Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Executive functioning
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Immediate start
Starts the 12 week intervention immediately after enrollment
干预措施: Immediate Start (Behavioral)
Waitlist group
Starts the 12 week intervention 12 weeks after initial enrollment
干预措施: Waitlist (Behavioral)
结局指标
主要结局
Executive functioning
时间窗: At 1 year post-intervention.
Executive functioning
时间窗: At the beginning of the intervention
Executive functioning
时间窗: At 12 weeks
Executive functioning
时间窗: At 24 weeks
Executive functioning
时间窗: At 6 months
次要结局
- Attention(At 1 year post-intervention)
- Participation, life satisfaction, and self-efficacy(At 1 year post-intervention)
- Depression and anxiety(At 1 year post-intervention)
- Memory and learning(At 1 year post-intervention)
- Attention(At 12 weeks)
- Attention(At 24 weeks)
- Attention(At the beginning of the intervention)
- Attention(At 6 months)
- Depression and anxiety(At the beginning of the intervention)
- Depression and anxiety(At 12 weeks)
- Depression and anxiety(At 24 weeks)
- Depression and anxiety(At 6 months)
- Memory and learning(At the beginning of the intervention)
- Memory and learning(At 12 weeks)
- Memory and learning(At 24 weeks)
- Memory and learning(At 6 months)
- Participation, life satisfaction, and self-efficacy(At the beginning of the intervention)
- Participation, life satisfaction, and self-efficacy(At 12 weeks)
- Participation, life satisfaction, and self-efficacy(At 24 weeks)
- Participation, life satisfaction, and self-efficacy(At 6 months)