Managing burnout with non-invasive neuromodulation
| ISRCTN | ISRCTN94275121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94275121 |
| Secondary identifying numbers | tDCS_burnout |
- Submission date
- 13/11/2019
- Registration date
- 18/12/2019
- Last edited
- 03/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Burnout is a state of emotional, physical, and mental exhaustion caused by excessive and prolonged stress. Burnout is characterized by deficiencies in attention and several components of the working memory, of which the lingering effects of impaired attention and executive functions are the most frustrating
Who can participate?
Patients aged 18 years or above with a score of > 4 on the Dutch version of the Maslach Burnout Scale (MBS)
What does the study involve?
Patients with burnout received three weeks of daily sessions (15 sessions in total) of atDCS or sham stimulation in addition to three weekly sessions of standard behavioral therapy
What are the possible benefits and risks of participating?
Potential benefits for the participants in the real tDCS group will be that their attention skills will be improved much quicker than those of the participants in the sham group. Behaviorally, no negative effects of tDCS have been registered yet. However, temporary skin irritation, headaches, nausea, dizziness, exhaustion, and visual deficits have been reported.
Where is the study run from?
DIADIS NV, Belgium
When is the study starting and how long is it expected to run for?
February 2016 to May 2017
Who is funding the study?
Fonds Wetenschappelijk Onderzoek, Belgium
Who is the main contact?
Dr Kim van Dun
kim.vandun@uhasselt.be
Contact information
Public
Agoralaan A
Diepenbeek
3590
Belgium
 ORCID ID |
0000-0002-5212-8650 |
|---|---|
| Phone | +32496732633 |
| kim.vandun@uhasselt.be |
Scientific
Agoralaan A
Diepenbeek
3590
Belgium
| Phone | +32496732633 |
|---|---|
| kim.vandun@uhasselt.be |
Study information
| Study design | Randomized single centre blinded sham-controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a participant information sheet |
| Scientific title | Transcranial direct current stimulation and attention skills in burnout patients: a randomized blinded sham-controlled pilot study |
| Study hypothesis | Anodal transcranial direct current stimulation (atDCS) over the left dorsolateral prefrontal cortex (DLPFC) can improve the executive control of attention and possibly also several other components of working memory in patients with burnout |
| Ethics approval(s) | Approved 05/11/2014, Commissie Medische Ethiek Vrije Universiteit Brussel (Laarbeeklaan 1090 Brussels, Belgium; +32 24775584; commissie.ethiek@uzbrussel.be), ref: B.U.N. 143201422009 |
| Condition | Attention deficits in burnout |
| Intervention | Real tDCS: daily sessions for 3 weeks, 1 session consisted of 2mA, 20min, anodal tDCS over the left dorsolateral prefrontal cortex (cathode over lateral aspect of contralateral orbit) + 1 session / week of behavioral therapy Sham tDCS: daily sessions for 3 weeks, 1 session consisted of 2mA, 1min, anodal tDCS over the left dorsolateral prefrontal cortex (cathode over lateral aspect of contralateral orbit) + 1 session / week of behavioral therapy Randomisation: |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Attention measured using RBANS at baseline and after 3 weeks of stimulation |
| Secondary outcome measures | At baseline and after 3 weeks of stimulation: 1. Burnout measured using MBS 2. Depression measured using BDI 3. Quality of Life measured using QoL 4. Attention measured using RBANS Attention Index 5. Vigilance measured using D2 (s-score) 6. Central executive measured using Inhibition and shifting, Stroop III, TMT B, WCST 7. Processing speed (updating and control) measured using TMT A, Stroop I and II, D2 (Gz, F%, Gz – F) 8. Phonological loop measured using RBANS Language Index 9. BNTmeasured using Semantic fluency tasks 10. Visuospatial sketchpad measured using Raven and RBANS Visuospatial Index 11. Encoding measured using RBANS Immediate Memory Index 12. Retrieval measured using RBANS Recent Memory Index |
| Overall study start date | 21/05/2014 |
| Overall study end date | 22/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 16 |
| Participant inclusion criteria | 1. Score of > 4 on the Dutch version of the Maslach Burnout Scale (MBS) |
| Participant exclusion criteria | 1. Excessive drug or alcohol use 2. Epilepsy 3. Depression 4. Bipolar syndrome 5. Chronic fatigue syndrome or any other history of psychiatric or neurological disorders 6. Implanted neurostimulator or pace-maker 7. Drugs interacting directly with the NMDA receptors 8. Pregnancy |
| Recruitment start date | 08/02/2016 |
| Recruitment end date | 01/05/2017 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Oud-Turnhout
2360
Belgium
Sponsor information
University/education
Pleinlaan 5
Brussel
1050
Belgium
| Phone | 003226292010 |
|---|---|
| info@vub.ac.be | |
| Website | https://www.vub.be |
"ROR" |
https://ror.org/006e5kg04 |
Government
Egmontstraat 5
Brussel
1000
Belgium
| Phone | 003225129110 |
|---|---|
| post@fwo.be | |
| Website | http://www.fwo.be |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Research Foundation Flanders, Flemish Research Foundation, FWO
- Location
- Belgium
Results and Publications
| Intention to publish date | 25/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | PLOS One |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | results in preprint | 14/02/2020 | 03/06/2020 | No | No |
Editorial Notes
03/06/2020: The following changes have been made:
1. Preprint reference added.
2. The final enrolment number has been added from the reference.
15/11/2019: Trial’s existence confirmed by Commissie Medische Ethiek Vrije Universiteit Brussel
