NCT00233129

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

5.1 years

First QC Date

October 3, 2005

Last Update Submit

September 23, 2013

Conditions

Traumatic Brain Injury

Keywords

Day treatmentexecutive functionproblem solvingattentionparticipationTBIbrain injurytraumatic brain injury

Outcome Measures

Primary Outcomes (5)

  • Cognitive function

    At baseline

  • Cognitive function

    5 weeks into treatment

  • Cognitive function

    At treatment end (6 months after baseline)

  • Cognitive function

    6 months after completing treatment

  • Cognitive function

    12 months after completing treatment

Secondary Outcomes (25)

  • Memory

    At baseline

  • Memory

    5 weeks into treatment

  • Memory

    At treatment end (6 months after baseline)

  • Memory

    6 months after completing treatment

  • Memory

    12 months after completing treatment

  • +20 more secondary outcomes

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

cognitive rehabilitation day treatment program

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.

Behavioral: Top Down

Interventions

Top DownBEHAVIORAL

Six months

Also known as: Executive Plus Day Treatment Program
Top-Down
cognitive rehabilitation day treatment programOTHER

six months

Standard Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Wayne A Gordon, Ph.D.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(1)