Traumatic Brain InjurySTEPNCT00627237
Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the "Short Term Executive Plus" Program
A study testing Immediate Start and Waitlist in people with Traumatic Brain Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain injury (TBI). 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?
- Immediate Start and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2013
- 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
- Be 18 years old or older;
- 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);
- Being at least three months post-injury;
- Being English-speaking (treatment sessions will be conducted in English);
- Reporting executive dysfunction (by self or family);
- Being willing and able to participate in and travel to the program daily for three months;
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- Being oriented to time, place and person;
- Having a full-scale 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);
- Being willing to complete questionnaires and interviews about mood, thinking skills, participation and the like; AND
- Agreeing to participate, i.e., completion of informed consent and HIPAA documents.
Who cannot join
- Have diminished mental capacity and as a result, are unable to sign informed consent;
- Active substance abuse;
- Active psychosis;
- Active suicidality;
- Disruptive or violent behavior to self or others;
- Current cognitive rehabilitation (this will not include current psychotherapy);
- No impairment on the FRSBE or WCST; OR
- Showing evidence of or a diagnosis of dementia or mild cognitive impairment.
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: Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation.
The purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain injury (TBI).
Read the detailed description
Executive dysfunction following brain injury (BI) is commonly observed and has been well documented in the literature (Mateer, 1999; Prigatano, 1999; Levine et al., 2000; Shallice \& Burgess, 1991; Cicerone \& Giacino, 1992; Goldman-Rakic, 1993; Lezak, 1995, Riegal \& Gauggel, 2002; McDonald, 2002; Stuss and Levine, 2003). Level of functioning such as vocational success, community reintegration, and social autonomy are associated with executive functioning abilities following BI (Mazaux et al. 1997, Sohlberg, Mateer, \& Stuss, 1993; (Stuss \& Levine, 2002, McDonald, 2002). Studies describing the rehabilitation of executive dysfunction have been limited to mostly single case or small group designs (Cicerone, et al., 2000). However, there have been three small randomized clinical trials that have had promising results suggesting the need for more research in this area. When considering all of the studies, it is evident that emphasis has been placed on three areas of intervention: attention remediation, emotional regulation and problem-solving. Consequently, given the pervasive disability found in individuals with BI that is secondary to executive function disorders and the promising, but limited, success of problem-solving-based interventions for executive functions, a randomized controlled trial (RCT) of the efficacy of a short-term, intensive executive function training program (Short-Term Executive Plus) is proposed. The Short-Term Executive Plus (STEP) program will combine treatments and treatment approaches that have proved to be effective in previous studies and will be compared to "wait-list" control group. This design was chosen because no appropriate control intervention exists. In other words there is no "standard" rehabilitation treatment available to these individuals that could serve as an appropriate "control" condition/treatment. As discussed earlier, cognitive remediation is typically delivered in extended full-time day treatment programs or weekly/bi-weekly individual sessions. Using more traditional extended treatments as a control condition would be inappropriate, as persons who can participate in extended, full-time are not the target of the proposed intervention. It is hypothesized that the STEP program will result in significant improvements in executive functioning (and related areas of attention, memory, community participation, and life satisfaction).
- Conditions
- Traumatic Brain Injury
- Being tested
- Immediate Start, Waitlist
- Keywords
- Brain Injuries, Cognitive Rehabilitation, Executive Functioning
- 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.
Immediate StartBehavioural
Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
WaitlistBehavioural
Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
| Study group | Role | What they receive |
|---|---|---|
| Immediate start | Experimental | Starts the 12 week intervention immediately after enrollment Receives: Behavioral: Immediate Start |
| Waitlist group | Experimental | Starts the 12 week intervention 12 weeks after initial enrollment Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning
Measured: At the beginning of the intervention
Executive functioning
Measured: At 12 weeks
Executive functioning
Measured: At 24 weeks
Executive functioning
Measured: At 6 months
Executive functioning
Measured: At 1 year post-intervention.
Secondary outcomes (20)
Attention
Measured: At the beginning of the intervention
Attention
Measured: At 12 weeks
Attention
Measured: At 24 weeks
Attention
Measured: At 6 months
Attention
Measured: At 1 year post-intervention
Depression and anxiety
Measured: At the beginning of the intervention
Depression and anxiety
Measured: At 12 weeks
Depression and anxiety
Measured: At 24 weeks
Depression and anxiety
Measured: At 6 months
Depression and anxiety
Measured: At 1 year post-intervention
Memory and learning
Measured: At the beginning of the intervention
Memory and learning
Measured: At 12 weeks
Memory and learning
Measured: At 24 weeks
Memory and learning
Measured: At 6 months
Memory and learning
Measured: At 1 year post-intervention
Participation, life satisfaction, and self-efficacy
Measured: At the beginning of the intervention
Participation, life satisfaction, and self-efficacy
Measured: At 12 weeks
Participation, life satisfaction, and self-efficacy
Measured: At 24 weeks
Participation, life satisfaction, and self-efficacy
Measured: At 6 months
Participation, life satisfaction, and self-efficacy
Measured: At 1 year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2012
- Study completionJul 2013
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Wayne Gordon, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627237
- Sponsor's protocol ID
- GCO 06-0939
- Other IDs
- CE001171
- Acronym
- STEP
- Status last verified
- Sep 2013
- First submitted
- 20 Feb 2008
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cantor J, Ashman T, Dams-O'Connor K, Dijkers MP, Gordon W, Spielman L, Tsaousides T, Allen H, Nguyen M, Oswald J. Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil. 2014 Jan;95(1):1-9.e3. doi: 10.1016/j.apmr.2013.08.005. Epub 2013 Aug 27.
