Traumatic Brain InjuryNCT00233129
Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program
A study testing Top Down and cognitive rehabilitation day treatment program in people with Traumatic Brain Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the "Executive Plus" program; the latter emphasizes training of attention, emotional self-regulation and problem solving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Top Down and cognitive rehabilitation day treatment program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2010
- 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
- At least 18 years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury).
- At least three months post-injury
- English-speaking (treatment sessions will be conducted in English)
- Reporting executive dysfunction (by self or family)
- Willing and able to participate in and travel to the program daily for six months
Show all 13Show fewer
- Oriented to time, place and person
- Having a full-scale intelligence quotient (IQ) of at least 75
- Having a score on the Galveston Orientation and Amnesia Test of 75 or more
- Having communication skills adequate to participate in groups
- Having at least a sixth-grade reading level (for testing and use of written materials)
- Willing to complete questionnaires and interviews about mood, thinking skills, participation and the like
- Agree to participate, i.e., completion of informed consent and Health Insurance Portability and Accountability Act (HIPAA) documents
Who cannot join
- Active substance abuse
- Active psychosis
- Active suicidality
- Disruptive or violent behavior to self or others
- Current cognitive rehabilitation (this does not include psychotherapy)
- No impairment on the Frontal Systems Behavior Scale (FRSBE) or Wisconsin Card Sorting Test (WCST)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
About this study
Official title: Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program
This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the "Executive Plus" program; the latter emphasizes training of attention, emotional self-regulation and problem solving. The goal of the Executive Plus program is to maximize executive functioning, as well as the long-term outcomes of community participation and satisfaction with daily life.
Read the detailed description
This is a randomized clinical trial comparing two approaches to post-TBI comprehensive day treatment. Executive Plus offers systematic treatment of post-TBI executive function deficits, through a focus on problem solving and emotional self-regulation, as well as systematic treatment of post-TBI attention deficits. It relies on modular, contextual, and embedded approaches to treatment. It will be compared to Mount Sinai's currently operating day treatment program. The 26-week programs will run concurrently and potential participants will be randomly assigned to Executive Plus or the standard program, using rolling admissions. Program staffs will be separate. Outcomes will be assessed using measures that focus on functioning within cognitive domains, across domains and in everyday life, and that assess long-term outcomes. Detailed manuals will be developed to guide the implementation of each program's operation.
- Conditions
- Traumatic Brain Injury
- Being tested
- Top Down, cognitive rehabilitation day treatment program
- Keywords
- Day treatment, executive function, problem solving, attention, participation, TBI, brain injury, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Top DownBehavioural
Also called Executive Plus Day Treatment Program
Six months
cognitive rehabilitation day treatment programOther
six months
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | cognitive rehabilitation day treatment program Receives: Other: cognitive rehabilitation day treatment program |
| Top-Down | Experimental | cognitive rehabilitation day treatment program that incorporates systematic "top down" treatment of executive function deficits (problem solving and emotional regulation training), systematic treatment of attention deficits, and modular, contextual and embedded approaches to treatment. Receives: Behavioral: Top Down |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Measured: At baseline
Cognitive function
Measured: 5 weeks into treatment
Cognitive function
Measured: At treatment end (6 months after baseline)
Cognitive function
Measured: 6 months after completing treatment
Cognitive function
Measured: 12 months after completing treatment
Secondary outcomes (25)
Memory
Measured: At baseline
Memory
Measured: 5 weeks into treatment
Memory
Measured: At treatment end (6 months after baseline)
Memory
Measured: 6 months after completing treatment
Memory
Measured: 12 months after completing treatment
Learning
Measured: At baseline
Learning
Measured: 5 weeks into treatment
Learning
Measured: At treatment end (6 months after baseline)
Learning
Measured: 6 months after completing treatment
Learning
Measured: 12 months after completing treatment
Participation
Measured: At baseline
Participation
Measured: 5 weeks into treatment
Participation
Measured: At treatment end (6 months after baseline)
Participation
Measured: 6 months after completing treatment
Participation
Measured: 12 months after completing treatment
Affective distress
Measured: At baseline
Affective distress
Measured: 5 weeks into treatment
Affective distress
Measured: At treatment end (6 months after baseline)
Affective distress
Measured: 6 months after completing treatment
Affective distress
Measured: 12 months after completing treatment
Life satisfaction and self-efficacy
Measured: At baseline
Life satisfaction and self-efficacy
Measured: 5 weeks into treatment
Life satisfaction and self-efficacy
Measured: At treatment end (6 months after baseline)
Life satisfaction and self-efficacy
Measured: 6 months after completing treatment
Life satisfaction and self-efficacy
Measured: 12 months after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Wayne A Gordon, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233129
- Sponsor's protocol ID
- GCO# 04-0782
- Other IDs
- #H133B040033
- Status last verified
- Sep 2013
- First submitted
- 3 Oct 2005
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program
- ClinicalTrials.gov ID
- NCT00233129
- Acronym / sponsor ID
- GCO# 04-0782
- Conditions
- Traumatic Brain Injury
- Keywords
- Day treatment, executive function, problem solving, attention, participation, TBI, brain injury, traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Oct 2005 (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.
