<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/NCT03759795</url>
  </required_header>
  <id_info>
    <org_study_id>1819/IRASSR/1</org_study_id>
    <nct_id>NCT03759795</nct_id>
  </id_info>
  <brief_title>Bournemouth University Resilience Training for Surgeons</brief_title>
  <acronym>BURTS</acronym>
  <official_title>Ameliorating the Impact of Complications and Errors on Surgeons: Resilience Training for Surgeons.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bournemouth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bournemouth University</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 challenges that characterise surgical practice may result in a myriad of stressors that&#xD;
      impact upon the personal and professional lives of surgeons. This includes a high likelihood&#xD;
      that surgeons will have to deal with adverse patient outcomes due to surgical complications&#xD;
      and errors, sometime during their careers. Such stressors can have undesirable effects on the&#xD;
      surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of&#xD;
      regret), as well as lowered professional confidence and impaired perceptions of professional&#xD;
      competence. Furthermore, there is evidence that these kinds of negative impacts can also lead&#xD;
      to burnout and depression. As well as the detrimental effects on surgeons and those around&#xD;
      them, this in turn may lead to more errors and poorer outcomes for patients. This study will&#xD;
      examine the efficacy of an ACT based training intervention to enhance resilience and&#xD;
      psychological flexibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research in a range of occupational settings has indicated that resilience plays an important&#xD;
      role in ameliorating the impact of adverse events in high pressure environments. This project&#xD;
      will use a randomised controlled trial research design to assess the efficacy of brief&#xD;
      one-to-one Acceptance and Commitment Training (ACTr), designed to enhance surgeons'&#xD;
      psychological resilience. According to the model ACTr is based on, psychopathology is&#xD;
      primarily the consequence of psychological inflexibility i.e. inability to persist or change&#xD;
      behaviour according to long-term values due to language and cognition skills, which has&#xD;
      particular significance when an individual is confronted with stress or adversity.&#xD;
&#xD;
      The main aim of this research is to assess the efficacy of a brief one-to-one Acceptance and&#xD;
      Commitment Training course. Researchers wish to ascertain whether such a course can increase&#xD;
      surgeons' resilience by increasing psychological flexibility, valuing and self-compassion&#xD;
      (all of which are expected to be positively impacted by this training). This research will&#xD;
      fill a gap in the relevant research literature; namely that no research project as far as we&#xD;
      are aware has evaluated ACTr as a means to enhance resilience in surgeons. In fact any&#xD;
      research conducted on resilience training with a surgical population is rare.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2018</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Randomised Controlled Trial. Wait-list control for half participants. Other half receive ACTr (acceptance and commitment training) intention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Resilience - Brief Resilience Scale (BRS)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of psychological resilience. Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Health - General Health Questionnaire (GHQ-12).</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self reported measure of minor psychological symptomology in a non-clinical population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CBI (Copenhagen Burnout Inventory)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of vulnerability to burnout. Lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASS21 (Depression Anxiety and Stress Scale)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of depression, stress and anxiety. Lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VLQ (Value Living Questionnaire)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of valuing. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WAAQ (Work related Acceptance and Action Questionnaire)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of work related psychological flexibility. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AAQII (Acceptance and Action Questionnaire)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of general psychological inflexibility. Lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCS (Self Compassion Scale)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of self compassion. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPS (Sense of Preparedness Scale)</measure>
    <time_frame>20 weeks</time_frame>
