 7 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Kristin Archer, Vanderbilt University Medical Center
- Investigators
- Kristin Archer, PhD, Principal investigator, Vanderbilt School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714531
- Sponsor's protocol ID
- 111484
- Other IDs
- H133G120052
- Acronym
- GMT
- Status last verified
- Apr 2017
- First submitted
- 22 Oct 2012
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Archer KR, Coronado RA, Haislip LR, Abraham CM, Vanston SW, Lazaro AE, Jackson JC, Ely EW, Guillamondegui OD, Obremskey WT. Telephone-based goal management training for adults with mild traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2015 Jun 2;16:244. doi: 10.1186/s13063-015-0775-1.
PubMed 26031289
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Trauma Outcomes: A Goal Management Approach
- ClinicalTrials.gov ID
- NCT01714531
- Acronym / sponsor ID
- GMT / 111484
- Conditions
- Traumatic Brain Injury
- Keywords
- Mild TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Oct 2012 (estimated)
- 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.
The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment. The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that can lead to vocational and social disability. Long-term cognitive deficits include problems with memory and attention, and most importantly executive functioning. Depressive and post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The investigators have found that 55% of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival. Executive functioning is defined as "a cognitive domain that controls the execution of complex activities of daily living essential for purposeful, goal directed behaviors." Deficits in executive functioning are the most disabling of all cognitive impairments and affect a person's ability to manage effectively in one's personal and professional life. Current literature shows that deficits in executive functioning contribute to reduced quality of life, difficulty in returning to work, and persistent psychological distress in various medical and surgical populations. Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI. The overall goal of cognitive rehabilitation is not only to improve a person's ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress. Despite evidence supporting the use of cognitive rehabilitation, few studies have systematically addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training (GMT), a structured manual-based intervention targeting executive functions that impact a person's ability to carry out daily tasks. The investigators hypothesize that telephone-based GMT will improve cognitive functioning, functional status, and psychological health in trauma survivors with mild TBI. Emerging research suggests that telephone rehabilitation is a feasible and effective alternative (with much broader applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical. This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning. Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2) telephone-based attention-control; or (3) usual care. Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments, including the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability. Findings from this study will support future research to improve the cognitive, functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telephone-Based Goal Management Training | Experimental | Behavioral: Telephone-Based Goal Management TrainingThe GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks. Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting. The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks. |
| Telephone-Based Attention-Control | Active comparator | Behavioral: Telephone-Based Attention-ControlThe attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist. The telephone-based attention condition includes 7 sessions delivered over 10 weeks. Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills. Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided |
| Usual Care Control | No intervention | –Participants in the control group will receive usual care as determined by the treating surgeon. Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Determination of mild TBI using American Congress of Rehabilitation Medicine guidelines;
- No history of schizophrenia, or other psychotic disorder or suicidal intent;
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention;
- Age 21 years or older;
- Able to provide a telephone number and a stable address; and
Key exclusion criteria (6 listed)
- Having a CT scan showing an intracranial hemorrhage;
- Current alcohol or substance abuse dependence (within the last 6 months);
- Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple sclerosis, Alzheimer's disease);
- Pre-existing cognitive impairment as determined by a validated surrogate or patient questionnaire (defined as a score greater than 3.3 on the IQCODE instrument;
- History of pre-morbid learning disability;and
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 |
|---|---|---|
| Telephone-Based Goal Management TrainingAlso: GMT | Behavioural | Telephone-Based Goal Management Training |
| Telephone-Based Attention-Control | Behavioural | Telephone-Based Attention-Control |
Primary outcome
D-KEFs Tower Test
Time frame: 7 months after hospital discharge
cognitive test for executive functioning
Trail Making Test B
Time frame: 7 months after hospital discharge
Cognitive test for set shifting and cognitive flexibility
Sustained Attention to Response Test
Time frame: 7 months after hospital discharge
Cognitive test for failures of sustained attention
FAS Verbal Fluency Test
Time frame: 7 months after hospital discharge
Cognitive test for verbal fluency
2 secondary outcomes
Dysexecutive Questionnaire
Time frame: 7 months after hospital discharge
Functional Activities Questionnaire
Time frame: 7 months after hospital discharge
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 Apr 2017.
- Derived from this study: PubMed 26031289Archer KR, Coronado RA, Haislip LR, Abraham CM, Vanston SW, Lazaro AE, Jackson JC, Ely EW, Guillamondegui OD, Obremskey WT. Telephone-based goal management training for adults with mild traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2015 Jun 2;16:244. doi: 10.1186/s13063-015-0775-1.
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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.
Kristin Archer, PhD principal investigator
Vanderbilt School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Based Goal Management Training in people with Traumatic Brain Injury, run by Vanderbilt University Medical Center 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 6 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 24 Apr 2017. 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?
D-KEFs Tower Test (time frame: 7 months after hospital discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714531, which also lists 1 linked publication.
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 Apr 2017.