Rehabilitation for Improved Cognition

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Exhaustion; Syndrome, Burnout Syndrome

Intervention / Treatment
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* Behavioral: Computer-based cognitive training
* Behavioral: Physical fitness training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Need of other treatment or rehabilitation Abuse of alcohol or drugs Participation in another intervention study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Continued multimodal rehabilitation<br>No addition of extra training in this group. Only ordinary continued multimodal rehabilitation. | |
| Active Comparator: Computer-based cognitive training<br>This arm also consisted of continued multimodal rehabilitation. | Behavioral: Computer-based cognitive training<br>* A total of 36 training sessions, approximately 20 minutes long each. Five different tasks were used in training all tapping different aspects of cognitive control such as updating, shifting, visuo-spatial working memory and episodic memory binding.<br>|
| Active Comparator: Physical fitness training<br>This arm also consisted of continued multimodal rehabilitation. | Behavioral: Physical fitness training<br>* A total of 36 training sessions, approximately 40 minutes long each, with physical fitness training performed as group indoor cycling. The participants were instructed to attain a load of approximately 65-80% of their maximum heart rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term change in global brain score | The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning | Week 12 and 24 | 
| Long-term change in global brain score | The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning | Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term change in letter memory running span task | A measure of the updating functioning | Week 12 and 24 | 
| Long-term change in letter memory running span task | A measure of the updating functioning | Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects | 
| Short-term change in 3-back task | A measure of the updating functioning | Week 12 and 24 | 
| Long-term change in 3-back task | A measure of the updating functioning | 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) | A measure of the inhibition functioning, from D-KEFS | Week 12 and 24 | 
| Long-term change in the colour word interference test (the Stroop test) | A measure of the inhibition functioning, from D-KEFS | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in the trail making test | A measure of attentional shifting, from D-KEFS | Week 12 and 24 | 
| Long-term change in the trail making test | A measure of attentional shifting, from D-KEFS | 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 | A measure of the working memory, from WAIS-R | Week 12 and 24 | 
| Long-term change in the digit span forward test | A measure of the working memory, from WAIS-R | 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 | A measure of the working memory, from WAIS-R | Week 12 and 24 | 
| Long-term change in the digit span backward test | A measure of the working memory, from WAIS-R | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in the letter-number sequencing test | A measure of the working memory, from WAIS-III | Week 12 and 24 | 
| Long-term change in the letter-number sequencing test | A measure of the working memory, from WAIS-III | 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) | A measure of the episodic memory | Week 12 and 24 | 
| Long-term change in the recall of concrete nouns test (Buschke's selective reminding procedure) | A measure of the episodic memory | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in the digit symbol test | A measure of perceptual speed, from WAIS-R | Week 12 and 24 | 
| Long-term change in the digit symbol test | A measure of perceptual speed, from WAIS-R | 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 | A measure of non-verbal reasoning ability | Week 12 and 24 | 
| Long-term change in Raven's advanced progressive matrices | A measure of non-verbal reasoning ability | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in Shirom Melamed Burnout Questionnaire | A burnout measure | Week 12 and 24 | 
| Long-term change in Shirom Melamed Burnout Questionnaire | A burnout measure | 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 | Health-related quality of life estimate | Week 12 and 24 | 
| Long-term change in Short Form 36 item Health Questionnaire | Health-related quality of life estimate | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in Checklist Individual Strength Questionnaire | Measure of fatigue | Week 12 and 24 | 
| Long-term change in Checklist Individual Strength Questionnaire | Measure of fatigue | 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 | A measure of anxiety and depression | Week 12 and 24 | 
| Long-term change in Hospital Anxiety and Depression Scale, HAD-S | A measure of anxiety and depression | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in aerobic capacity | A submaximal cycle ergometer test performed to estimate maximal oxygen uptake | Week 12 and 24 | 
| Long-term change in aerobic capacity | A submaximal cycle ergometer test performed to estimate maximal oxygen uptake | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Short-term change in work ability | Work Ability Index questionnaire, short version | Week 12 and 24 | 
| Long-term change in work ability | Work Ability Index questionnaire, short version | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Long-term total sick leave change | Information about sick leave from registers at the Social Insurance Agency in Sweden | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects | 
| Long-term cost-effectiveness | Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey | Week 12, 24 and 76, mixed model with several time points to estimate long-term effects |