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Exhaustion; SyndromeRECONCT03073772

Rehabilitation for Improved Cognition

A study testing Computer-based cognitive training and Physical fitness training in people with Exhaustion; Syndrome and Burnout Syndrome, run by Umeå University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Exhaustion; Syndrome, Burnout Syndrome
What is being tested?
Computer-based cognitive training and Physical fitness training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteSweden
Study dates
1 Apr 2010to 31 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Need of other treatment or rehabilitation
  • Abuse of alcohol or drugs
  • Participation in another intervention study

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council

    Umeå, 90333

Other trials in Sweden

About this study

Official 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

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.

Read the 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).

Being tested
Computer-based cognitive training, Physical fitness training
Medical subject headings
Syndrome, Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer-based cognitive trainingBehavioural

    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 trainingBehavioural

    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.

Study groups in NCT03073772
Study groupRoleWhat they receive
Continued multimodal rehabilitationNo interventionNo addition of extra training in this group. Only ordinary continued multimodal rehabilitation.
Computer-based cognitive trainingActive comparatorThis arm also consisted of continued multimodal rehabilitation.
Receives: Behavioral: Computer-based cognitive training
Physical fitness trainingActive comparatorThis arm also consisted of continued multimodal rehabilitation.
Receives: Behavioral: Physical fitness training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term change in global brain score

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

    Measured: Week 12 and 24

  2. Long-term change in global brain score

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

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

Secondary outcomes (34)
  1. Short-term change in "letter memory running span task"

    A measure of the updating functioning

    Measured: Week 12 and 24

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

    A measure of the updating functioning

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

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

    A measure of the updating functioning

    Measured: Week 12 and 24

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

    A measure of the updating functioning

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

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

    A measure of the inhibition functioning, from D-KEFS

    Measured: Week 12 and 24

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

    A measure of the inhibition functioning, from D-KEFS

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

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

    A measure of attentional shifting, from D-KEFS

    Measured: Week 12 and 24

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

    A measure of attentional shifting, from D-KEFS

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

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

    A measure of the working memory, from WAIS-R

    Measured: Week 12 and 24

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

    A measure of the working memory, from WAIS-R

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

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

    A measure of the working memory, from WAIS-R

    Measured: Week 12 and 24

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

    A measure of the working memory, from WAIS-R

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

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

    A measure of the working memory, from WAIS-III

    Measured: Week 12 and 24

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

    A measure of the working memory, from WAIS-III

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

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

    A measure of the episodic memory

    Measured: Week 12 and 24

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

    A measure of the episodic memory

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

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

    A measure of perceptual speed, from WAIS-R

    Measured: Week 12 and 24

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

    A measure of perceptual speed, from WAIS-R

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

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

    A measure of non-verbal reasoning ability

    Measured: Week 12 and 24

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

    A measure of non-verbal reasoning ability

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

  21. Short-term change in Shirom Melamed Burnout Questionnaire

    A burnout measure

    Measured: Week 12 and 24

  22. Long-term change in Shirom Melamed Burnout Questionnaire

    A burnout measure

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

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

    Health-related quality of life estimate

    Measured: Week 12 and 24

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

    Health-related quality of life estimate

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

  25. Short-term change in Checklist Individual Strength Questionnaire

    Measure of fatigue

    Measured: Week 12 and 24

  26. Long-term change in Checklist Individual Strength Questionnaire

    Measure of fatigue

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

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

    A measure of anxiety and depression

    Measured: Week 12 and 24

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

    A measure of anxiety and depression

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

  29. Short-term change in aerobic capacity

    A submaximal cycle ergometer test performed to estimate maximal oxygen uptake

    Measured: Week 12 and 24

  30. Long-term change in aerobic capacity

    A submaximal cycle ergometer test performed to estimate maximal oxygen uptake

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

  31. Short-term change in work ability

    Work Ability Index questionnaire, short version

    Measured: Week 12 and 24

  32. Long-term change in work ability

    Work Ability Index questionnaire, short version

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

  33. Long-term total sick leave change

    Information about sick leave from registers at the Social Insurance Agency in Sweden

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

  34. Long-term cost-effectiveness

    Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study start1 Apr 2010
  3. Primary completion31 Dec 2014
  4. Study completion31 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03073772
Sponsor's protocol ID
REHSAM 99368-2009/RS09
Acronym
RECO
Status last verified
Feb 2017
First submitted
22 Feb 2017
Last updated
8 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nelson A, Aronsson I, Tillfors M, Neely AS, Gavelin HM. The experienced route to cognitive health: Cognitive recovery in persons with prior stress-related Exhaustion disorder. BMC Psychiatry. 2025 Apr 14;25(1):375. doi: 10.1186/s12888-025-06713-7.

    PubMed 40229758
  • Nelson A, Gavelin HM, Boraxbekk CJ, Eskilsson T, Josefsson M, Slunga Jarvholm L, Neely AS. Subjective cognitive complaints in patients with stress-related exhaustion disorder: a cross sectional study. BMC Psychol. 2021 May 18;9(1):84. doi: 10.1186/s40359-021-00576-9.

    PubMed 34006315
  • Malmberg Gavelin H, Eskilsson T, Boraxbekk CJ, Josefsson M, Stigsdotter Neely A, Slunga Jarvholm L. Rehabilitation for improved cognition in patients with stress-related exhaustion disorder: RECO - a randomized clinical trial. Stress. 2018 Jul;21(4):279-291. doi: 10.1080/10253890.2018.1461833. Epub 2018 Apr 25.

    PubMed 29693483
  • Eskilsson T, Slunga Jarvholm L, Malmberg Gavelin H, Stigsdotter Neely A, Boraxbekk CJ. Aerobic training for improved memory in patients with stress-related exhaustion: a randomized controlled trial. BMC Psychiatry. 2017 Sep 2;17(1):322. doi: 10.1186/s12888-017-1457-1.

    PubMed 28865430

Questions about this trial

What is this clinical trial studying?

A study testing Computer-based cognitive training and Physical fitness training in people with Exhaustion; Syndrome and Burnout Syndrome, run by Umeå University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term change in global brain score (time frame: Week 12 and 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03073772, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.

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