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Rehabilitation for Improved Cognition (RECO)

Primary Purpose

Exhaustion; Syndrome, Burnout Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Computer-based cognitive training
Physical fitness training
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exhaustion; Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Continued multimodal rehabilitation

Computer-based cognitive training

Physical fitness training

Arm Description

No addition of extra training in this group. Only ordinary continued multimodal rehabilitation.

This arm also consisted of continued multimodal rehabilitation.

This arm also consisted of continued multimodal rehabilitation.

Outcomes

Primary Outcome Measures

Short-term change in global brain score
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Long-term change in global brain score
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning

Secondary Outcome Measures

Short-term change in "letter memory running span task"
A measure of the updating functioning
Long-term change in "letter memory running span task"
A measure of the updating functioning
Short-term change in "3-back task"
A measure of the updating functioning
Long-term change in "3-back task"
A measure of the updating functioning
Short-term change in the "colour word interference test (the Stroop test)"
A measure of the inhibition functioning, from D-KEFS
Long-term change in the "colour word interference test (the Stroop test)"
A measure of the inhibition functioning, from D-KEFS
Short-term change in the "trail making test"
A measure of attentional shifting, from D-KEFS
Long-term change in the "trail making test"
A measure of attentional shifting, from D-KEFS
Short-term change in the "digit span forward test"
A measure of the working memory, from WAIS-R
Long-term change in the "digit span forward test"
A measure of the working memory, from WAIS-R
Short-term change in the "digit span backward test"
A measure of the working memory, from WAIS-R
Long-term change in the "digit span backward test"
A measure of the working memory, from WAIS-R
Short-term change in the "letter-number sequencing" test
A measure of the working memory, from WAIS-III
Long-term change in the "letter-number sequencing" test
A measure of the working memory, from WAIS-III
Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
A measure of the episodic memory
Long-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
A measure of the episodic memory
Short-term change in the "digit symbol" test
A measure of perceptual speed, from WAIS-R
Long-term change in the "digit symbol" test
A measure of perceptual speed, from WAIS-R
Short-term change in "Raven's advanced progressive matrices"
A measure of non-verbal reasoning ability
Long-term change in "Raven's advanced progressive matrices"
A measure of non-verbal reasoning ability
Short-term change in Shirom Melamed Burnout Questionnaire
A burnout measure
Long-term change in Shirom Melamed Burnout Questionnaire
A burnout measure
Short-term change in Short Form 36 item Health Questionnaire
Health-related quality of life estimate
Long-term change in Short Form 36 item Health Questionnaire
Health-related quality of life estimate
Short-term change in Checklist Individual Strength Questionnaire
Measure of fatigue
Long-term change in Checklist Individual Strength Questionnaire
Measure of fatigue
Short-term change in Hospital Anxiety and Depression Scale, HAD-S
A measure of anxiety and depression
Long-term change in Hospital Anxiety and Depression Scale, HAD-S
A measure of anxiety and depression
Short-term change in aerobic capacity
A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Long-term change in aerobic capacity
A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Short-term change in work ability
Work Ability Index questionnaire, short version
Long-term change in work ability
Work Ability Index questionnaire, short version
Long-term total sick leave change
Information about sick leave from registers at the Social Insurance Agency in Sweden
Long-term cost-effectiveness
Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey

Full Information

First Posted
February 22, 2017
Last Updated
March 2, 2017
Sponsor
Umeå University
Collaborators
Västerbotten County Council, Sweden, Swedish Social Insurance Agency
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1. Study Identification

