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Completed

NCT Number: NCT00233129

Improving Executive Functions After Traumatic Brain Injury (TBI): A 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.

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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

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Top Down

Behavioral

Six months

Other names: Executive Plus Day Treatment Program

cognitive rehabilitation day treatment program

Other

six months

Primary outcomes

  1. Cognitive function

    Time frame: At baseline

  2. Cognitive function

    Time frame: 5 weeks into treatment

  3. Cognitive function

    Time frame: At treatment end (6 months after baseline)

  4. Cognitive function

    Time frame: 6 months after completing treatment

  5. Cognitive function

    Time frame: 12 months after completing treatment

Secondary outcomes

  1. Memory

    Time frame: At baseline

  2. Memory

    Time frame: 5 weeks into treatment

  3. Memory

    Time frame: At treatment end (6 months after baseline)

  4. Memory

    Time frame: 6 months after completing treatment

  5. Memory

    Time frame: 12 months after completing treatment

  6. Learning

    Time frame: At baseline

  7. Learning

    Time frame: 5 weeks into treatment

  8. Learning

    Time frame: At treatment end (6 months after baseline)

  9. Learning

    Time frame: 6 months after completing treatment

  10. Learning

    Time frame: 12 months after completing treatment

  11. Participation

    Time frame: At baseline

  12. Participation

    Time frame: 5 weeks into treatment

  13. Participation

    Time frame: At treatment end (6 months after baseline)

  14. Participation

    Time frame: 6 months after completing treatment

  15. Participation

    Time frame: 12 months after completing treatment

  16. Affective distress

    Time frame: At baseline

  17. Affective distress

    Time frame: 5 weeks into treatment

  18. Affective distress

    Time frame: At treatment end (6 months after baseline)

  19. Affective distress

    Time frame: 6 months after completing treatment

  20. Affective distress

    Time frame: 12 months after completing treatment

  21. Life satisfaction and self-efficacy

    Time frame: At baseline

  22. Life satisfaction and self-efficacy

    Time frame: 5 weeks into treatment

  23. Life satisfaction and self-efficacy

    Time frame: At treatment end (6 months after baseline)

  24. Life satisfaction and self-efficacy

    Time frame: 6 months after completing treatment

  25. Life satisfaction and self-efficacy

    Time frame: 12 months after completing treatment

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 5, 2005
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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