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Completed

NCT Number: NCT03073772

Rehabilitation for Improved Cognition

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.

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Key information

Conditions

Exhaustion; Syndrome Behavior Behavioral Symptoms Burnout Syndrome Burnout, Psychological Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Stress, Psychological Syndrome

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council

Umeå, 90333, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-based Cognitive Training

Behavioral

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.

Physical fitness training

Behavioral

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.

Primary outcomes

  1. Short-term change in global brain score

    Time frame: Week 12 and 24

    The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning

  2. Long-term change in global brain score

    Time frame: 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 outcomes

  1. Short-term change in "letter memory running span task"

    Time frame: Week 12 and 24

    A measure of the updating functioning

  2. Long-term change in "letter memory running span task"

    Time frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects

    A measure of the updating functioning

  3. Short-term change in "3-back task"

    Time frame: Week 12 and 24

    A measure of the updating functioning

  4. Long-term change in "3-back task"

    Time frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects

    A measure of the updating functioning

  5. Short-term change in the "colour word interference test (the Stroop test)"

    Time frame: Week 12 and 24

    A measure of the inhibition functioning, from D-KEFS

  6. Long-term change in the "colour word interference test (the Stroop test)"

    Time frame: 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

  7. Short-term change in the "trail making test"

    Time frame: Week 12 and 24

    A measure of attentional shifting, from D-KEFS

  8. Long-term change in the "trail making test"

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    A measure of attentional shifting, from D-KEFS

  9. Short-term change in the "digit span forward test"

    Time frame: Week 12 and 24

    A measure of the working memory, from WAIS-R

  10. Long-term change in the "digit span forward test"

    Time frame: 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

  11. Short-term change in the "digit span backward test"

    Time frame: Week 12 and 24

    A measure of the working memory, from WAIS-R

  12. Long-term change in the "digit span backward test"

    Time frame: 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

  13. Short-term change in the "letter-number sequencing" test

    Time frame: Week 12 and 24

    A measure of the working memory, from WAIS-III

  14. Long-term change in the "letter-number sequencing" test

    Time frame: 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

  15. Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)

    Time frame: Week 12 and 24

    A measure of the episodic memory

  16. Long-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    A measure of the episodic memory

  17. Short-term change in the "digit symbol" test

    Time frame: Week 12 and 24

    A measure of perceptual speed, from WAIS-R

  18. Long-term change in the "digit symbol" test

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    A measure of perceptual speed, from WAIS-R

  19. Short-term change in "Raven's advanced progressive matrices"

    Time frame: Week 12 and 24

    A measure of non-verbal reasoning ability

  20. Long-term change in "Raven's advanced progressive matrices"

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    A measure of non-verbal reasoning ability

  21. Short-term change in Shirom Melamed Burnout Questionnaire

    Time frame: Week 12 and 24

    A burnout measure

  22. Long-term change in Shirom Melamed Burnout Questionnaire

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    A burnout measure

  23. Short-term change in Short Form 36 item Health Questionnaire

    Time frame: Week 12 and 24

    Health-related quality of life estimate

  24. Long-term change in Short Form 36 item Health Questionnaire

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    Health-related quality of life estimate

  25. Short-term change in Checklist Individual Strength Questionnaire

    Time frame: Week 12 and 24

    Measure of fatigue

  26. Long-term change in Checklist Individual Strength Questionnaire

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    Measure of fatigue

  27. Short-term change in Hospital Anxiety and Depression Scale, HAD-S

    Time frame: Week 12 and 24

    A measure of anxiety and depression

  28. Long-term change in Hospital Anxiety and Depression Scale, HAD-S

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    A measure of anxiety and depression

  29. Short-term change in aerobic capacity

    Time frame: Week 12 and 24

    A submaximal cycle ergometer test performed to estimate maximal oxygen uptake

  30. Long-term change in aerobic capacity

    Time frame: 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

  31. Short-term change in work ability

    Time frame: Week 12 and 24

    Work Ability Index questionnaire, short version

  32. Long-term change in work ability

    Time frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

    Work Ability Index questionnaire, short version

  33. Long-term total sick leave change

    Time frame: 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

  34. Long-term cost-effectiveness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Swedish Social Insurance Agency
  • Västerbotten County Council, Sweden

Registry information

Official study title

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

Acronym: RECO

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2017
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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