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Completed

NCT Number: NCT00627237

Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the "Short Term Executive Plus" Program

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029-6574, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Immediate Start

Behavioral

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.

Waitlist

Behavioral

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.

Primary outcomes

  1. Executive functioning

    Time frame: At the beginning of the intervention

  2. Executive functioning

    Time frame: At 12 weeks

  3. Executive functioning

    Time frame: At 24 weeks

  4. Executive functioning

    Time frame: At 6 months

  5. Executive functioning

    Time frame: At 1 year post-intervention.

Secondary outcomes

  1. Attention

    Time frame: At the beginning of the intervention

  2. Attention

    Time frame: At 12 weeks

  3. Attention

    Time frame: At 24 weeks

  4. Attention

    Time frame: At 6 months

  5. Attention

    Time frame: At 1 year post-intervention

  6. Depression and anxiety

    Time frame: At the beginning of the intervention

  7. Depression and anxiety

    Time frame: At 12 weeks

  8. Depression and anxiety

    Time frame: At 24 weeks

  9. Depression and anxiety

    Time frame: At 6 months

  10. Depression and anxiety

    Time frame: At 1 year post-intervention

  11. Memory and learning

    Time frame: At the beginning of the intervention

  12. Memory and learning

    Time frame: At 12 weeks

  13. Memory and learning

    Time frame: At 24 weeks

  14. Memory and learning

    Time frame: At 6 months

  15. Memory and learning

    Time frame: At 1 year post-intervention

  16. Participation, life satisfaction, and self-efficacy

    Time frame: At the beginning of the intervention

  17. Participation, life satisfaction, and self-efficacy

    Time frame: At 12 weeks

  18. Participation, life satisfaction, and self-efficacy

    Time frame: At 24 weeks

  19. Participation, life satisfaction, and self-efficacy

    Time frame: At 6 months

  20. Participation, life satisfaction, and self-efficacy

    Time frame: At 1 year post-intervention

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation.

Acronym: STEP

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Feb 29, 2008
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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