Brain ConcussionNCT00857207
Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
A study testing Goal Management Training in people with Brain Concussion and Blast Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches strategies to improve an individual's ability to complete everyday tasks. This research study will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF Veterans receiving a Brain Health… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Brain Concussion, Blast Injuries
- What is being tested?
- Goal Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 2 incidences of blast-related mTBI according to the American Congress of Rehabilitation Medicine, any of three following criteria:
- loss of consciousness <30 minutes, a Glasgow Coma Scale of 13
- loss of memory for events immediately before and after the event (24 hours alteration of mental state at the time of accident)
- focal neurological deficits that may, or may not, be transient (ACRM, 1993)
- Diagnosis must be documented in the medical record by a physician or neuropsychologist.
- Frontal Lobe impairment will be determined by 1.5 standard deviations below the mean on either the D-KEFS Color Word Interference Testorthe EXAMINER composite score.
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- Age 18 to 55 years.
- At least 6 months post injury.
- Family member or friend that is willing to answer questionnaires and provide feedback on questionnaires and completion of homework.
Who cannot join
- History of pre-morbid learning disability.
- History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
- Neurological disease unrelated to TBI (seizure disorder, stroke, ADHD).
- Score < 90 on National Adult Reading Test.
- Failure of validity testing on the Test of Memory Malingering (TOMM)
- Reported alcohol or substance abuse within the past year, or such abuse documented in medical record.
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- Reported involvement in current litigation.
- Changes within the past month of medications known to affect cognitive functions e.g. benzodiazepines, opioids, antidepressants and antipsychotics.
- Currently enrolled in other cognitive therapy that cannot be discontinued.
- Not fluent in English.
- Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
- Patients who receive > 5 hours of therapy from a mental health specialist during the study will not be included in the final analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Official title: Metacognitive Training to Enhance Strategy Use in Blast Related TBI
Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches strategies to improve an individual's ability to complete everyday tasks. This research study will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF Veterans receiving a Brain Health Workshop. The results will provide information to conduct future research with a larger group of patients or to identify which patients demonstrate more benefit from the training.
Read the detailed description
OBJECTIVES:
Aim 1: is to test benefits of GMT for improving executive function. Aim 2: Investigate factors which affect response to treatment.
RESEARCH PLAN:
This is a randomized controlled study to investigate the effect of Goal Management Training (GMT) for those with blast-related mTBI. The control group will participate in the Brain Health Workshop (BHW; Levine 2011), developed specifically for consistency with GMT session length and contact with the facilitator (Levine, 2011). Study outcome measures will be collected at pre- and post-treatment, and at 1 month after the end of treatment.
Family Member/Friend of Participant. The participant will identify a friend or family member who observes his/her everyday behavior at least 2-3 hours, twice a week. After obtaining the consent of the person, both the participant and his/her friend or family member(s) will attend a general education session about brain function and treatments. In addition to attending the education session the consenting friend or family member will answer a questionnaire (BRIEF-A) about the participant's executive function. The friend or family member will also receive phone calls weekly in order to report the participant's ease or difficulties in completing homework.
METHODS:
The investigators will enroll 54 participants, recruited from the North Florida/South Georgia Veteran Health System in Gainesville. Clinical staff will inform outpatients about the study. Patients interested in hearing more about the research study will be provided with contact information for the study staff. A meeting will be scheduled and candidates will be screened.
Participants will be randomly assigned to either treatment or control groups, in a ratio of 38:16. In addition, the Pocock-Simon covariate adaptive randomization procedure will be used so that, for each PTSD severity category within each of the two sites, approximately 70% (38/54) of subjects are assigned to treatment group; consequently, there will be approximately equal proportion of PTSD subjects assigned to the treatment and control groups within each of the two study sites.
Simulated Practice In The Laboratory: Training tasks include exercises such as: 1) clapping to words and inhibiting clapping to a targeted word; 2) card sorting; 3) decision making and planning in order to complete five activities within a four minute time span; 4) Catalog Task; and 5) Book keeping task. Initially, the exercises are relatively easy and subsequently progress to greater complexity. Participant's strengths and weaknesses are discussed. Improvements are identified and reinforced as they learn more efficient planning and problem solving. The following steps are taught during simulated tasks: 1) Identify Main Goal; 2) Break down task into sub-goals and steps for each goal; 3) List supplies needed; 4) Recognize potential barriers to completing goal; 5) Determine strategy to accomplish task: 6) Prepare to begin task with "presence of mind" exercise; 7) State goal out loud; 8) Begin task and stop self frequently to state main goal out loud and check to be sure one is working toward the goal (on target).
