Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233129
• Other study ID #: GCO# 04-0782
• Secondary ID: #H133B040033
• Status: Completed
• Phase: N/A
• First received: October 3, 2005
• Last updated: September 23, 2013
• Start date: October 2005
• Est. completion date: November 2010

Study information

• Verified date: September 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Behavioral:
• Top Down
Six months

Other:
• cognitive rehabilitation day treatment program
six months

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function		At baseline	No
Primary	Cognitive function		5 weeks into treatment	No
Primary	Cognitive function		At treatment end (6 months after baseline)	No
Primary	Cognitive function		6 months after completing treatment	No
Primary	Cognitive function		12 months after completing treatment	No
Secondary	Memory		At baseline	No
Secondary	Memory		5 weeks into treatment	No
Secondary	Memory		At treatment end (6 months after baseline)	No
Secondary	Memory		6 months after completing treatment	No
Secondary	Memory		12 months after completing treatment	No
Secondary	Learning		At baseline	No
Secondary	Learning		5 weeks into treatment	No
Secondary	Learning		At treatment end (6 months after baseline)	No
Secondary	Learning		6 months after completing treatment	No
Secondary	Learning		12 months after completing treatment	No
Secondary	Participation		At baseline	No
Secondary	Participation		5 weeks into treatment	No
Secondary	Participation		At treatment end (6 months after baseline)	No
Secondary	Participation		6 months after completing treatment	No
Secondary	Participation		12 months after completing treatment	No
Secondary	Affective distress		At baseline	No
Secondary	Affective distress		5 weeks into treatment	No
Secondary	Affective distress		At treatment end (6 months after baseline)	No
Secondary	Affective distress		6 months after completing treatment	No
Secondary	Affective distress		12 months after completing treatment	No
Secondary	Life satisfaction and self-efficacy		At baseline	No
Secondary	Life satisfaction and self-efficacy		5 weeks into treatment	No
Secondary	Life satisfaction and self-efficacy		At treatment end (6 months after baseline)	No
Secondary	Life satisfaction and self-efficacy		6 months after completing treatment	No
Secondary	Life satisfaction and self-efficacy		12 months after completing treatment	No