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

Condition(s) targeted: Traumatic Brain Injury

Intervention: Cognitive Rehabilitation (Behavioral); Delayed Cognitive Rehabilitation (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Mount Sinai School of Medicine

Official(s) and/or principal investigator(s):
Wayne Gordon, Ph.D., Principal Investigator, Affiliation: Mount Sinai School of Medicine

Overall contact:
Hafina Allen, Phone: 212-241-4820, Email: Hafina.allen@mountsinai.org

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).

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

Study design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome:

Executive functioning

Attention

Depression and anxiety

Memory and learning

Participation and life satisfaction

Secondary outcome: Demographics

Detailed description: 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). However, 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 study needed 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).

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be 18-55 years old (to avoid outcomes being affected by cognitive changes secondary

to aging, the sample will be restricted to younger adults);

- 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 two

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.

Hafina Allen, Phone: 212-241-4820, Email: Hafina.allen@mountsinai.org

Mount Sinai School of Medicine, New York, New York 10029-6574, United States; Recruiting
Wayne Gordon, Ph.D., Phone: 212-659-9372, Email: wayne.gordon@mssm.edu
Teresa Ashman, Ph.D., Phone: 212-241-2549, Email: teresa.ashman@mountsinai.org
Wayne Gordon, Ph.D., Principal Investigator
Joshua Cantor, Ph.D., Sub-Investigator
Teresa Ashman, Ph.D., Sub-Investigator

Starting date: January 2008
Ending date: August 2012
Last updated: December 18, 2008