Functional Practice at Home and with Smartphone Technology: In addition to lab practice, the original GMT (Levine, 2000)includes three tasks that must be practiced at home. Participants identify a complex task with which they are having difficulty, for example, meal planning and shopping; planning a party; building a birdhouse; or paying monthly bills. Generalization of laboratory practice to home environment is of critical importance. Unfortunately, the original GMT did not provide a method to monitor the frequency or success of home practice, nor a method to support productive practice in the home environment. In prior work, the investigators developed The Veteran's Task Manager (A Smartphone application (AP). Participants will use the AP features to break down tasks, estimate time to complete, check off each step as completed, respond to the visual/vibrating alert of "Goal" and respond to alert if "On Target". Information will be collected by the AP, such as accuracy of planned steps, time to complete task, and number of distractions from goal. The AP will record the participant's performance in functional practice at home and this information will be reviewed at the next lab session.
Control Group Intervention. The Brain Health Workshop (BHW; Levine 2011) was developed specifically for consistency with GMT session length and contact with the facilitator (Levine, 2011). BHW is an education presentation on brain function and cognitive principles of learning. Information about stress reduction, sleep hygiene, energy management, exercise and communication are covered with homework and quizzes on information covered.
FINDINGS: Initial report
- Conditions
- Brain Concussion, Blast Injuries
- Being tested
- Goal Management Training
- Keywords
- Cognitive Therapy, Outcomes Assessment
- Medical subject headings
- Brain Concussion, Blast Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingBehavioural
Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Treatment Goal Management Training | Experimental | Treatment Goal Management Training Receives: Behavioral: Goal Management Training |
| Arm 2: Control-Brain Health Workshop | No intervention | Control-Brain Health Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Tower Of London (cTOL)
a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. The dependent variables are the total time spent solving the problem (0-60 seconds for each problem; less time is better) and the proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome) and time to first move (0-60 seconds with more planning time indicating better outcome).
Measured: Baseline, 10 weeks
Secondary outcomes (2)
BRIEF-A
Behavior Rating Inventory of Executive Functions-Adult (BRIEF-A) is a self and informant report questionnaire consisting of 75 statements about executive behaviors. There are three possible responses to items: often, sometimes, never. Two subscale scores behavioral regulation index and metacognitive index are reported as T-scores adjusted for age with a possible score of 0-100. Lower scores are better indicating less trouble with executive function.
Measured: Baseline, 10 weeks
cTOL Optimal Moves
computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. Optimal moves are a proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome).
Measured: baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study start1 Oct 2013
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies 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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julia K. Waid-Ebbs, PhD, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857207
- Sponsor's protocol ID
- B0902-W
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2009
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waid-Ebbs JK; BCBA-D; Daly J, Wu SS, Berg WK, Bauer RM, Perlstein WM, Crosson B. Response to goal management training in veterans with blast-related mild traumatic brain injury. J Rehabil Res Dev. 2014;51(10):1555-66. doi: 10.1682/JRRD.2013.12.0266.
PubMed 25860148
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Training to Enhance Strategy Use in Blast Related TBI
- ClinicalTrials.gov ID
- NCT00857207
- Acronym / sponsor ID
- B0902-W
- Conditions
- Brain Concussion, Blast Injuries
- Keywords
- Cognitive Therapy, Outcomes Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches strategies to improve an individual's ability to complete everyday tasks. This research study will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF Veterans receiving a Brain Health Workshop. The results will provide information to conduct future research with a larger group of patients or to identify which patients demonstrate more benefit from the training.
Detailed description
OBJECTIVES:
Aim 1: is to test benefits of GMT for improving executive function. Aim 2: Investigate factors which affect response to treatment.
RESEARCH PLAN:
This is a randomized controlled study to investigate the effect of Goal Management Training (GMT) for those with blast-related mTBI. The control group will participate in the Brain Health Workshop (BHW; Levine 2011), developed specifically for consistency with GMT session length and contact with the facilitator (Levine, 2011). Study outcome measures will be collected at pre- and post-treatment, and at 1 month after the end of treatment.
Family Member/Friend of Participant. The participant will identify a friend or family member who observes his/her everyday behavior at least 2-3 hours, twice a week. After obtaining the consent of the person, both the participant and his/her friend or family member(s) will attend a general education session about brain function and treatments. In addition to attending the education session the consenting friend or family member will answer a questionnaire (BRIEF-A) about the participant's executive function. The friend or family member will also receive phone calls weekly in order to report the participant's ease or difficulties in completing homework.
METHODS:
The investigators will enroll 54 participants, recruited from the North Florida/South Georgia Veteran Health System in Gainesville. Clinical staff will inform outpatients about the study. Patients interested in hearing more about the research study will be provided with contact information for the study staff. A meeting will be scheduled and candidates will be screened.