This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the "Executive Plus" program; the latter emphasizes training of attention, emotional self-regulation and problem solving. The goal of the Executive Plus program is to maximize executive functioning, as well as the long-term outcomes of community participation and satisfaction with daily life.
Detailed description
This is a randomized clinical trial comparing two approaches to post-TBI comprehensive day treatment. Executive Plus offers systematic treatment of post-TBI executive function deficits, through a focus on problem solving and emotional self-regulation, as well as systematic treatment of post-TBI attention deficits. It relies on modular, contextual, and embedded approaches to treatment. It will be compared to Mount Sinai's currently operating day treatment program. The 26-week programs will run concurrently and potential participants will be randomly assigned to Executive Plus or the standard program, using rolling admissions. Program staffs will be separate. Outcomes will be assessed using measures that focus on functioning within cognitive domains, across domains and in everyday life, and that assess long-term outcomes. Detailed manuals will be developed to guide the implementation of each program's operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Other: cognitive rehabilitation day treatment programcognitive rehabilitation day treatment program |
| Top-Down | Experimental | Behavioral: Top Downcognitive rehabilitation day treatment program that incorporates systematic "top down" treatment of executive function deficits (problem solving and emotional regulation training), systematic treatment of attention deficits, and modular, contextual and embedded approaches to treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury).
- At least three months post-injury
- English-speaking (treatment sessions will be conducted in English)
- Reporting executive dysfunction (by self or family)
Key exclusion criteria (6 listed)
- Active substance abuse
- Active psychosis
- Active suicidality
- Disruptive or violent behavior to self or others
- Current cognitive rehabilitation (this does not include psychotherapy)
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 |
|---|---|---|
| Top DownAlso: Executive Plus Day Treatment ProgramSix months | Behavioural | Top-Down |
| cognitive rehabilitation day treatment programsix months | Other | Standard Treatment |
Primary outcome
Cognitive function
Time frame: At baseline
Cognitive function
Time frame: 5 weeks into treatment
Cognitive function
Time frame: At treatment end (6 months after baseline)
Cognitive function
Time frame: 6 months after completing treatment
Cognitive function
Time frame: 12 months after completing treatment
25 secondary outcomes
Memory
Time frame: At baseline
Memory
Time frame: 5 weeks into treatment
Memory
Time frame: At treatment end (6 months after baseline)
Memory
Time frame: 6 months after completing treatment
Memory
Time frame: 12 months after completing treatment
Learning
Time frame: At baseline
Learning
Time frame: 5 weeks into treatment
Learning
Time frame: At treatment end (6 months after baseline)
Learning
Time frame: 6 months after completing treatment
Learning
Time frame: 12 months after completing treatment
Participation
Time frame: At baseline
Participation
Time frame: 5 weeks into treatment
Participation
Time frame: At treatment end (6 months after baseline)
Participation
Time frame: 6 months after completing treatment
Participation
Time frame: 12 months after completing treatment
Affective distress
Time frame: At baseline
Affective distress
Time frame: 5 weeks into treatment
Affective distress
Time frame: At treatment end (6 months after baseline)
Affective distress
Time frame: 6 months after completing treatment
Affective distress
Time frame: 12 months after completing treatment
Life satisfaction and self-efficacy
Time frame: At baseline
Life satisfaction and self-efficacy
Time frame: 5 weeks into treatment
Life satisfaction and self-efficacy
Time frame: At treatment end (6 months after baseline)
Life satisfaction and self-efficacy
Time frame: 6 months after completing treatment
Life satisfaction and self-efficacy
Time frame: 12 months after completing treatment
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 Sep 2013.
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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.
Wayne A Gordon, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Top Down and cognitive rehabilitation day treatment program in people with Traumatic Brain Injury, run by Icahn School of Medicine at Mount Sinai 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 13 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 Sep 2013. 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?
Cognitive function (time frame: At baseline). The study lists 5 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 24 Sep 2013.