Rehabilitation for Improved Cognition
- Conditions
- Exhaustion; SyndromeBurnout Syndrome
- Interventions
- Behavioral: Computer-based cognitive trainingBehavioral: Physical fitness training
- Registration Number
- NCT03073772
- Lead Sponsor
- Umeå University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- 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
- Need of other treatment or rehabilitation
- Abuse of alcohol or drugs
- Participation in another intervention study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Computer-based cognitive training Computer-based cognitive training This arm also consisted of continued multimodal rehabilitation. Physical fitness training Physical fitness training This arm also consisted of continued multimodal rehabilitation.
- Primary Outcome Measures
Name Time Method Short-term change in global brain score 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 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
- Secondary Outcome Measures
Name Time Method Short-term change in "letter memory running span task" Week 12 and 24 A measure of the updating functioning
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 A measure of the updating functioning
Short-term change in "3-back task" Week 12 and 24 A measure of the updating functioning
Long-term change in "3-back task" Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects A measure of the updating functioning
Short-term change in the "colour word interference test (the Stroop test)" Week 12 and 24 A measure of the inhibition functioning, from D-KEFS
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 A measure of the inhibition functioning, from D-KEFS
Short-term change in the "trail making test" Week 12 and 24 A measure of attentional shifting, from D-KEFS
Long-term change in the "trail making test" Week 12, 24 and 76, mixed model with several time points to estimate long-term effects A measure of attentional shifting, from D-KEFS
Short-term change in the "digit span forward test" Week 12 and 24 A measure of the working memory, from WAIS-R
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 A measure of the working memory, from WAIS-R
Short-term change in the "digit span backward test" Week 12 and 24 A measure of the working memory, from WAIS-R
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 A measure of the working memory, from WAIS-R
Short-term change in the "letter-number sequencing" test Week 12 and 24 A measure of the working memory, from WAIS-III
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 A measure of the working memory, from WAIS-III
Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure) Week 12 and 24 A measure of the episodic memory
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 A measure of the episodic memory
Short-term change in the "digit symbol" test Week 12 and 24 A measure of perceptual speed, from WAIS-R
Long-term change in the "digit symbol" test Week 12, 24 and 76, mixed model with several time points to estimate long-term effects A measure of perceptual speed, from WAIS-R
Short-term change in "Raven's advanced progressive matrices" Week 12 and 24 A measure of non-verbal reasoning ability
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 A measure of non-verbal reasoning ability
Short-term change in Shirom Melamed Burnout Questionnaire Week 12 and 24 A burnout measure
Long-term change in Shirom Melamed Burnout Questionnaire Week 12, 24 and 76, mixed model with several time points to estimate long-term effects A burnout measure
Short-term change in Short Form 36 item Health Questionnaire Week 12 and 24 Health-related quality of life estimate
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 Health-related quality of life estimate
Short-term change in Checklist Individual Strength Questionnaire Week 12 and 24 Measure of fatigue
Long-term change in Checklist Individual Strength Questionnaire Week 12, 24 and 76, mixed model with several time points to estimate long-term effects Measure of fatigue
Short-term change in Hospital Anxiety and Depression Scale, HAD-S Week 12 and 24 A measure of anxiety and depression
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 A measure of anxiety and depression
Short-term change in aerobic capacity Week 12 and 24 A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Long-term change in aerobic capacity Week 12, 24 and 76, mixed model with several time points to estimate long-term effects A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Short-term change in work ability Week 12 and 24 Work Ability Index questionnaire, short version
Long-term change in work ability Week 12, 24 and 76, mixed model with several time points to estimate long-term effects Work Ability Index questionnaire, short version
Long-term total sick leave change Week 12, 24 and 76, mixed model with several time points to estimate long-term effects Information about sick leave from registers at the Social Insurance Agency in Sweden
Long-term cost-effectiveness Week 12, 24 and 76, mixed model with several time points to estimate long-term effects Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey
Trial Locations
- Locations (1)
Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council
🇸🇪Umea, Sweden