PubMed 23988395
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
- Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation.
- ClinicalTrials.gov ID
- NCT00627237
- Acronym / sponsor ID
- STEP / GCO 06-0939
- Conditions
- Traumatic Brain Injury
- Keywords
- Brain Injuries, Cognitive Rehabilitation, Executive Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Feb 2008 (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 purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain injury (TBI).
Detailed description
Executive dysfunction following brain injury (BI) is commonly observed and has been well documented in the literature (Mateer, 1999; Prigatano, 1999; Levine et al., 2000; Shallice \& Burgess, 1991; Cicerone \& Giacino, 1992; Goldman-Rakic, 1993; Lezak, 1995, Riegal \& Gauggel, 2002; McDonald, 2002; Stuss and Levine, 2003). Level of functioning such as vocational success, community reintegration, and social autonomy are associated with executive functioning abilities following BI (Mazaux et al. 1997, Sohlberg, Mateer, \& Stuss, 1993; (Stuss \& Levine, 2002, McDonald, 2002). Studies describing the rehabilitation of executive dysfunction have been limited to mostly single case or small group designs (Cicerone, et al., 2000). However, there have been three small randomized clinical trials that have had promising results suggesting the need for more research in this area. When considering all of the studies, it is evident that emphasis has been placed on three areas of intervention: attention remediation, emotional regulation and problem-solving. Consequently, given the pervasive disability found in individuals with BI that is secondary to executive function disorders and the promising, but limited, success of problem-solving-based interventions for executive functions, a randomized controlled trial (RCT) of the efficacy of a short-term, intensive executive function training program (Short-Term Executive Plus) is proposed. The Short-Term Executive Plus (STEP) program will combine treatments and treatment approaches that have proved to be effective in previous studies and will be compared to "wait-list" control group. This design was chosen because no appropriate control intervention exists. In other words there is no "standard" rehabilitation treatment available to these individuals that could serve as an appropriate "control" condition/treatment. As discussed earlier, cognitive remediation is typically delivered in extended full-time day treatment programs or weekly/bi-weekly individual sessions. Using more traditional extended treatments as a control condition would be inappropriate, as persons who can participate in extended, full-time are not the target of the proposed intervention. It is hypothesized that the STEP program will result in significant improvements in executive functioning (and related areas of attention, memory, community participation, and life satisfaction).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate start | Experimental | Behavioral: Immediate StartStarts the 12 week intervention immediately after enrollment |
| Waitlist group | Experimental | Behavioral: WaitlistStarts the 12 week intervention 12 weeks after initial enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be 18 years old or older;
- 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);
- Being at least three months post-injury;
- Being English-speaking (treatment sessions will be conducted in English);
- Reporting executive dysfunction (by self or family);
Key exclusion criteria (8 listed)
- Have diminished mental capacity and as a result, are unable to sign informed consent;
- Active substance abuse;
- Active psychosis;
- Active suicidality;
- Disruptive or violent behavior to self or others;
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 |
|---|---|---|
| Immediate StartParticipation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module. | Behavioural | Immediate start |
| WaitlistParticipation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module. | Behavioural | Waitlist group |
Primary outcome
Executive functioning
Time frame: At the beginning of the intervention
Executive functioning
Time frame: At 12 weeks
Executive functioning
Time frame: At 24 weeks
Executive functioning
Time frame: At 6 months
Executive functioning
Time frame: At 1 year post-intervention.
20 secondary outcomes
Attention
Time frame: At the beginning of the intervention
Attention
Time frame: At 12 weeks
Attention
Time frame: At 24 weeks
Attention
Time frame: At 6 months
Attention
Time frame: At 1 year post-intervention
Depression and anxiety
Time frame: At the beginning of the intervention
Depression and anxiety
Time frame: At 12 weeks
Depression and anxiety
Time frame: At 24 weeks
Depression and anxiety
Time frame: At 6 months
Depression and anxiety
Time frame: At 1 year post-intervention
Memory and learning
Time frame: At the beginning of the intervention
Memory and learning
Time frame: At 12 weeks
Memory and learning
Time frame: At 24 weeks
Memory and learning
Time frame: At 6 months
Memory and learning
Time frame: At 1 year post-intervention
Participation, life satisfaction, and self-efficacy
Time frame: At the beginning of the intervention
Participation, life satisfaction, and self-efficacy
Time frame: At 12 weeks
Participation, life satisfaction, and self-efficacy
Time frame: At 24 weeks
Participation, life satisfaction, and self-efficacy
Time frame: At 6 months
Participation, life satisfaction, and self-efficacy
Time frame: At 1 year post-intervention
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.
- Derived from this study: PubMed 23988395Cantor J, Ashman T, Dams-O'Connor K, Dijkers MP, Gordon W, Spielman L, Tsaousides T, Allen H, Nguyen M, Oswald J. Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil. 2014 Jan;95(1):1-9.e3. doi: 10.1016/j.apmr.2013.08.005. Epub 2013 Aug 27.
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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 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 Immediate Start and Waitlist 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 8 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?
Executive functioning (time frame: At the beginning of the intervention). 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?
On the ClinicalTrials.gov record for NCT00627237, 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 Sep 2013.