<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/NCT04462484</url>
  </required_header>
  <id_info>
    <org_study_id>13-12/2020</org_study_id>
    <nct_id>NCT04462484</nct_id>
  </id_info>
  <brief_title>Online Self-care Training Program (MAGO Study)</brief_title>
  <acronym>MAGO</acronym>
  <official_title>Study Protocol of a Randomized Controlled Trial of an Online Self-Care Training Programme to Reduce Burnout and Promote Work Engagement in Clinical Psychologists: MAGO Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Padova</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>
      This study aims to determine the efficacy of MAGO (Online Self-care Training Program for&#xD;
      Psychologists), a person-directed, individual, occupational intervention via videoconference&#xD;
      in six sessions on a weekly basis. By promoting self-care behaviors, it is expected to reduce&#xD;
      burnout levels and to increase work engagement in clinical psychologists working in Chile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical psychologists are susceptible to develop burnout as a result of facing consistently&#xD;
      emotionally taxing job demands and a high requirement for empathy. Implementing self-care&#xD;
      behaviors can help to prevent negative consequences of work stress and the promotion of&#xD;
      positive outcomes such as optimal professional functioning and enhanced well-being in&#xD;
      psychologists.&#xD;
&#xD;
      The intervention is a person-directed, individual, primary occupational intervention. It will&#xD;
      be carried out via videoconference in six weekly sessions of 45 minutes. MAGO is a program&#xD;
      derived from Self-care Assessment for Psychology (SCAP). From a preventive perspective on&#xD;
      self-care, items represent strategies or behaviors that may be integrated into one's&#xD;
      professional and personal life on a more ongoing and proactive basis to promote&#xD;
      well-functioning.&#xD;
&#xD;
      Chile has presented a slow but progressive development of e-mental health research, and&#xD;
      Internet-based interventions are at an early stage of development in this country. Using&#xD;
      videoconference and web-delivered questionnaires are crucial in reaching psychologists&#xD;
      considering problems such as long distances of transportation and a tiny budget for mental&#xD;
      health. Nevertheless, Chile scores 52 in the Global Connectivity Index, while digital&#xD;
      technologies are highly utilized across all social strata.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">February 13, 2022</completion_date>
  <primary_completion_date type="Actual">February 13, 2022</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>Parallel Assignment</intervention_model>
    <intervention_model_description>MAGO is a parallel, two-armed randomized controlled trial with three assessment points (baseline, post-intervention, and six-month follow-up). Participants will be randomized for the program or a no-treatment group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline occupational burnout</measure>
    <time_frame>8 weeks and 6 months.</time_frame>
    <description>Maslach Burnout Inventory for human services (MBI-HSS) is comprised of 22 items to evaluate emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF). Total score ranges from 0 to 132, with higher scores indicating more occupational burnout.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline work engagement</measure>
    <time_frame>8 weeks and 6 months.</time_frame>
    <description>Utrecht Work Engagement (UWES-17) is comprised of 17 items. Total score ranges from 0 to 102, with higher scores indicating more work engagement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline self-care behaviors</measure>
    <time_frame>8 weeks and 6 months.</time_frame>
    <description>Self-Care Assessment for Psychologists (SCAP) is comprised of 21 items. Total score ranges from 21 to 147, with higher scores indicating higher frequency of self-care behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline general health</measure>
    <time_frame>8 weeks and 6 months.</time_frame>
    <description>General Health Questionnaire (GHQ-12) is comprised of 12 items. Total score ranges from 0 to 12, with higher scores indicating lower levels general health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline perceived social support</measure>
    <time_frame>Baseline, 8 weeks, 6 months.</time_frame>
    <description>Multidimensional Scale of Perceived Social Support (MSPSS) is comprised of 12 items. Total score ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline depression symptoms</measure>
    <time_frame>8 weeks and 6 months.</time_frame>
    <description>Beck Depression Inventory (BDI-II) is comprised of 21 items. Total score ranges from 0 to 63, with higher scores indicating higher levels of depressive symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline anxiety symptoms</measure>
    <time_frame>8 weeks and 6 months.</time_frame>
    <description>Beck Anxiety Inventory (BAI) is comprised of 21 items. Total score ranges from 0 to 63 with higher scores indicating higher levels of anxiety symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Occupational Burnout</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Videoconference</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>videoconference</intervention_name>
    <description>The intervention is a person-directed, individual, primary occupational intervention. It will be carried out via videoconference in six sessions of 45 minutes (on a weekly basis). Through guided dialogue, individual difficulties and opportunities of each subject will be examined in order to gain self-awareness of personal characteristics (strengths, limitations, maximum workload capacity) in their particular set of job demands and resources. Participants are encouraged to adopt the set of self-care strategies in each dimension, adapting them to their specific context. Activities will be carried out in Spanish by the researcher.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chilean psychologists&#xD;
&#xD;
          -  Currently working in the public sector in Chile&#xD;
&#xD;
          -  Available to attend to six online sessions&#xD;
&#xD;
          -  Willing to voluntarily participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects participating in psychotherapy as clients&#xD;
&#xD;
          -  High scores for depression or anxiety&#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>Sabrina Cipolletta, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Caterina Novara, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Chile</name>
      <address>
        <city>Santiago de Chile</city>
        <state>RM</state>
        <zip>7800284</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <link>
    <url>https://www.huawei.com/minisite/gci/assets/files/gci_2019_whitepaper_en.pdf?v=20191217v2</url>
    <description>Huawei Global Connectivity Index. (2019)</description>
  </link>
  <reference>
    <citation>Dorociak KE, Rupert PA, Bryant FB, Zahniser E. Development of the Professional Self-Care Scale. J Couns Psychol. 2017 Apr;64(3):325-334. doi: 10.1037/cou0000206. Epub 2017 Mar 9.</citation>
    <PMID>28277686</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Sabrina Cipolletta</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>burnout</keyword>
  <keyword>self-care</keyword>
  <keyword>online program</keyword>
  <keyword>telepsychology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04462484/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04462484
org study id: 13-12/2020
nct id: NCT04462484
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the efficacy of MAGO (Online Self-care Training Program for
      Psychologists), a person-directed, individual, occupational intervention via videoconference
      in six sessions on a weekly basis. By promoting self-care behaviors, it is expected to reduce
      burnout levels and to increase work engagement in clinical psychologists working in Chile.
