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

NCT00627237 | Completed

• 2 other identifiers: GCO 06-0939CE001171
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Traumatic Brain Injury

Keywords

Brain Injuries; Cognitive Rehabilitation; Executive Functioning

Outcome Measures

Primary Outcomes (5)

• Executive functioning

  At the beginning of the intervention

• Executive functioning

  At 12 weeks

• Executive functioning

  At 24 weeks

• Executive functioning

  At 6 months

• Executive functioning

  At 1 year post-intervention.

Secondary Outcomes (20)

• Attention

  At the beginning of the intervention

• Attention

  At 12 weeks

• Attention

  At 24 weeks

• Attention

  At 6 months

• Attention

  At 1 year post-intervention

Study Arms (2)

Immediate start

EXPERIMENTAL

Starts the 12 week intervention immediately after enrollment

Behavioral: Immediate Start

Waitlist group

EXPERIMENTAL

Starts the 12 week intervention 12 weeks after initial enrollment

Behavioral: Waitlist

Interventions

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.

Immediate start

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.

Waitlist group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

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

Location

Related Publications (1)

• 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.

  PMID: 23988395 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Wayne Gordon, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

US (1)