Clinical trial NCT03073772: Rehabilitation for Improved Cognition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exhaustion; Syndrome
Burnout Syndrome
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Västerbotten County Council, Sweden
name: Swedish Social Insurance Agency
First posted: 2017-03-08
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Short-term change in global brain score
timeFrame: Week 12 and 24
measure: Long-term change in global brain score
timeFrame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
Secondary outcomes:
measure: Short-term change in "letter memory running span task"
timeFrame: Week 12 and 24
measure: Long-term change in "letter memory running span task"
timeFrame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
measure: Short-term change in "3-back task"
timeFrame: Week 12 and 24
measure: Long-term change in "3-back task"
timeFrame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
measure: Short-term change in the "colour word interference test (the Stroop test)"
timeFrame: Week 12 and 24
measure: Long-term change in the "colour word interference test (the Stroop test)"
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in the "trail making test"
timeFrame: Week 12 and 24
measure: Long-term change in the "trail making test"
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in the "digit span forward test"
timeFrame: Week 12 and 24
measure: Long-term change in the "digit span forward test"
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in the "digit span backward test"
timeFrame: Week 12 and 24
measure: Long-term change in the "digit span backward test"
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in the "letter-number sequencing" test
timeFrame: Week 12 and 24
measure: Long-term change in the "letter-number sequencing" test
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
timeFrame: Week 12 and 24
measure: Long-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in the "digit symbol" test
timeFrame: Week 12 and 24
measure: Long-term change in the "digit symbol" test
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in "Raven's advanced progressive matrices"
timeFrame: Week 12 and 24
measure: Long-term change in "Raven's advanced progressive matrices"
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in Shirom Melamed Burnout Questionnaire
timeFrame: Week 12 and 24
measure: Long-term change in Shirom Melamed Burnout Questionnaire
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in Short Form 36 item Health Questionnaire
timeFrame: Week 12 and 24
measure: Long-term change in Short Form 36 item Health Questionnaire
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in Checklist Individual Strength Questionnaire
timeFrame: Week 12 and 24
measure: Long-term change in Checklist Individual Strength Questionnaire
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in Hospital Anxiety and Depression Scale, HAD-S
timeFrame: Week 12 and 24
measure: Long-term change in Hospital Anxiety and Depression Scale, HAD-S
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in aerobic capacity
timeFrame: Week 12 and 24
measure: Long-term change in aerobic capacity
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Short-term change in work ability
timeFrame: Week 12 and 24
measure: Long-term change in work ability
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Long-term total sick leave change
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
measure: Long-term cost-effectiveness
timeFrame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council
Study officials:
affiliation: Umeå University
name: Lisbeth Slunga Järvholm, MD, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.