A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- California Verbal Learning Test
研究概览
简要总结
The current RCT is designed to:
- test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
- assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other
- evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
- evaluate the long-term effects of the treatment protocol.
To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).
详细描述
Outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. A long-term follow-up assessment will be conducted, designed to measure the impact of the mSMT 3 months following treatment completion. Alternate forms will be utilized wherever available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I am between the ages of 18-
- •I have had a Traumatic Brain Injury at least one year ago.
- •I can read and speak English fluently.
- •I have difficulties with learning and memory skills.
排除标准
- •I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
- •I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
- •I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
- •I have unstable or uncontrolled seizures.
- •I have a significant alcohol or drug abuse history.
研究组 & 干预措施
Placebo
Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
干预措施: Placebo controlled group memory exercise training (Behavioral)
Group memory retraining
Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
干预措施: Group Memory retraining exercises (Behavioral)
结局指标
主要结局
California Verbal Learning Test
时间窗: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Change on scores on memory tests will be assessed using the California Verbal Learning Test
The Traumatic Brain Injury-Quality of Life Scale
时间窗: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).
次要结局
未报告次要终点
研究者
Nancy Chiaravalloti
Director NNL & TBI
Kessler Foundation