Condition category
Mental and Behavioural Disorders
Date applied
30/04/2020
Date assigned
19/05/2020
Last edited
19/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Burnout, which is characterized by high levels of exhaustion and a cynical attitude towards work, represents a serious health concern for employees. Previous studies have identified issues with psychological detachment from work as one of the important antecedents of this occupational phenomenon. More specifically, thinking about work and being engaged in work-related behaviors during off-job time (especially when such thoughts and behaviors are perceived as negative and intrusive) leads to increased burnout. However, it is still unclear how such problematic engagement in work during off-job time and burnout can be prevented and, especially, what the underlying mechanisms of change are.
The aim of this study is to, first, compare the effectiveness of two interventions that have previously been identified as helpful in the context of work-home boundary management and/or burnout, namely cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR). Second, the study aims to investigate whether work-related maladaptive thinking patterns (i.e. inflexible, unreasonable, and negatively valenced cognitions that may lead to higher work-home integration and, in the next step, burnout) operate as mechanisms of change in work-home boundary management and burnout.

Who can participate?
Anyone aged 18 or above who is willing to commit at least 2 hours per week to the intervention, is currently employed and works at least 40 hours per week and is currently not involved in other psychological therapies is welcome to participate in the prescreening part of the study. Only participants who display at least moderate levels of burnout and report having some issues with psychologically detaching from work will then be invited to participate in the main part of the study (interventions).

What does the study involve?
Participants will be randomly allocated to the CBT intervention, MBSR intervention or to the waitlist control group (the latter will be invited to participate in either of the two interventions after the end of the study). Both interventions will take place online, last for 6 weeks and consist of two audio-guided active sessions per week (about 30 minutes each) and homework (about 1 hour per week). In the first active session (week 1), all participants will fill in questionnaires that measure burnout, psychological detachment, maladaptive thinking patterns and other related constructs (e.g. depression, sleep quality), They will be asked to fill in these questionnaires once more during the last active session (week 6) and 3 months after the intervention.

What are the possible benefits and risks of participating?
Although the researchers cannot guarantee that the prepared interventions will help all participants, it is hoped that taking part in both interventions (CBT or MBSR) will reduce burnout levels as well as negative aspects of work-home integration and work-related maladaptive thinking patterns. Additionally, the results of this study will help researchers to understand how continuous cognitive, behavioral, and emotional engagement in work during off-job time as well as burnout can be decreased and potentially prevented. The researchers do not foresee any potential for significant distress or adverse events, but they do acknowledge that slight discomfort in earlier stages of the interventions is possible (due to, for example, participants in the CBT intervention paying more attention to negative work-related thoughts so they can practice challenging them). Participants who will feel distressed for any reason will be able to contact researchers immediately and get individualized support.

Where is the study run from?
1. University of Maribor (Slovenia)
2. Andrej Marušič Institute (Slovenia)

When is the study starting and how long is it expected to run for?
February 2020 to February 2021

Who is funding the study?
Slovenian Research Agency — ARRS

Who is the main contact?
1. Dr Sara Tement
sara.tement@um.si
2. Nejc Plohl
nejc.plohl1@um.si

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sara Tement

ORCID ID

http://orcid.org/0000-0002-3442-5643

Contact details

Koroška cesta 160
Maribor
2000
Slovenia
+386 (0)2 229 3855
sara.tement@um.si

Type

Scientific

Additional contact

Mr Nejc Plohl

ORCID ID

http://orcid.org/0000-0001-9936-4039

Contact details

Koroška cesta 160
Maribor
2000
Slovenia
+386 (0)2 229 3855
nejc.plohl1@um.si

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A randomized controlled trial to improve psychological detachment from work and well-being among employees: comparing online CBT- and mindfulness-based interventions