Participants will be randomly assigned to either treatment or control groups, in a ratio of 38:16. In addition, the Pocock-Simon covariate adaptive randomization procedure will be used so that, for each PTSD severity category within each of the two sites, approximately 70% (38/54) of subjects are assigned to treatment group; consequently, there will be approximately equal proportion of PTSD subjects assigned to the treatment and control groups within each of the two study sites.
Simulated Practice In The Laboratory: Training tasks include exercises such as: 1) clapping to words and inhibiting clapping to a targeted word; 2) card sorting; 3) decision making and planning in order to complete five activities within a four minute time span; 4) Catalog Task; and 5) Book keeping task. Initially, the exercises are relatively easy and subsequently progress to greater complexity. Participant's strengths and weaknesses are discussed. Improvements are identified and reinforced as they learn more efficient planning and problem solving. The following steps are taught during simulated tasks: 1) Identify Main Goal; 2) Break down task into sub-goals and steps for each goal; 3) List supplies needed; 4) Recognize potential barriers to completing goal; 5) Determine strategy to accomplish task: 6) Prepare to begin task with "presence of mind" exercise; 7) State goal out loud; 8) Begin task and stop self frequently to state main goal out loud and check to be sure one is working toward the goal (on target).
Functional Practice at Home and with Smartphone Technology: In addition to lab practice, the original GMT (Levine, 2000)includes three tasks that must be practiced at home. Participants identify a complex task with which they are having difficulty, for example, meal planning and shopping; planning a party; building a birdhouse; or paying monthly bills. Generalization of laboratory practice to home environment is of critical importance. Unfortunately, the original GMT did not provide a method to monitor the frequency or success of home practice, nor a method to support productive practice in the home environment. In prior work, the investigators developed The Veteran's Task Manager (A Smartphone application (AP). Participants will use the AP features to break down tasks, estimate time to complete, check off each step as completed, respond to the visual/vibrating alert of "Goal" and respond to alert if "On Target". Information will be collected by the AP, such as accuracy of planned steps, time to complete task, and number of distractions from goal. The AP will record the participant's performance in functional practice at home and this information will be reviewed at the next lab session.
Control Group Intervention. The Brain Health Workshop (BHW; Levine 2011) was developed specifically for consistency with GMT session length and contact with the facilitator (Levine, 2011). BHW is an education presentation on brain function and cognitive principles of learning. Information about stress reduction, sleep hygiene, energy management, exercise and communication are covered with homework and quizzes on information covered.
FINDINGS: Initial report
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Treatment Goal Management Training | Experimental | Behavioral: Goal Management TrainingTreatment Goal Management Training |
| Arm 2: Control-Brain Health Workshop | No intervention | –Control-Brain Health Workshop |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 2 incidences of blast-related mTBI according to the American Congress of Rehabilitation Medicine, any of three following criteria:
- Diagnosis must be documented in the medical record by a physician or neuropsychologist.
- Frontal Lobe impairment will be determined by 1.5 standard deviations below the mean on either the D-KEFS Color Word Interference Testorthe EXAMINER composite score.
- Age 18 to 55 years.
- At least 6 months post injury.
Key exclusion criteria (12 listed)
- History of pre-morbid learning disability.
- History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
- Neurological disease unrelated to TBI (seizure disorder, stroke, ADHD).
- Score < 90 on National Adult Reading Test.
- Failure of validity testing on the Test of Memory Malingering (TOMM)
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 |
|---|---|---|
| Goal Management TrainingEnhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks. | Behavioural | Arm 1: Treatment Goal Management Training |
Primary outcome
Computerized Tower Of London (cTOL)
Time frame: Baseline, 10 weeks
a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. The dependent variables are the total time spent solving the problem (0-60 seconds for each problem; less time is better) and the proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome) and time to first move (0-60 seconds with more planning time indicating better outcome).
2 secondary outcomes
BRIEF-A
Time frame: Baseline, 10 weeks
cTOL Optimal Moves
Time frame: baseline, 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25860148Waid-Ebbs JK; BCBA-D; Daly J, Wu SS, Berg WK, Bauer RM, Perlstein WM, Crosson B. Response to goal management training in veterans with blast-related mild traumatic brain injury. J Rehabil Res Dev. 2014;51(10):1555-66. doi: 10.1682/JRRD.2013.12.0266.
- 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.
Julia K. Waid-Ebbs, PhD principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training in people with Brain Concussion and Blast Injuries, 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 12 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 30 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Computerized Tower Of London (cTOL) (time frame: Baseline, 10 weeks). 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 NCT00857207, 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 30 Mar 2021.