Rehabilitation for Improved Cognition

Burnout Syndrome Clinical Trial

— RECO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073772
• Other study ID #: REHSAM 99368-2009/RS09
• Status: Completed
• Phase: N/A
• First received: February 22, 2017
• Last updated: March 2, 2017
• Start date: April 1, 2010
• Est. completion date: December 31, 2014

Study information

• Verified date: February 2017
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 function in patients with exhaustion disorder participating in a multimodal rehabilitation program.

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 information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout Syndrome
• Exhaustion; Syndrome
• Syndrome

Intervention

Behavioral:
• Computer-based cognitive training
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
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.

Locations

Country	Name	City	State
Sweden	Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council	Umea

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	Swedish Social Insurance Agency, Västerbotten County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Short-term change in "letter memory running span task"	A measure of the updating functioning	Week 12 and 24
Secondary	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
Secondary	Short-term change in "3-back task"	A measure of the updating functioning	Week 12 and 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Short-term change in the "trail making test"	A measure of attentional shifting, from D-KEFS	Week 12 and 24
Secondary	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
Secondary	Short-term change in the "digit span forward test"	A measure of the working memory, from WAIS-R	Week 12 and 24
Secondary	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
Secondary	Short-term change in the "digit span backward test"	A measure of the working memory, from WAIS-R	Week 12 and 24
Secondary	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
Secondary	Short-term change in the "letter-number sequencing" test	A measure of the working memory, from WAIS-III	Week 12 and 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Short-term change in the "digit symbol" test	A measure of perceptual speed, from WAIS-R	Week 12 and 24
Secondary	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
Secondary	Short-term change in "Raven's advanced progressive matrices"	A measure of non-verbal reasoning ability	Week 12 and 24
Secondary	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
Secondary	Short-term change in Shirom Melamed Burnout Questionnaire	A burnout measure	Week 12 and 24
Secondary	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
Secondary	Short-term change in Short Form 36 item Health Questionnaire	Health-related quality of life estimate	Week 12 and 24
Secondary	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
Secondary	Short-term change in Checklist Individual Strength Questionnaire	Measure of fatigue	Week 12 and 24
Secondary	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
Secondary	Short-term change in Hospital Anxiety and Depression Scale, HAD-S	A measure of anxiety and depression	Week 12 and 24
Secondary	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
Secondary	Short-term change in aerobic capacity	A submaximal cycle ergometer test performed to estimate maximal oxygen uptake	Week 12 and 24
Secondary	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
Secondary	Short-term change in work ability	Work Ability Index questionnaire, short version	Week 12 and 24
Secondary	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
Secondary	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
Secondary	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