    <description>A self-report measure of preparedness for potential future events. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Effect of Training</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acceptance and Commitment Training (ACTr)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention during trial. Participants in this group will be offered the training once the study is complete.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACTr (Acceptance and Commitment Training)</intervention_name>
    <description>The programme is based on Acceptance and Commitment Training (ACT), a contemporary, empirically supported approach to psychological well-being.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Trainee surgeons and consultant surgeons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen Bolderston</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bournemouth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poole Hopsital</name>
      <address>
        <city>Poole</city>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Finnes A, Ghaderi A, Dahl J, Nager A, Enebrink P. Randomized controlled trial of acceptance and commitment therapy and a workplace intervention for sickness absence due to mental disorders. J Occup Health Psychol. 2019 Feb;24(1):198-212. doi: 10.1037/ocp0000097. Epub 2017 Sep 28.</citation>
    <PMID>28956942</PMID>
  </reference>
  <reference>
    <citation>Flaxman PE, Bond FW. A randomised worksite comparison of acceptance and commitment therapy and stress inoculation training. Behav Res Ther. 2010 Aug;48(8):816-20. doi: 10.1016/j.brat.2010.05.004. Epub 2010 May 8.</citation>
    <PMID>20627269</PMID>
  </reference>
  <reference>
    <citation>Pinto A, Faiz O, Davis R, Almoudaris A, Vincent C. Surgical complications and their impact on patients' psychosocial well-being: a systematic review and meta-analysis. BMJ Open. 2016 Feb 16;6(2):e007224. doi: 10.1136/bmjopen-2014-007224.</citation>
    <PMID>26883234</PMID>
  </reference>
  <reference>
    <citation>Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.</citation>
    <PMID>19934755</PMID>
  </reference>
  <reference>
    <citation>Balch CM, Shanafelt TD, Dyrbye L, Sloan JA, Russell TR, Bechamps GJ, Freischlag JA. Surgeon distress as calibrated by hours worked and nights on call. J Am Coll Surg. 2010 Nov;211(5):609-19. doi: 10.1016/j.jamcollsurg.2010.06.393. Epub 2010 Sep 20.</citation>
    <PMID>20851643</PMID>
  </reference>
  <reference>
    <citation>Flaxman P. , Bond, F., Livheim, F. (2013): The Mindful and Effective Employee: An Acceptance and Commitment Therapy Training Manual for Improving Well-Being and Performance. New Harbinger Publications; 2013</citation>
  </reference>
  <reference>
    <citation>Turner, K., Johnson, C., Thomas, K., Bolderston, H., &amp; McDougall, S. (2016). The impact of complications and errors on surgeons. The Bulletin Of The Royal College Of Surgeons Of England, 98(9), 404-407. doi: 10.1308/rcsbull.2016.404</citation>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Resilience</keyword>
  <keyword>Psychological flexibility</keyword>
  <keyword>Acceptance and Commitment Training</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03759795/Prot_001.pdf</document_url>
    </provided_document>
    <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>January 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03759795/ICF_000.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/NCT03759795
org study id: 1819/IRASSR/1
nct id: NCT03759795
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The challenges that characterise surgical practice may result in a myriad of stressors that
      impact upon the personal and professional lives of surgeons. This includes a high likelihood
      that surgeons will have to deal with adverse patient outcomes due to surgical complications
      and errors, sometime during their careers. Such stressors can have undesirable effects on the
      surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of
      regret), as well as lowered professional confidence and impaired perceptions of professional
      competence. Furthermore, there is evidence that these kinds of negative impacts can also lead
      to burnout and depression. As well as the detrimental effects on surgeons and those around
      them, this in turn may lead to more errors and poorer outcomes for patients. This study will
      examine the efficacy of an ACT based training intervention to enhance resilience and
      psychological flexibility.
Research in a range of occupational settings has indicated that resilience plays an important
      role in ameliorating the impact of adverse events in high pressure environments. This project
      will use a randomised controlled trial research design to assess the efficacy of brief
      one-to-one Acceptance and Commitment Training (ACTr), designed to enhance surgeons'
      psychological resilience. According to the model ACTr is based on, psychopathology is
      primarily the consequence of psychological inflexibility i.e. inability to persist or change
      behaviour according to long-term values due to language and cognition skills, which has
      particular significance when an individual is confronted with stress or adversity.

