The Effectiveness of Mindfulness Practices in the Recovery of Burnout (Muupu)

December 1, 2015 updated by: University of Jyvaskyla
The aim of this study is to examine the effectiveness of intervention based on mindfulness and acceptance-commitment therapy (ACT) in the recovery from job burnout. The 8-week intervention is delivered using jointly face-to-face group meetings and web-based program. The study hypothesizes that the Muupu-program is more effective than the normal practices when promoting work well-being in Finland. The participants are recruited from Finland.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mindfulness-ACT-based interventions aren't widely used in Finnish work health care a the moment. This study examines the possibility of using this kind of intervention for reducing job burnout and stress and also promoting well-being at work. Muupu-program is standardized and can be administered in varying settings. If intervention is effective, it can have an impact on Finnish practices when treating job burnout and work-related stress.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, 40014
        • University of Jyväskylä, Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently working
  • Daily internet connection available
  • Belongs to the group of most exhausted workers in Finland (BBI cut-off is set on the top 25%)

Exclusion Criteria:

  • No psychological or somatic conditions or other practical reasons that hinder the possibility to participate to the program
  • Acute medicine changes
  • Regular psychotherapy
  • Not willing to inform employer and/or work health care of participation to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mindfulness-ACT-intervention
Group meetings face-to-face and web-based program using principles of mindfulness and ACT.
Behavioral: Mindfulness-ACT-intervention
Half of the participants (n=109) is assigned to intervention group. The intervention is based on Mindfulness-program presented by Williams & Penman (2011) and on principles of acceptance-commitment therapy (ACT). It aims to increase mindfulness skills and psychological flexibility through different exercises that are developed for improving skills of being present, dealing with thoughts and feelings as well as support clarifying individual values and value-based actions. The basic principles are presented in weekly small group meetings. Participants are guided to deepen their experiences through exercises and information that is provided via specific web-site.
EXPERIMENTAL: Control
Control group, no intervention.
Behavioral: No intervention
Half of the participants (n=109) don't get any special treatment. However the present study explores what kind of support they have had during the program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bergen Burnout Indicator (BBI)
Time Frame: Change from baseline burnout at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline burnout at 2, 6 and 12 months
Perceived Stress Scale (PSS)
Time Frame: Change from baseline stress at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline stress at 2, 6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Change from baseline mindfulness at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline mindfulness at 2, 6 and 12 months
Acceptance and Action Questionnaire (AAQ-II)
Time Frame: Change from baseline psychological flexibility at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline psychological flexibility at 2, 6 and 12 months
Automatic Thought Questionnaire (ATQ)
Time Frame: Change from baseline automatic thoughts at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline automatic thoughts at 2, 6 and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utrecht Work Engagement Scale (UWES)
Time Frame: Change from baseline work engagement at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline work engagement at 2, 6 and 12 months
Working conditions questionnaires used in Finlad
Time Frame: Change from baseline working conditions at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline working conditions at 2, 6 and 12 months
Depression, Anxiety and Stress Questionnaire (DASS)
Time Frame: Change from baseline depression, anxiety and sress at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline depression, anxiety and sress at 2, 6 and 12 months
Psychological Well-being (by Ryff)
Time Frame: Change from baseline psychological well-being at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline psychological well-being at 2, 6 and 12 months
Life Situation Questionnaire (LSQ, by Pulkkinen)
Time Frame: Change from baseline life situation at 2, 6 and 12 months
Study has 4 time points when the same questionnaires are administered to assess possible changes in outcome measures.
Change from baseline life situation at 2, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jyvaskyla

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Finnish Social Insurance Institution

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne M Puolakanaho, PhD, University of Jyväskylä, Department of Psychology
  • Principal Investigator: Raimo Lappalainen, PhD, University of Jyväskylä, Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21000021201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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