<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296254</url>
  </required_header>
  <id_info>
    <org_study_id>48817036RRI</org_study_id>
    <nct_id>NCT03296254</nct_id>
  </id_info>
  <brief_title>Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals</brief_title>
  <official_title>Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Educación a Distancia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de Ciencias Médicas de La Habana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Nacional de Educación a Distancia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the effectiveness of two mindfulness interventions for&#xD;
      stress, anxiety and burnout in mental health professionals. Participants will receive the&#xD;
      treatments in reverse order: a brief intervention based on body-centered exercises and&#xD;
      another brief intervention based on sitting meditation. It is hypothesized that both&#xD;
      interventions will decrease stress and anxiety levels and professional burnout, with&#xD;
      mindfulness body-centered exercises being at least as effective as mindfulness meditations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to examine the effectiveness of two mindfulness interventions for&#xD;
      stress, anxiety and burnout in mental health professionals. It is a 2-sequence, 2-period,&#xD;
      2-treatment crossover design with sequences AB and BA. Treatment A consists of a block of&#xD;
      five sessions of bodyfulness exercises, whereas experimental treatment B consists of a block&#xD;
      of five sessions of sitting mindfulness meditation exercises. In the sixth session, the&#xD;
      exercise blocks will be exchanged. Each group will be composed of half the sample, with a&#xD;
      initial sample of 130. The principal hypothesis is that both interventions will decrease&#xD;
      stress and anxiety levels and professional burnout, with body-centered exercises being at&#xD;
      least as effective as mindfulness sitting meditations. Secondarily, the personality type will&#xD;
      be analyzed as a moderating variable in those variables in which the interventions will be&#xD;
      effective. Third, a qualitative study will be conducted in order to analyze the perceptions&#xD;
      of change and experiences in Cuban mental health professionals who are beginner meditators.&#xD;
      This study will allow to understand the differential effectiveness of bodyfulness and&#xD;
      midfulness and what types of personality may benefit most from different types of meditation&#xD;
      interventions. Also, it will hell to get a deeper understanding of mindfulness practice in a&#xD;
      new cultural context (i.e., Cuba). A previous pilot study will be conduct to investigate the&#xD;
      acceptability and effectiveness of a culturally-adapted mindfulness-based intervention in&#xD;
      Cuba.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Actual">January 7, 2019</completion_date>
  <primary_completion_date type="Actual">May 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Stress at 5 weeks</measure>
    <time_frame>Baseline, Post- treatment 5 weeks from baseline</time_frame>
    <description>Stress measured using Seppo Aro Symptomatic Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Burnout at 5 weeks</measure>
    <time_frame>Baseline, Post- treatment 5 weeks from baseline</time_frame>
    <description>Burnout measured using Moreno Short Questionnaire of Burnout.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Stress at 10 weeks</measure>
    <time_frame>Baseline, Post- treatment 10 weeks</time_frame>
    <description>Stress measured using Seppo Aro Symptomatic Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Stress at three-months follow-up</measure>
    <time_frame>Baseline, Three-months follow-up</time_frame>
    <description>Stress measured using Seppo Aro Symptomatic Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Burnout at 10 weeks</measure>
    <time_frame>Baseline, Post- treatment 10 weeks</time_frame>
    <description>Burnout measured using Moreno Short Questionnaire of Burnout.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Burnout at at three-months follow-up</measure>
    <time_frame>Baseline, Three-months follow-up</time_frame>
    <description>Burnout measured using Moreno Short Questionnaire of Burnout.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline State Anxiety at 5 weeks</measure>
    <time_frame>Baseline, Post- treatment 5 weeks from baseline</time_frame>
    <description>State anxiety measured using State Anxiety Inventary IDARE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline State Anxiety at 10 weeks</measure>
    <time_frame>Baseline, Post- treatment 10 weeks</time_frame>