      The main aim of this research is to assess the efficacy of a brief one-to-one Acceptance and
      Commitment Training course. Researchers wish to ascertain whether such a course can increase
      surgeons' resilience by increasing psychological flexibility, valuing and self-compassion
      (all of which are expected to be positively impacted by this training). This research will
      fill a gap in the relevant research literature; namely that no research project as far as we
      are aware has evaluated ACTr as a means to enhance resilience in surgeons. In fact any
      research conducted on resilience training with a surgical population is rare.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Randomised Controlled Trial. Wait-list control for half participants. Other half receive ACTr (acceptance and commitment training) intention.
measure: Resilience - Brief Resilience Scale (BRS)
time frame: 20 weeks
description: A self-report measure of psychological resilience. Higher values represent a better outcome.
measure: General Health - General Health Questionnaire (GHQ-12).
time frame: 20 weeks
description: A self reported measure of minor psychological symptomology in a non-clinical population.
measure: CBI (Copenhagen Burnout Inventory)
time frame: 20 weeks
description: A self-report measure of vulnerability to burnout. Lower values represent a better outcome.
measure: DASS21 (Depression Anxiety and Stress Scale)
time frame: 20 weeks
description: A self-report measure of depression, stress and anxiety. Lower values represent a better outcome.
measure: VLQ (Value Living Questionnaire)
time frame: 20 weeks
description: A self-report measure of valuing. Higher values represent a better outcome.
measure: WAAQ (Work related Acceptance and Action Questionnaire)
time frame: 20 weeks
description: A self-report measure of work related psychological flexibility. Higher values represent a better outcome.
measure: AAQII (Acceptance and Action Questionnaire)
time frame: 20 weeks
description: A self-report measure of general psychological inflexibility. Lower values represent a better outcome.
measure: SCS (Self Compassion Scale)
time frame: 20 weeks
description: A self-report measure of self compassion. Higher values represent a better outcome.
measure: SPS (Sense of Preparedness Scale)
time frame: 20 weeks
description: A self-report measure of preparedness for potential future events. Higher values represent a better outcome.
arm group label: Intervention Group
arm group type: Experimental
description: Acceptance and Commitment Training (ACTr)
arm group label: Wait-list control
arm group type: No Intervention
description: No intervention during trial. Participants in this group will be offered the training once the study is complete.
intervention type: Behavioral
intervention name: ACTr (Acceptance and Commitment Training)
description: The programme is based on Acceptance and Commitment Training (ACT), a contemporary, empirically supported approach to psychological well-being.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helen Bolderston
role: Principal Investigator
affiliation: Bournemouth University
facility: 
facility: 
country: United Kingdom
citation: Finnes A, Ghaderi A, Dahl J, Nager A, Enebrink P. Randomized controlled trial of acceptance and commitment therapy and a workplace intervention for sickness absence due to mental disorders. J Occup Health Psychol. 2019 Feb;24(1):198-212. doi: 10.1037/ocp0000097. Epub 2017 Sep 28.
PMID: 28956942
citation: Flaxman PE, Bond FW. A randomised worksite comparison of acceptance and commitment therapy and stress inoculation training. Behav Res Ther. 2010 Aug;48(8):816-20. doi: 10.1016/j.brat.2010.05.004. Epub 2010 May 8.
PMID: 20627269
citation: Pinto A, Faiz O, Davis R, Almoudaris A, Vincent C. Surgical complications and their impact on patients' psychosocial well-being: a systematic review and meta-analysis. BMJ Open. 2016 Feb 16;6(2):e007224. doi: 10.1136/bmjopen-2014-007224.
PMID: 26883234
citation: Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.
PMID: 19934755
citation: Balch CM, Shanafelt TD, Dyrbye L, Sloan JA, Russell TR, Bechamps GJ, Freischlag JA. Surgeon distress as calibrated by hours worked and nights on call. J Am Coll Surg. 2010 Nov;211(5):609-19. doi: 10.1016/j.jamcollsurg.2010.06.393. Epub 2010 Sep 20.
PMID: 20851643
citation: Flaxman P. , Bond, F., Livheim, F. (2013): The Mindful and Effective Employee: An Acceptance and Commitment Therapy Training Manual for Improving Well-Being and Performance. New Harbinger Publications; 2013
citation: Turner, K., Johnson, C., Thomas, K., Bolderston, H., & McDougall, S. (2016). The impact of complications and errors on surgeons. The Bulletin Of The Royal College Of Surgeons Of England, 98(9), 404-407. doi: 10.1308/rcsbull.2016.404
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
provided document: 