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

Traumatic Brain Injury Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627237
• Other study ID #: GCO 06-0939
• Secondary ID: CE001171
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: September 23, 2013
• Start date: January 2008
• Est. completion date: July 2013

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

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).

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). 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 research 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Behavioral:
• Immediate Start
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
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.

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	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive functioning		At the beginning of the intervention	No
Primary	Executive functioning		At 12 weeks	No
Primary	Executive functioning		At 24 weeks	No
Primary	Executive functioning		At 6 months	No
Primary	Executive functioning		At 1 year post-intervention.	No
Secondary	Attention		At the beginning of the intervention	No
Secondary	Attention		At 12 weeks	No
Secondary	Attention		At 24 weeks	No
Secondary	Attention		At 6 months	No
Secondary	Attention		At 1 year post-intervention	No
Secondary	Depression and anxiety		At the beginning of the intervention	No
Secondary	Depression and anxiety		At 12 weeks	No
Secondary	Depression and anxiety		At 24 weeks	No
Secondary	Depression and anxiety		At 6 months	No
Secondary	Depression and anxiety		At 1 year post-intervention	No
Secondary	Memory and learning		At the beginning of the intervention	No
Secondary	Memory and learning		At 12 weeks	No
Secondary	Memory and learning		At 24 weeks	No
Secondary	Memory and learning		At 6 months	No
Secondary	Memory and learning		At 1 year post-intervention	No
Secondary	Participation, life satisfaction, and self-efficacy		At the beginning of the intervention	No
Secondary	Participation, life satisfaction, and self-efficacy		At 12 weeks	No
Secondary	Participation, life satisfaction, and self-efficacy		At 24 weeks	No
Secondary	Participation, life satisfaction, and self-efficacy		At 6 months	No
Secondary	Participation, life satisfaction, and self-efficacy		At 1 year post-intervention	No