Rehabilitation for Improved Cognition

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2014

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).

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Physical fitness training
    • This arm also consisted of continued multimodal rehabilitation.

Clinical Trial Outcome Measures

Primary Measures

  • Short-term change in global brain score
    • Time Frame: Week 12 and 24
    • The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
  • Long-term change in global brain score
    • Time Frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
    • The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning

Secondary Measures

  • Short-term change in “letter memory running span task”
    • Time Frame: Week 12 and 24
    • A measure of the updating functioning
  • Long-term change in “letter memory running span task”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
    • A measure of the updating functioning
  • Short-term change in “3-back task”
    • Time Frame: Week 12 and 24
    • A measure of the updating functioning
  • Long-term change in “3-back task”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
    • A measure of the updating functioning
  • Short-term change in the “colour word interference test (the Stroop test)”
    • Time Frame: Week 12 and 24
    • A measure of the inhibition functioning, from D-KEFS
  • Long-term change in the “colour word interference test (the Stroop test)”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of the inhibition functioning, from D-KEFS
  • Short-term change in the “trail making test”
    • Time Frame: Week 12 and 24
    • A measure of attentional shifting, from D-KEFS
  • Long-term change in the “trail making test”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of attentional shifting, from D-KEFS
  • Short-term change in the “digit span forward test”
    • Time Frame: Week 12 and 24
    • A measure of the working memory, from WAIS-R
  • Long-term change in the “digit span forward test”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of the working memory, from WAIS-R
  • Short-term change in the “digit span backward test”
    • Time Frame: Week 12 and 24
    • A measure of the working memory, from WAIS-R
  • Long-term change in the “digit span backward test”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of the working memory, from WAIS-R
  • Short-term change in the “letter-number sequencing” test
    • Time Frame: Week 12 and 24
    • A measure of the working memory, from WAIS-III
  • Long-term change in the “letter-number sequencing” test
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of the working memory, from WAIS-III
  • Short-term change in the “recall of concrete nouns” test (Buschke’s selective reminding procedure)
    • Time Frame: Week 12 and 24
    • A measure of the episodic memory
  • Long-term change in the “recall of concrete nouns” test (Buschke’s selective reminding procedure)
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of the episodic memory
  • Short-term change in the “digit symbol” test
    • Time Frame: Week 12 and 24
    • A measure of perceptual speed, from WAIS-R
  • Long-term change in the “digit symbol” test
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of perceptual speed, from WAIS-R
  • Short-term change in “Raven’s advanced progressive matrices”
    • Time Frame: Week 12 and 24
    • A measure of non-verbal reasoning ability
  • Long-term change in “Raven’s advanced progressive matrices”
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of non-verbal reasoning ability
  • Short-term change in Shirom Melamed Burnout Questionnaire
    • Time Frame: Week 12 and 24
    • A burnout measure
  • Long-term change in Shirom Melamed Burnout Questionnaire
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A burnout measure
  • Short-term change in Short Form 36 item Health Questionnaire
    • Time Frame: Week 12 and 24
    • Health-related quality of life estimate
  • Long-term change in Short Form 36 item Health Questionnaire
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • Health-related quality of life estimate
  • Short-term change in Checklist Individual Strength Questionnaire
    • Time Frame: Week 12 and 24
    • Measure of fatigue
  • Long-term change in Checklist Individual Strength Questionnaire
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • Measure of fatigue
  • Short-term change in Hospital Anxiety and Depression Scale, HAD-S
    • Time Frame: Week 12 and 24
    • A measure of anxiety and depression
  • Long-term change in Hospital Anxiety and Depression Scale, HAD-S
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A measure of anxiety and depression
  • Short-term change in aerobic capacity
    • Time Frame: Week 12 and 24
    • A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
  • Long-term change in aerobic capacity
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
  • Short-term change in work ability
    • Time Frame: Week 12 and 24
    • Work Ability Index questionnaire, short version
  • Long-term change in work ability
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • Work Ability Index questionnaire, short version
  • Long-term total sick leave change
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • Information about sick leave from registers at the Social Insurance Agency in Sweden
  • Long-term cost-effectiveness
    • Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
    • Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Umeå University
  • Collaborator
    • Västerbotten County Council, Sweden
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lisbeth Slunga Järvholm, MD, Ass Prof, Principal Investigator, Umeå University

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