Condition category
Mental and Behavioural Disorders
Date applied
04/03/2014
Date assigned
25/06/2014
Last edited
25/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Gloster

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of acceptance and commitment therapy (ACT) self-help for burnout: a randomized controlled trial

Acronym

Study hypothesis

Participants 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

Regional ethics committee Ethikkommission beider Basel (EKBB), 10/07/2013, ref: EK 336/12

Study design

Randomized controlled wait-list trial with three groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Burnout is a syndrome consisting of three dimensions: overwhelming exhaustion, feelings of cynicism and detachment, and subjective sense of ineffectiveness/lack of accomplishment.

Intervention

The 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The 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 measures

1. 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 trial start date

05/11/2013

Overall trial end date

31/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

1. 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

Recruitment start date

05/11/2013

Recruitment end date

31/10/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Missionsstrasse 62a
Basel
4055
Switzerland

Sponsor information

Organisation

University of Basel (Switzerland)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes