Rehabilitation for Improved Cognition (RECO)

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.

Study Overview

• Status: Completed
• Conditions: Burnout Syndrome; Exhaustion; Syndrome
• Intervention / Treatment: Behavioral: Computer-based cognitive training; Behavioral: Physical fitness training

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).

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umea, Sweden, 90333
    • Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Continued multimodal rehabilitation; No addition of extra training in this group. Only ordinary continued multimodal rehabilitation.
Active Comparator: Computer-based cognitive training; This arm also consisted of continued multimodal rehabilitation.	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.
Active Comparator: Physical fitness training; This arm also consisted of continued multimodal rehabilitation.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Västerbotten County Council, Sweden; Swedish Social Insurance Agency
• Investigators: Principal Investigator: Lisbeth Slunga Järvholm, MD, Ass Prof, Umea University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease; Stress, Psychological; Syndrome; Burnout, Psychological
• Other Study ID Numbers: REHSAM 99368-2009/RS09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No