Acronym

Study hypothesis

H1: The CBT intervention will lead to lower levels of work-related maladaptive thinking patterns directly after the intervention (T2) and at follow-up (T3) compared to levels prior to the intervention (T1) and to mindfulness and control groups.
H2: The CBT intervention will lead to higher levels of psychological detachment from work directly after the intervention (T2) and at follow-up (T3) compared to levels prior to the intervention (T1) and to mindfulness and control groups.
H3: The CBT intervention will lead to lower levels of burnout directly after the intervention (T2) and at follow-up (T3) compared to levels prior to the intervention (T1) and to mindfulness and control groups.
H4: The MSBR intervention will lead to lower levels of burnout directly after the intervention (T2) and at follow-up (T3) compared to levels prior to the intervention (T1) and to the control group.
H5: Work-related maladaptive thinking patterns act as a mechanism through which the interventions will contribute to higher psychological detachment from work.
H6: Work-related maladaptive thinking patterns act as a mechanism through which the interventions will contribute to lower burnout.

Ethics approval

Approval pending, Institutional Review Board of the Faculty of Arts (University of Maribor, Slovenia; kerff@um.si)

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Burnout (and well-being of employees in general)

Intervention

The intervention will consist of two treatments (cognitive-behavioral therapy and mindfulness-based stress reduction) and a waitlist control group.

Both interventions will take place online and last for 6 weeks, with two active sessions per week (accompanied by an equal amount of homework).

Block randomization (based on demographical data) will be used. Participants will be blinded to the intervention they were allocated to (both interventions will be advertised as occupational stress-reduction interventions) and control group participants will not be aware that they are part of the control group.

Outcomes will be assessed before the intervention (T1), directly after the intervention (T2) and at follow-up approximately 3 months later (T3).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Burnout measured with the Maslach Burnout Inventory - General Survey at baseline, immediately after the intervention, and 3 months after the intervention

Secondary outcome measures

All measured at baseline, immediately after the intervention, and 3 months after the intervention:
1. Psychological detachment measured with the Recovery Experience Questionnaire and a self-developed Work-home integration questionnaire
2. Sleep quality and disturbances measured with The Pittsburgh Sleep Quality Index
3. Depression, anxiety and stress measured with the Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

Other measures (mechanisms rather than outcomes):
1. Work-related maladaptive thinking patterns measured with the Work-related maladaptive thinking patterns questionnaire
2. Mindfulness measured with the Five Facet Mindfulness Questionnaire

Overall trial start date

24/02/2020

Overall trial end date

01/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or above
2. Willing to commit at least 2 hours per week to the intervention
3. Currently employed and work at least 40 hours per week
4. Currently not be involved in other psychological therapies

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Approximately 141 completely eligible participants will be recruited (47 participants in each of the three conditions).

Participant exclusion criteria

Participants who do not display at least moderate levels of burnout and who do not report any problems with psychological detachment from work

Recruitment start date

01/07/2020

Recruitment end date

01/10/2020

Locations

Countries of recruitment

Slovenia

Trial participating centre

University of Maribor
Department of Psychology Faculty of Arts Koroška cesta 160
Maribor
2000
Slovenia

Trial participating centre

Andrej Marušič Institute, University of Primorska
Muzejski trg 2
Koper
6000
Slovenia

Sponsor information

Organisation

University of Maribor

Sponsor details

Department of Psychology
Faculty of Arts
Koroška cesta 160
Maribor
2000
Slovenia
+386 (0)2 229 3855
psihologija@um.si

Sponsor type

University/education

Website

http://www.ff.um.si/oddelki/psihologija/

Funders

Funder type

Research organisation

Funder name

Slovenian Research Agency — ARRS (Grant J5-9449)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to publish a detailed study protocol in 2020 and an empirical article with results in 2021. These publications will be accompanied by presentations at international scientific conferences. The main findings will also be communicated to practitioners and the general public using social media and news outlets.

IPD sharing statement
Participant level data can be retrieved by contacting Dr Sara Tement (sara.tement@um.si). The researchers are willing to share anonymized raw data with researchers for the use in meta-analyses (with no time restriction). They are not willing to share data for commercial purposes under any circumstances. They would also like to note that participants will be made aware of how the data will be used, stored and shared in the informed consent form and they will also be able to withdraw their data up to one year after the study has ended (by stating their participant ID).

Intention to publish date

01/10/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/05/2020: Trial's existence confirmed by SICRIS (Slovenian Current Research Information System).