Effects on Cognitive Function, Estimated as a Global Brain Score, by Cognitive and Physical Fitness Training Added to a Multimodal Rehabilitation Program for Patients With Exhaustion Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Short-term change in global brain score
研究概览
简要总结
Many patients with exhaustion disorders continue to have significant difficulties with attention and memory function which reduce their work ability. This randomized study investigates whether the addition of a 12-week period of specific cognitive training or physical fitness training could further enhance cognitive function in patients with exhaustion disorder participating in a multimodal rehabilitation program.
详细描述
This study was performed at The Stress Rehabilitation Clinic at the University hospital of Umeå. In total 161 patients with diagnosed exhaustion disorder were recruited consecutively to the study from March 2010 until June 2013. Participants were all in age span 18-60 years old, had an ongoing employment and were assessed as suitable for a 24-week multimodal rehabilitation, which consisted of cognitive behavioural therapy in group (maximum eight persons), prescription of physical activity/exercise (FaR©) and vocational measures with rehabilitation meetings. A randomization by group was performed after 12 weeks of multimodal rehabilitation to one of three conditions; A/ continued multimodal rehabilitation, B/ addition of a computer-based cognitive training, and C/ addition of physical fitness training. The added training was performed during the last 12 weeks of rehabilitation (week 12 to 24) and with three weekly training occasions. Primary endpoint was change in cognitive functioning, estimated as a global brain score. Secondary endpoints were changes in different specific neuropsychological tasks, estimated psychological wellbeing, physical capacity, work ability, health-related quality of life and cost-effectiveness. A long-term follow-up was performed one year after termination of the interventions (at week 76).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
- •18 - 60 years of age
- •Current employment
- •Considered suitable for multimodal rehabilitation in group
排除标准
- •Need of other treatment or rehabilitation
- •Abuse of alcohol or drugs
- •Participation in another intervention study
研究组 & 干预措施
Continued multimodal rehabilitation
No addition of extra training in this group. Only ordinary continued multimodal rehabilitation.
Computer-based cognitive training
This arm also consisted of continued multimodal rehabilitation.
干预措施: Computer-based cognitive training (Behavioral)
Physical fitness training
This arm also consisted of continued multimodal rehabilitation.
干预措施: Physical fitness training (Behavioral)
结局指标
主要结局
Short-term change in global brain score
时间窗: Week 12 and 24
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Long-term change in global brain score
时间窗: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
次要结局
- Short-term change in the "letter-number sequencing" test(Week 12 and 24)
- Long-term change in the "letter-number sequencing" test(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)(Week 12 and 24)
- Short-term change in the "digit symbol" test(Week 12 and 24)
- Long-term change in the "digit symbol" test(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in "Raven's advanced progressive matrices"(Week 12 and 24)
- Long-term change in "Raven's advanced progressive matrices"(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in Shirom Melamed Burnout Questionnaire(Week 12 and 24)
- Long-term change in Shirom Melamed Burnout Questionnaire(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in Short Form 36 item Health Questionnaire(Week 12 and 24)
- Long-term change in Short Form 36 item Health Questionnaire(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in Checklist Individual Strength Questionnaire(Week 12 and 24)
- Long-term change in Checklist Individual Strength Questionnaire(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in Hospital Anxiety and Depression Scale, HAD-S(Week 12 and 24)
- Long-term change in Hospital Anxiety and Depression Scale, HAD-S(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in aerobic capacity(Week 12 and 24)
- Long-term change in aerobic capacity(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Long-term change in "letter memory running span task"(Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects)
- Short-term change in "3-back task"(Week 12 and 24)
- Long-term change in "3-back task"(Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects)
- Short-term change in the "colour word interference test (the Stroop test)"(Week 12 and 24)
- Short-term change in "letter memory running span task"(Week 12 and 24)
- Long-term change in the "colour word interference test (the Stroop test)"(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in the "trail making test"(Week 12 and 24)
- Long-term change in the "trail making test"(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in the "digit span forward test"(Week 12 and 24)
- Long-term change in the "digit span forward test"(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in the "digit span backward test"(Week 12 and 24)
- Long-term change in the "digit span backward test"(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Long-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Short-term change in work ability(Week 12 and 24)
- Long-term change in work ability(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Long-term total sick leave change(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)
- Long-term cost-effectiveness(Week 12, 24 and 76, mixed model with several time points to estimate long-term effects)