Unique Protocol Identification Number
NCT03073772
Brief Title
Rehabilitation for Improved Cognition
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2010 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Västerbotten County Council, Sweden, Swedish Social Insurance Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exhaustion; Syndrome, Burnout Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continued multimodal rehabilitation
Arm Type
No Intervention
Arm Description
No addition of extra training in this group. Only ordinary continued multimodal rehabilitation.
Arm Title
Computer-based cognitive training
Arm Type
Active Comparator
Arm Description
This arm also consisted of continued multimodal rehabilitation.
Arm Title
Physical fitness training
Arm Type
Active Comparator
Arm Description
This arm also consisted of continued multimodal rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based cognitive training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical fitness training
Intervention Description
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 Outcome Measure Information:
Title
Short-term change in global brain score
Description
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Time Frame
Week 12 and 24
Title
Long-term change in global brain score
Description
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Time Frame
Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
Secondary Outcome Measure Information:
Title
Short-term change in "letter memory running span task"
Description
A measure of the updating functioning
Time Frame
Week 12 and 24
Title
Long-term change in "letter memory running span task"
Description
A measure of the updating functioning
Time Frame
Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
Title
Short-term change in "3-back task"
Description
A measure of the updating functioning
Time Frame
Week 12 and 24
Title
Long-term change in "3-back task"
Description
A measure of the updating functioning
Time Frame
Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
Title
Short-term change in the "colour word interference test (the Stroop test)"
Description
A measure of the inhibition functioning, from D-KEFS
Time Frame
Week 12 and 24
Title
Long-term change in the "colour word interference test (the Stroop test)"
Description
A measure of the inhibition functioning, from D-KEFS
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in the "trail making test"
Description
A measure of attentional shifting, from D-KEFS
Time Frame
Week 12 and 24
Title
Long-term change in the "trail making test"
Description
A measure of attentional shifting, from D-KEFS
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in the "digit span forward test"
Description
A measure of the working memory, from WAIS-R
Time Frame
Week 12 and 24
Title
Long-term change in the "digit span forward test"
Description
A measure of the working memory, from WAIS-R
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in the "digit span backward test"
Description
A measure of the working memory, from WAIS-R
Time Frame
Week 12 and 24
Title
Long-term change in the "digit span backward test"
Description
A measure of the working memory, from WAIS-R
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in the "letter-number sequencing" test
Description
A measure of the working memory, from WAIS-III
Time Frame
Week 12 and 24
Title
Long-term change in the "letter-number sequencing" test
Description
A measure of the working memory, from WAIS-III
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
Description
A measure of the episodic memory
Time Frame
Week 12 and 24
Title
Long-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
Description
A measure of the episodic memory
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in the "digit symbol" test
Description
A measure of perceptual speed, from WAIS-R
Time Frame
Week 12 and 24
Title
Long-term change in the "digit symbol" test
Description
A measure of perceptual speed, from WAIS-R
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in "Raven's advanced progressive matrices"
Description
A measure of non-verbal reasoning ability
Time Frame
Week 12 and 24
Title
Long-term change in "Raven's advanced progressive matrices"
Description
A measure of non-verbal reasoning ability
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in Shirom Melamed Burnout Questionnaire
Description
A burnout measure
Time Frame
Week 12 and 24
Title
Long-term change in Shirom Melamed Burnout Questionnaire
Description
A burnout measure
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in Short Form 36 item Health Questionnaire
Description
Health-related quality of life estimate
Time Frame
Week 12 and 24
Title
Long-term change in Short Form 36 item Health Questionnaire
Description
Health-related quality of life estimate
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in Checklist Individual Strength Questionnaire
Description
Measure of fatigue
Time Frame
Week 12 and 24
Title
Long-term change in Checklist Individual Strength Questionnaire
Description
Measure of fatigue
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in Hospital Anxiety and Depression Scale, HAD-S
Description
A measure of anxiety and depression
Time Frame
Week 12 and 24
Title
Long-term change in Hospital Anxiety and Depression Scale, HAD-S
Description
A measure of anxiety and depression
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in aerobic capacity
Description
A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Time Frame
Week 12 and 24
Title
Long-term change in aerobic capacity
Description
A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Short-term change in work ability
Description
Work Ability Index questionnaire, short version
Time Frame
Week 12 and 24
Title
Long-term change in work ability
Description
Work Ability Index questionnaire, short version
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Long-term total sick leave change
Description
Information about sick leave from registers at the Social Insurance Agency in Sweden
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Title
Long-term cost-effectiveness
Description
Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey
Time Frame
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisbeth Slunga Järvholm, MD, Ass Prof
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council
City
Umea
ZIP/Postal Code
90333
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34006315
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.
Results Reference
derived
PubMed Identifier
29693483
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.
Results Reference
derived
PubMed Identifier
28865430
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.
Results Reference
derived

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Rehabilitation for Improved Cognition

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