ISRCTN ISRCTN96695189
DOI https://doi.org/10.1186/ISRCTN96695189
Secondary identifying numbers N/A
Submission date
04/03/2014
Registration date
25/06/2014
Last edited
03/06/2020
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

Plain English summary of protocol

Background and study aims
Burnout has been observed globally and is associated with numerous negative consequences ranging from depression, anxiety, low levels of self-esteem and well-being to decreased job performance and job turnover. Acceptance and commitment therapy (ACT) may be helpful to reduce burnout-associated suffering. Individual therapy – especially ACT – is not always feasible, available, or accessible. Self-help books may be possible alternatives. However, these need to be tested rigorously before they can be used as part of a wider health-care framework. Therefore, this study aims to find out the effectiveness of a self-help book for burnout-based on ACT without any therapist contact by using an exclusively online platform.

Who can participate?
Adults who are shown to have moderate levels of stress can take part in this study.

What does the study involve?
Participants are randomly allocated to one of three groups. First groups get the self-help book immediately. The second and third group receive the book after a waiting period of 6 weeks, with or without assessments respectively during that period. Participants receive a copy of a self-help book for dealing with burnout from an ACT perspective. Upon receiving the book, they log into the online assessment platform. Participants complete online questions before reading the book, after every chapter, immediately after finishing the book, and 3 months after reading the book. As described in the chapters of the book, participants are encouraged to apply and exercise concepts discussed in the book.

What are the possible benefits and risks of participating?
Participants can potentially benefit by reducing suffering surrounding burnout symptoms. Potential risks include disappointment of not improving or temporary discomfort surrounding an exercise discussed in the book.

Where is the study run from?
The study is carried out in the participants homes.

When is the study starting and how long is it expected to run for?
The study started in November 2013 and runs until October 2014.

Who is funding the study?
Investigator initiated and funded (Switzerland)

Who is the main contact?
Dr Andrew Gloster
andrew.gloster@unibas.ch

Contact information

Dr Andrew Gloster
Scientific

Missionsstrasse 62a
University of Basel
Department of Psychology
Basel
4055
Switzerland

Study information

Study designRandomized controlled wait-list trial with three groups
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffectiveness of acceptance and commitment therapy (ACT) self-help for burnout: a randomized controlled trial
Study objectivesParticipants engaging with the ACT self-help book will have significantly greater pre-post improvement in perceived stress and burnout symptoms than the wait-list groups.
Ethics approval(s)Regional ethics committee Ethikkommission beider Basel (EKBB), 10/07/2013, ref: EK 336/12
Health condition(s) or problem(s) studiedBurnout is a syndrome consisting of three dimensions: overwhelming exhaustion, feelings of cynicism and detachment, and subjective sense of ineffectiveness/lack of accomplishment.
InterventionThe self-help book 'ACT gegen Burnout' by Michael Waadt and Jens Acker. The book presents principles and techniques derived from Acceptance and Commitment Therapy (ACT). No additional therapeutic contact is provided.

The study is a randomized, wait-list controlled clinical trial. All assessments occur exclusively online and are measured at pretreatment, post-treatment, 3-month follow-up, and during the time that the participants are working through the self-help book.

Randomization will made to one of three groups:
1. Immediate ACT self-help book condition
2. A 6-week wait-list with weekly assessments during the waiting period
3. A 6-week wait-list without weekly assessments during the waiting period.
Intervention typeOther
Primary outcome measureThe primary symptom-based outcome measures will be:
1. The Perceived Stress Scale (PSS)
2. The Maslach Burnout Inventory - General Survey (MBI-GS)
Outcomes will be measured at baseline, post-treatment, and at 3-month follow-up.
Secondary outcome measures1. Depression
2. Psychological flexibility
3. Process of psychological flexibility
4. Cognitive fusion
5. Mindfulness
6. Emotion regulation
7. Problematic emotion regulation
8. Flourishing mental health/well-being
9. Values
10. Comprehension
Outcomes will be measured at baseline, post-treatment, and at 3-month follow-up.
Overall study start date05/11/2013
Completion date31/10/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants128
Total final enrolment119
Key inclusion criteria1. 18-65 years of age
2. Perceived Stress Scale (PSS) score greater than or equal to 17 (at least moderate levels of perceived stress)
3. No active current suicidal intent (as measured by the BDI-II suicide item no. 9 less than or equal to 1)
Key exclusion criteria1. Less than 18 or over 65 years of age
2. Perceived Stress Scale (PSS) score less than 17
3. Current suicidal intent (as measured by the BDI-II suicide item no. 9 greater than 1)
4. Current psychotherapy
Date of first enrolment05/11/2013
Date of final enrolment31/10/2014

Locations

Countries of recruitment

  • Germany
  • Switzerland

Study participating centre

Missionsstrasse 62a
Basel
4055
Switzerland

Sponsor information

University of Basel (Switzerland)
University/education

c/o Dr Andrew Gloster
Missionsstrasse 62a
University of Basel
Department of Psychology
Basel
4055
Switzerland

ROR logo "ROR" https://ror.org/02s6k3f65

Funders

Funder type

Other

Investigator initiated and funded (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/11/2017 03/06/2020 Yes No

Editorial Notes

03/06/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.