Improving psychological detachment from work and well-being with online cognitive-behavioral therapy and mindfulness

ISRCTN ISRCTN98347361
DOI https://doi.org/10.1186/ISRCTN98347361
Submission date
30/04/2020
Registration date
19/05/2020
Last edited
08/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 June 2022 (updated 09/09/2021, previously: January 2022; updated 05/07/2021, previously: October 2021; updated 05/01/2021, previously: May 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

Contact information

Dr Sara Tement
Scientific

Koroška cesta 160
Maribor
2000
Slovenia

ORCiD logoORCID ID 0000-0002-3442-5643
Phone +386 (0)2 229 3855
Email sara.tement@um.si
Mr Nejc Plohl
Scientific

Koroška cesta 160
Maribor
2000
Slovenia

ORCiD logoORCID ID 0000-0001-9936-4039
Phone +386 (0)2 229 3855
Email nejc.plohl1@um.si

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleA randomized controlled trial to improve psychological detachment from work and well-being among employees: comparing online CBT- and mindfulness-based interventions
Study objectivesH1: 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(s)Approved 29/06/2020, Institutional Review Board of the Faculty of Arts (University of Maribor, Koroška cesta 160, 2000 Maribor, Slovenia; +386 2 22 93 840; kerff@um.si), ref: 038-7-63/2020/5/FFUM
Health condition(s) or problem(s) studiedBurnout (and well-being of employees in general)
InterventionThe 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 typeBehavioural
Primary outcome measureCurrent primary outcome measures as of 28/09/2020:
All measured at baseline, immediately after the intervention and 3 months after the intervention:
1. Burnout measured with the Maslach Burnout Inventory – General Survey
2. Psychological detachment measured with the Recovery Experience Questionnaire

Previous primary outcome measures:
Burnout measured with the Maslach Burnout Inventory - General Survey at baseline, immediately after the intervention, and 3 months after the intervention
Secondary outcome measuresCurrent secondary outcome measures as of 28/09/2020:
All measured at baseline, immediately after the intervention, and 3 months after the intervention:
1. Quality of sleep measured with The Pittsburgh Sleep Quality Index
2. Work engagement measured with the Utrecht Work Engagement Scale
3. Workaholism measured with the Dutch Workaholism Scale
4. Work-family conflict measured with the Work-Family Conflict Scale
5. Positive and negative affect measured with the International Positive and Negative Affect Schedule Short Form
6. Life satisfaction measured with the Satisfaction With Life Scale
7. Depression, anxiety and stress measured with The Depression, Anxiety and Stress Scale – 21 Items

Other measures (potential mechanisms of change and moderators rather than outcomes):
1. Mindfulness measured with the Mindfulness Attention and Awareness Scale
2. Work-related maladaptive thinking patterns measured with the Work-Related Maladaptive Thinking Patterns Questionnaire
3. Supervisor support for recovery measured with the Supervisor Support for Recovery Scale
4. Work-home segmentation measured with the Segmentation Supplies Scale
5. Unfinished tasks measured with items developed by Syrek and colleagues (2016)
6. Time pressure measured with the Instrument for Stress-Related Job Analysis subscale
7. Background variables

Previous 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 study start date24/02/2020
Completion date30/06/2022

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsApproximately 151 completely eligible participants will be recruited (about 50 participants in each of the three conditions)
Key inclusion criteria1. 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
Key exclusion criteriaParticipants who do not display at least moderate levels of burnout and who do not report any problems with psychological detachment from work
Date of first enrolment01/08/2020
Date of final enrolment31/01/2022

Locations

Countries of recruitment

  • Slovenia

Study participating centres

University of Maribor
Department of Psychology
Faculty of Arts
Koroška cesta 160
Maribor
2000
Slovenia
Andrej Marušič Institute, University of Primorska
Muzejski trg 2
Koper
6000
Slovenia

Sponsor information

University of Maribor
University/education

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

Phone +386 (0)2 229 3855
Email psihologija@um.si
Website http://www.ff.um.si/oddelki/psihologija/
ROR logo "ROR" https://ror.org/01d5jce07

Funders

Funder type

Research organisation

Slovenian Research Agency — ARRS (Grant J5-9449)

No information available

Results and Publications

Intention to publish date31/12/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planParticipant 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).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 16/11/2020 05/01/2021 Yes No
Protocol article protocol 16/11/2020 05/01/2021 Yes No

Editorial Notes

08/12/2022: The intention to publish date was changed from 31/12/2022 to 31/12/2023.
09/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 10/09/2021 to 31/01/2022.
2. The overall trial end date has been changed from 31/01/2022 to 30/06/2022 and the plain English summary has been updated to reflect this change.
05/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 10/09/2021.
2. The overall trial end date has been changed from 31/10/2021 to 31/01/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/10/2021 to 31/12/2022.
05/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 11/01/2021 to 30/06/2021.
2. The overall end date was changed from 27/05/2021 to 31/10/2021.
3. Publication reference added.
4. The plain English summary was updated to reflect these changes.
28/09/2020: The following changes were made to the trial record:
1. The primary and secondary outcome measures were updated.
2. The target number of participants was changed from 'Approximately 141 completely eligible participants will be recruited (47 participants in each of the three conditions)' to 'Approximately 151 completely eligible participants will be recruited (about 50 participants in each of the three conditions)'.
3. The recruitment end date was changed from 01/10/2020 to 11/01/2021.
4. The overall trial end date was changed from 01/02/2021 to 27/05/2021.
27/07/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/07/2020 to 01/08/2020.
2. The ethics approval was added.
01/05/2020: Trial's existence confirmed by SICRIS (Slovenian Current Research Information System).