Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals

January 11, 2021 updated by: Universidad Nacional de Educación a Distancia

Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals: a Randomized Controlled Trial

The aim of this study is to examine the effectiveness of two mindfulness interventions for stress, anxiety and burnout in mental health professionals. Participants will receive the treatments in reverse order: a brief intervention based on body-centered exercises and another brief intervention based on sitting meditation. It is hypothesized that both interventions will decrease stress and anxiety levels and professional burnout, with mindfulness body-centered exercises being at least as effective as mindfulness meditations.

Study Overview

Status

Status

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

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

The aim of this study is to examine the effectiveness of two mindfulness interventions for stress, anxiety and burnout in mental health professionals. It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA. Treatment A consists of a block of five sessions of bodyfulness exercises, whereas experimental treatment B consists of a block of five sessions of sitting mindfulness meditation exercises. In the sixth session, the exercise blocks will be exchanged. Each group will be composed of half the sample, with a initial sample of 130. The principal hypothesis is that both interventions will decrease stress and anxiety levels and professional burnout, with body-centered exercises being at least as effective as mindfulness sitting meditations. Secondarily, the personality type will be analyzed as a moderating variable in those variables in which the interventions will be effective. Third, a qualitative study will be conducted in order to analyze the perceptions of change and experiences in Cuban mental health professionals who are beginner meditators. This study will allow to understand the differential effectiveness of bodyfulness and midfulness and what types of personality may benefit most from different types of meditation interventions. Also, it will hell to get a deeper understanding of mindfulness practice in a new cultural context (i.e., Cuba). A previous pilot study will be conduct to investigate the acceptability and effectiveness of a culturally-adapted mindfulness-based intervention in Cuba.

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 (Actual)

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.
127

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

  • Cuba
      • La Habana, Cuba
        • Justo Reinalod Fabelo Roche

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be a full time mental health professional
  • To be 18 years or older
  • To be able to attend weekly sessions

Exclusion Criteria:

  • To suffer a pathology that discourages participation in the study.
  • Previous training in mindfulness

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: Crossover Assignment
  • Masking: Double

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: Course A
Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
Behavioral: Sitting Mindfulness Exercises.
5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
Behavioral: Body Mindfulness Exercises
5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements
Experimental: Course B
Sitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
Behavioral: Sitting Mindfulness Exercises.
5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
Behavioral: Body Mindfulness Exercises
5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements

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
Change from Baseline Stress at 5 weeks
Time Frame: Baseline, Post- treatment 5 weeks from baseline
Stress measured using Seppo Aro Symptomatic Stress Scale
Baseline, Post- treatment 5 weeks from baseline
Change from Baseline Burnout at 5 weeks
Time Frame: Baseline, Post- treatment 5 weeks from baseline
Burnout measured using Moreno Short Questionnaire of Burnout.
Baseline, Post- treatment 5 weeks from baseline
Change from Baseline Stress at 10 weeks
Time Frame: Baseline, Post- treatment 10 weeks
Stress measured using Seppo Aro Symptomatic Stress Scale
Baseline, Post- treatment 10 weeks
Change from Baseline Stress at three-months follow-up
Time Frame: Baseline, Three-months follow-up
Stress measured using Seppo Aro Symptomatic Stress Scale
Baseline, Three-months follow-up
Change from Baseline Burnout at 10 weeks
Time Frame: Baseline, Post- treatment 10 weeks
Burnout measured using Moreno Short Questionnaire of Burnout.
Baseline, Post- treatment 10 weeks
Change from Baseline Burnout at at three-months follow-up
Time Frame: Baseline, Three-months follow-up
Burnout measured using Moreno Short Questionnaire of Burnout.
Baseline, Three-months follow-up
Change from Baseline State Anxiety at 5 weeks
Time Frame: Baseline, Post- treatment 5 weeks from baseline
State anxiety measured using State Anxiety Inventary IDARE
Baseline, Post- treatment 5 weeks from baseline
Change from Baseline State Anxiety at 10 weeks
Time Frame: Baseline, Post- treatment 10 weeks
State anxiety measured using State Anxiety Inventary IDARE
Baseline, Post- treatment 10 weeks
Change from Baseline State Anxiety at three-months follow-up
Time Frame: Baseline, Three-months follow-up
State anxiety measured using State Anxiety Inventary IDARE
Baseline, Three-months follow-up

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
Sociodemographic data
Time Frame: Baseline
Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.
Baseline
The sixteen personality factor questionnaire
Time Frame: Baseline
Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.
Baseline

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.
Universidad Nacional de Educación a Distancia

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.
Universidad de Ciencias Médicas de La Habana

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.
  • Study Director: Miguel Angel Santed Germán, PhD, Universidad Nacional a Distancia (España)
  • Study Chair: Justo R Fabelo Roche, PhD, Universidad de Ciencias Médicas de La Habana (Cuba)

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.

General Publications

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 (Actual)

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.
January 22, 2018

Primary Completion (Actual)

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.
May 22, 2018

Study Completion (Actual)

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.
January 7, 2019

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).
September 18, 2017

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.
September 27, 2017

First Posted (Actual)

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.
September 28, 2017

Study Record Updates

Last Update Posted (Actual)

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.
January 14, 2021

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.
January 11, 2021

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.
January 1, 2021

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.
  • 48817036RRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study are available from the corresponding author, [Miguel A. Santed], upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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