Clinical psychologists are susceptible to develop burnout as a result of facing consistently
      emotionally taxing job demands and a high requirement for empathy. Implementing self-care
      behaviors can help to prevent negative consequences of work stress and the promotion of
      positive outcomes such as optimal professional functioning and enhanced well-being in
      psychologists.

      The intervention is a person-directed, individual, primary occupational intervention. It will
      be carried out via videoconference in six weekly sessions of 45 minutes. MAGO is a program
      derived from Self-care Assessment for Psychology (SCAP). From a preventive perspective on
      self-care, items represent strategies or behaviors that may be integrated into one's
      professional and personal life on a more ongoing and proactive basis to promote
      well-functioning.

      Chile has presented a slow but progressive development of e-mental health research, and
      Internet-based interventions are at an early stage of development in this country. Using
      videoconference and web-delivered questionnaires are crucial in reaching psychologists
      considering problems such as long distances of transportation and a tiny budget for mental
      health. Nevertheless, Chile scores 52 in the Global Connectivity Index, while digital
      technologies are highly utilized across all social strata.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: MAGO is a parallel, two-armed randomized controlled trial with three assessment points (baseline, post-intervention, and six-month follow-up). Participants will be randomized for the program or a no-treatment group.
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline occupational burnout
time frame: 8 weeks and 6 months.
description: Maslach Burnout Inventory for human services (MBI-HSS) is comprised of 22 items to evaluate emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF). Total score ranges from 0 to 132, with higher scores indicating more occupational burnout.
measure: Change from baseline work engagement
time frame: 8 weeks and 6 months.
description: Utrecht Work Engagement (UWES-17) is comprised of 17 items. Total score ranges from 0 to 102, with higher scores indicating more work engagement.
measure: Change from baseline self-care behaviors
time frame: 8 weeks and 6 months.
description: Self-Care Assessment for Psychologists (SCAP) is comprised of 21 items. Total score ranges from 21 to 147, with higher scores indicating higher frequency of self-care behaviors.
measure: Change from baseline general health
time frame: 8 weeks and 6 months.
description: General Health Questionnaire (GHQ-12) is comprised of 12 items. Total score ranges from 0 to 12, with higher scores indicating lower levels general health.
measure: Change from baseline perceived social support
time frame: Baseline, 8 weeks, 6 months.
description: Multidimensional Scale of Perceived Social Support (MSPSS) is comprised of 12 items. Total score ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.
measure: Change from baseline depression symptoms
time frame: 8 weeks and 6 months.
description: Beck Depression Inventory (BDI-II) is comprised of 21 items. Total score ranges from 0 to 63, with higher scores indicating higher levels of depressive symptomatology.
measure: Change from baseline anxiety symptoms
time frame: 8 weeks and 6 months.
description: Beck Anxiety Inventory (BAI) is comprised of 21 items. Total score ranges from 0 to 63 with higher scores indicating higher levels of anxiety symptoms.
arm group label: Control group
arm group type: No Intervention
description: No intervention
arm group label: Intervention group
arm group type: Experimental
description: Videoconference
intervention type: Behavioral
intervention name: videoconference
description: The intervention is a person-directed, individual, primary occupational intervention. It will be carried out via videoconference in six sessions of 45 minutes (on a weekly basis). Through guided dialogue, individual difficulties and opportunities of each subject will be examined in order to gain self-awareness of personal characteristics (strengths, limitations, maximum workload capacity) in their particular set of job demands and resources. Participants are encouraged to adopt the set of self-care strategies in each dimension, adapting them to their specific context. Activities will be carried out in Spanish by the researcher.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sabrina Cipolletta, PhD
role: Study Director
affiliation: University of Padova
last name: Caterina Novara, PhD
role: Study Director
affiliation: University of Padova
facility: 
country: Chile
url: https://www.huawei.com/minisite/gci/assets/files/gci_2019_whitepaper_en.pdf?v=20191217v2
description: Huawei Global Connectivity Index. (2019)
citation: Dorociak KE, Rupert PA, Bryant FB, Zahniser E. Development of the Professional Self-Care Scale. J Couns Psychol. 2017 Apr;64(3):325-334. doi: 10.1037/cou0000206. Epub 2017 Mar 9.
PMID: 28277686
responsible party type: Principal Investigator
investigator affiliation: University of Padova
investigator full name: Sabrina Cipolletta
investigator title: Associate Professor
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
sharing ipd: Undecided
provided document: 