    <description>State anxiety measured using State Anxiety Inventary IDARE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline State Anxiety at three-months follow-up</measure>
    <time_frame>Baseline, Three-months follow-up</time_frame>
    <description>State anxiety measured using State Anxiety Inventary IDARE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic data</measure>
    <time_frame>Baseline</time_frame>
    <description>Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The sixteen personality factor questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>Course A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Course B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting Mindfulness Exercises.</intervention_name>
    <description>5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation</description>
    <arm_group_label>Course A</arm_group_label>
    <arm_group_label>Course B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Body Mindfulness Exercises</intervention_name>
    <description>5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements</description>
    <arm_group_label>Course A</arm_group_label>
    <arm_group_label>Course B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be a full time mental health professional&#xD;
&#xD;
          -  To be 18 years or older&#xD;
&#xD;
          -  To be able to attend weekly sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To suffer a pathology that discourages participation in the study.&#xD;
&#xD;
          -  Previous training in mindfulness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Angel Santed Germán, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Nacional a Distancia (España)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Justo R Fabelo Roche, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad de Ciencias Médicas de La Habana (Cuba)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Justo Reinalod Fabelo Roche</name>
      <address>
        <city>La Habana</city>
        <country>Cuba</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cuba</country>
  </location_countries>
  <link>
    <url>http://portal.uned.es/portal/page?_pageid=93,25453043&amp;_dad=portal&amp;_schema=PORTAL</url>
    <description>Investigations at the National Distance Education University</description>
  </link>
  <reference>
    <citation>de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Halland E, Bjorndal A. Does Personality Moderate the Effects of Mindfulness Training for Medical and Psychology Students? Mindfulness (N Y). 2015;6(2):281-289. doi: 10.1007/s12671-013-0258-y.</citation>
    <PMID>25798208</PMID>
  </reference>
  <reference>
    <citation>Goodman MJ, Schorling JB. A mindfulness course decreases burnout and improves well-being among healthcare providers. Int J Psychiatry Med. 2012;43(2):119-28. doi: 10.2190/PM.43.2.b.</citation>
    <PMID>22849035</PMID>
  </reference>
  <reference>
    <citation>Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.</citation>
    <PMID>24395196</PMID>
  </reference>
  <reference>
    <citation>Ireland MJ, Clough B, Gill K, Langan F, O'Connor A, Spencer L. A randomized controlled trial of mindfulness to reduce stress and burnout among intern medical practitioners. Med Teach. 2017 Apr;39(4):409-414. doi: 10.1080/0142159X.2017.1294749. Epub 2017 Feb 28.</citation>
    <PMID>28379084</PMID>
  </reference>
  <reference>
    <citation>Irving JA, Dobkin PL, Park J. Cultivating mindfulness in health care professionals: a review of empirical studies of mindfulness-based stress reduction (MBSR). Complement Ther Clin Pract. 2009 May;15(2):61-6. doi: 10.1016/j.ctcp.2009.01.002. Epub 2009 Feb 28.</citation>
    <PMID>19341981</PMID>
  </reference>
  <reference>
    <citation>Morse G, Salyers MP, Rollins AL, Monroe-DeVita M, Pfahler C. Burnout in mental health services: a review of the problem and its remediation. Adm Policy Ment Health. 2012 Sep;39(5):341-52. doi: 10.1007/s10488-011-0352-1.</citation>
    <PMID>21533847</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>meditation</keyword>
  <keyword>stress</keyword>
  <keyword>burn-out</keyword>
  <keyword>personality</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data that support the findings of this study are available from the corresponding author, [Miguel A. Santed], upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296254
org study id: 48817036RRI
nct id: NCT03296254
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from Baseline Stress at 5 weeks
time frame: Baseline, Post- treatment 5 weeks from baseline
description: Stress measured using Seppo Aro Symptomatic Stress Scale
measure: Change from Baseline Burnout at 5 weeks
time frame: Baseline, Post- treatment 5 weeks from baseline
description: Burnout measured using Moreno Short Questionnaire of Burnout.
measure: Change from Baseline Stress at 10 weeks
time frame: Baseline, Post- treatment 10 weeks
description: Stress measured using Seppo Aro Symptomatic Stress Scale
measure: Change from Baseline Stress at three-months follow-up
time frame: Baseline, Three-months follow-up
description: Stress measured using Seppo Aro Symptomatic Stress Scale
measure: Change from Baseline Burnout at 10 weeks
time frame: Baseline, Post- treatment 10 weeks
description: Burnout measured using Moreno Short Questionnaire of Burnout.
measure: Change from Baseline Burnout at at three-months follow-up
time frame: Baseline, Three-months follow-up
description: Burnout measured using Moreno Short Questionnaire of Burnout.
measure: Change from Baseline State Anxiety at 5 weeks
time frame: Baseline, Post- treatment 5 weeks from baseline
description: State anxiety measured using State Anxiety Inventary IDARE
measure: Change from Baseline State Anxiety at 10 weeks
time frame: Baseline, Post- treatment 10 weeks
description: State anxiety measured using State Anxiety Inventary IDARE
measure: Change from Baseline State Anxiety at three-months follow-up
time frame: Baseline, Three-months follow-up
description: State anxiety measured using State Anxiety Inventary IDARE
measure: Sociodemographic data
time frame: Baseline
description: Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.
measure: The sixteen personality factor questionnaire
time frame: Baseline
description: Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.
arm group label: Course A
arm group type: Experimental
description: Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
arm group label: Course B
arm group type: Experimental
description: Sitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
intervention type: Behavioral
intervention name: Sitting Mindfulness Exercises.
description: 5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
arm group label: Course A
arm group label: Course B
intervention type: Behavioral
intervention name: Body Mindfulness Exercises
description: 5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements
arm group label: Course A
arm group label: Course B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Miguel Angel Santed Germán, PhD
role: Study Director
affiliation: Universidad Nacional a Distancia (España)
last name: Justo R Fabelo Roche, PhD
role: Study Chair
affiliation: Universidad de Ciencias Médicas de La Habana (Cuba)
facility: 
country: Cuba
url: http://portal.uned.es/portal/page?_pageid=93,25453043&_dad=portal&_schema=PORTAL
description: Investigations at the National Distance Education University
citation: de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Halland E, Bjorndal A. Does Personality Moderate the Effects of Mindfulness Training for Medical and Psychology Students? Mindfulness (N Y). 2015;6(2):281-289. doi: 10.1007/s12671-013-0258-y.
PMID: 25798208
citation: Goodman MJ, Schorling JB. A mindfulness course decreases burnout and improves well-being among healthcare providers. Int J Psychiatry Med. 2012;43(2):119-28. doi: 10.2190/PM.43.2.b.
PMID: 22849035
citation: Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
PMID: 24395196
citation: Ireland MJ, Clough B, Gill K, Langan F, O'Connor A, Spencer L. A randomized controlled trial of mindfulness to reduce stress and burnout among intern medical practitioners. Med Teach. 2017 Apr;39(4):409-414. doi: 10.1080/0142159X.2017.1294749. Epub 2017 Feb 28.
PMID: 28379084
citation: Irving JA, Dobkin PL, Park J. Cultivating mindfulness in health care professionals: a review of empirical studies of mindfulness-based stress reduction (MBSR). Complement Ther Clin Pract. 2009 May;15(2):61-6. doi: 10.1016/j.ctcp.2009.01.002. Epub 2009 Feb 28.
PMID: 19341981
citation: Morse G, Salyers MP, Rollins AL, Monroe-DeVita M, Pfahler C. Burnout in mental health services: a review of the problem and its remediation. Adm Policy Ment Health. 2012 Sep;39(5):341-52. doi: 10.1007/s10488-011-0352-1.
PMID: 21533847
responsible party type: Sponsor
mesh term: Burnout, Psychological
sharing ipd: Yes
ipd description: The data that support the findings of this study are available from the corresponding author, [Miguel A. Santed], upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)