NCT03073772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
Last Updated

March 8, 2017

Status Verified

February 1, 2017

Enrollment Period

4.8 years

First QC Date

February 22, 2017

Last Update Submit

March 2, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (34)

  • Short-term change in "letter memory running span task"

    Week 12 and 24

  • Long-term change in "letter memory running span task"

    Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects

  • Short-term change in "3-back task"

    Week 12 and 24

  • Long-term change in "3-back task"

    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)"

    Week 12 and 24

  • +29 more secondary outcomes

Study Arms (3)

Continued multimodal rehabilitation

NO INTERVENTION

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

Computer-based cognitive training

ACTIVE COMPARATOR

This arm also consisted of continued multimodal rehabilitation.

Behavioral: Computer-based cognitive training

Physical fitness training

ACTIVE COMPARATOR

This arm also consisted of continued multimodal rehabilitation.

Behavioral: Physical fitness training

Interventions

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.

Computer-based cognitive 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.

Physical fitness training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
  • years of age
  • Current employment
  • Considered suitable for multimodal rehabilitation in group

You may not qualify if:

  • Need of other treatment or rehabilitation
  • Abuse of alcohol or drugs
  • Participation in another intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council

Umeå, 90333, Sweden

Location

Related Publications (4)

  • Nelson A, Aronsson I, Tillfors M, Neely AS, Gavelin HM. The experienced route to cognitive health: Cognitive recovery in persons with prior stress-related Exhaustion disorder. BMC Psychiatry. 2025 Apr 14;25(1):375. doi: 10.1186/s12888-025-06713-7.

  • 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.

MeSH Terms

Conditions

SyndromeBurnout, Psychological

Condition Hierarchy (Ancestors)

DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Lisbeth Slunga Järvholm, MD, Ass Prof

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 8, 2017

Study Start

April 1, 2010

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

March 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations