<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/NCT04457804</url>
  </required_header>
  <id_info>
    <org_study_id>01</org_study_id>
    <nct_id>NCT04457804</nct_id>
  </id_info>
  <brief_title>A Brief Virtual ACT Workshop for Emotional Eating</brief_title>
  <official_title>A Brief Virtual ACT Workshop for Emotional Eating</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill 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>
      Emotional eating is a behaviour that has been linked to weight concerns, mental health&#xD;
      concerns, and disordered eating. Effective interventions have been developed to treat&#xD;
      emotional eating, however these exist solely in the context of promoting weight loss.&#xD;
      Emotional eating is not exclusive to those who struggle with weight and thus interventions&#xD;
      are needed that target those who engage in emotional eating regardless of their weight&#xD;
      status. The present study aims to do so through the implementation of a brief online&#xD;
      Acceptance and Commitment Therapy (ACT) workshop for emotional eaters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emotional eating is defined as increased food consumption in response to negative emotions,&#xD;
      and has been linked to weight concerns, mental health concerns, and disordered eating&#xD;
      behaviours. Effective interventions have been developed that address emotional eating, namely&#xD;
      to improve weight loss. Such interventions are based in Acceptance and Commitment Therapy&#xD;
      (ACT), which encourages tolerance of internal cues, such as emotions, and external cues, such&#xD;
      as food.&#xD;
&#xD;
      Previous studies have found that brief ACT interventions are effective for the reduction of&#xD;
      emotional eating. Our laboratory has recently developed and pilot-tested a one-day ACT&#xD;
      workshop intervention for emotional eating, which was found to be effective for reducing&#xD;
      emotional eating and deemed feasible and acceptable by participants.&#xD;
&#xD;
      The present study was developed with the aim to adapt the above mentioned workshop&#xD;
      intervention to an online format in the context of the COVID-19 crisis. The study aims to&#xD;
      test the efficacy, feasibility and acceptability of a brief, online version of the above&#xD;
      mentioned one-day ACT workshop for emotional eating. The workshops will be delivered through&#xD;
      the Zoom online platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants will be assigned to the same intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional Eating - Post-Intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Eating - 2 weeks post-intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Eating - 3 months Post-Intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distress Tolerance - Post-Intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Tolerance - 2-weeks Post-Intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Tolerance - 3-months Post-Intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Craving Acceptance and Action - Post-intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Craving Acceptance and Action - 2-weeks Post-intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Craving Acceptance and Action - 3-months Post-intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Eating - Post-Intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 (&quot;never&quot; / &quot;rarely&quot;) to 4 (&quot;usually&quot;/ &quot;always&quot;), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Eating - 2-weeks Post-Intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 (&quot;never&quot; / &quot;rarely&quot;) to 4 (&quot;usually&quot;/ &quot;always&quot;), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Eating - 3-months Post-Intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 (&quot;never&quot; / &quot;rarely&quot;) to 4 (&quot;usually&quot;/ &quot;always&quot;), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACT Values Application - Post-intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACT Values Application - 2-weeks Post-intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACT Values Application - 3-months Post-intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Eating Frequency - Post-intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Eating Frequency - 2-weeks Post-intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Eating Frequency - 3-months Post-intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to Stop Emotional Eating - Post-intervention</measure>
    <time_frame>Assessed at post-intervention (1 week following the first session)</time_frame>
    <description>As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to Stop Emotional Eating - 2-weeks Post-intervention</measure>
    <time_frame>Assessed 2-weeks following the second (last) session</time_frame>
    <description>As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to Stop Emotional Eating - 3-months Post-intervention</measure>
    <time_frame>Assessed 3-months following the second (last) session</time_frame>
    <description>As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility Data: Recruitment Rates</measure>
    <time_frame>Assessed during the recruitment period (i.e. over a period of 2 months)</time_frame>
    <description>Overall number of participants who expressed interest in the workshop over the recruitment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility Data: Workshop Attendance Rates</measure>
    <time_frame>Assessed during the treatment period: from baseline to post-treatment (i.e. over the course of 1 week).</time_frame>
    <description>Number of participants who received the intervention (i.e. who attended both workshop sessions) out of the number of participants who signed up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility Data: Dropout Rates</measure>
    <time_frame>Assessed from baseline to the 3-month follow-up assessment.</time_frame>
    <description>Number of participants who have dropped out or withdrawn from the study at any time point from baseline assessment to last follow-up assessment. Number of dropouts and withdrawals will be kept track of at each study time-point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility Data: Loss-to-Follow-Up Rates</measure>
    <time_frame>Assessed at the 2-week follow-up time point and the 3-month follow-up time point.</time_frame>
    <description>Number of participants (out of those who have attended the workshop) who have not completed the follow-up questionnaire(s). The number of participants with missing follow-up data will be kept track of at all follow-up time points (post-treatment, 2-week follow-up, and 3-month follow-up).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Emotional Eating</condition>
  <condition>Eating Behavior</condition>
  <arm_group>
    <arm_group_label>Online ACT workshop for Emotional Eating</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be assigned to 2, 1.5 hour interventions using Acceptance and Commitment Therapy (ACT) techniques to help reduce emotional eating.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual ACT Workshop for Emotional Eating</intervention_name>
    <description>This is a brief online intervention using Acceptance and Commitment Therapy (ACT) technique to target and reduce emotional eating. The intervention will be modeled after Frayn and Knäuper's 1-day ACT workshop for emotional eating intervention, which was derived from Forman and colleagues' &quot;Mind Your Health Program&quot;. During the workshop, the following topics will be discussed, based on the three processes of ACT: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness/awareness.</description>
    <arm_group_label>Online ACT workshop for Emotional Eating</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identifying as emotional-eater&#xD;
&#xD;
          -  Being over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - N/A&#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>Bärbel Knauper, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McGill University</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3A1G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13. Erratum In: Obesity (Silver Spring). 2014 Mar;22(3):971.</citation>
    <PMID>23666772</PMID>
  </reference>
  <reference>
    <citation>Geliebter A, Aversa A. Emotional eating in overweight, normal weight, and underweight individuals. Eat Behav. 2003 Jan;3(4):341-7. doi: 10.1016/s1471-0153(02)00100-9.</citation>
    <PMID>15000995</PMID>
  </reference>
  <reference>
    <citation>Hou L, Li F, Wang Y, Ou Z, Xu D, Tan W, Dai M. Association between dietary patterns and coronary heart disease: a meta-analysis of prospective cohort studies. Int J Clin Exp Med. 2015 Jan 15;8(1):781-90. eCollection 2015.</citation>
    <PMID>25785058</PMID>
  </reference>
  <reference>
    <citation>Konttinen H, Mannisto S, Sarlio-Lahteenkorva S, Silventoinen K, Haukkala A. Emotional eating, depressive symptoms and self-reported food consumption. A population-based study. Appetite. 2010 Jun;54(3):473-9. doi: 10.1016/j.appet.2010.01.014. Epub 2010 Feb 4.</citation>
    <PMID>20138944</PMID>
  </reference>
  <reference>
    <citation>Lillis J, Niemeier HM, Thomas JG, Unick J, Ross KM, Leahey TM, Kendra KE, Dorfman L, Wing RR. A randomized trial of an acceptance-based behavioral intervention for weight loss in people with high internal disinhibition. Obesity (Silver Spring). 2016 Dec;24(12):2509-2514. doi: 10.1002/oby.21680. Epub 2016 Nov 2.</citation>
    <PMID>27804255</PMID>
  </reference>
  <reference>
    <citation>Oliver G, Wardle J, Gibson EL. Stress and food choice: a laboratory study. Psychosom Med. 2000 Nov-Dec;62(6):853-65. doi: 10.1097/00006842-200011000-00016.</citation>
    <PMID>11139006</PMID>
  </reference>
  <reference>
    <citation>Frayn M, Khanyari S, Knauper B. A 1-day acceptance and commitment therapy workshop leads to reductions in emotional eating in adults. Eat Weight Disord. 2020 Oct;25(5):1399-1411. doi: 10.1007/s40519-019-00778-6. Epub 2019 Sep 20.</citation>
    <PMID>31541426</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Barbel Knauper</investigator_full_name>
    <investigator_title>James McGill Professor</investigator_title>
  </responsible_party>
  <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, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04457804/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04457804/SAP_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/NCT04457804
org study id: 01
nct id: NCT04457804
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emotional eating is a behaviour that has been linked to weight concerns, mental health
      concerns, and disordered eating. Effective interventions have been developed to treat
      emotional eating, however these exist solely in the context of promoting weight loss.
      Emotional eating is not exclusive to those who struggle with weight and thus interventions
      are needed that target those who engage in emotional eating regardless of their weight
      status. The present study aims to do so through the implementation of a brief online
      Acceptance and Commitment Therapy (ACT) workshop for emotional eaters.
Emotional eating is defined as increased food consumption in response to negative emotions,
      and has been linked to weight concerns, mental health concerns, and disordered eating
      behaviours. Effective interventions have been developed that address emotional eating, namely
      to improve weight loss. Such interventions are based in Acceptance and Commitment Therapy
      (ACT), which encourages tolerance of internal cues, such as emotions, and external cues, such
      as food.

      Previous studies have found that brief ACT interventions are effective for the reduction of
      emotional eating. Our laboratory has recently developed and pilot-tested a one-day ACT
      workshop intervention for emotional eating, which was found to be effective for reducing
      emotional eating and deemed feasible and acceptable by participants.

      The present study was developed with the aim to adapt the above mentioned workshop
      intervention to an online format in the context of the COVID-19 crisis. The study aims to
      test the efficacy, feasibility and acceptability of a brief, online version of the above
      mentioned one-day ACT workshop for emotional eating. The workshops will be delivered through
      the Zoom online platform.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will be assigned to the same intervention.
primary purpose: Treatment
masking: None (Open Label)
measure: Emotional Eating - Post-Intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.
measure: Emotional Eating - 2 weeks post-intervention
time frame: Assessed 2-weeks following the second (last) session
description: Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.
measure: Emotional Eating - 3 months Post-Intervention
time frame: Assessed 3-months following the second (last) session
description: Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.
measure: Distress Tolerance - Post-Intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.
measure: Distress Tolerance - 2-weeks Post-Intervention
time frame: Assessed 2-weeks following the second (last) session
description: Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.
measure: Distress Tolerance - 3-months Post-Intervention
time frame: Assessed 3-months following the second (last) session
description: Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.
measure: Food Craving Acceptance and Action - Post-intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.
measure: Food Craving Acceptance and Action - 2-weeks Post-intervention
time frame: Assessed 2-weeks following the second (last) session
description: Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.
measure: Food Craving Acceptance and Action - 3-months Post-intervention
time frame: Assessed 3-months following the second (last) session
description: Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.
measure: Mindful Eating - Post-Intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 ("never" / "rarely") to 4 ("usually"/ "always"), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales.
measure: Mindful Eating - 2-weeks Post-Intervention
time frame: Assessed 2-weeks following the second (last) session
description: Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 ("never" / "rarely") to 4 ("usually"/ "always"), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales.
measure: Mindful Eating - 3-months Post-Intervention
time frame: Assessed 3-months following the second (last) session
description: Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 ("never" / "rarely") to 4 ("usually"/ "always"), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales.
measure: ACT Values Application - Post-intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.
measure: ACT Values Application - 2-weeks Post-intervention
time frame: Assessed 2-weeks following the second (last) session
description: Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.
measure: ACT Values Application - 3-months Post-intervention
time frame: Assessed 3-months following the second (last) session
description: Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.
measure: Emotional Eating Frequency - Post-intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.
measure: Emotional Eating Frequency - 2-weeks Post-intervention
time frame: Assessed 2-weeks following the second (last) session
description: As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.
measure: Emotional Eating Frequency - 3-months Post-intervention
time frame: Assessed 3-months following the second (last) session
description: As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.
measure: Ability to Stop Emotional Eating - Post-intervention
time frame: Assessed at post-intervention (1 week following the first session)
description: As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).
measure: Ability to Stop Emotional Eating - 2-weeks Post-intervention
time frame: Assessed 2-weeks following the second (last) session
description: As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).
measure: Ability to Stop Emotional Eating - 3-months Post-intervention
time frame: Assessed 3-months following the second (last) session
description: As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).
measure: Feasibility Data: Recruitment Rates
time frame: Assessed during the recruitment period (i.e. over a period of 2 months)
description: Overall number of participants who expressed interest in the workshop over the recruitment period.
measure: Feasibility Data: Workshop Attendance Rates
time frame: Assessed during the treatment period: from baseline to post-treatment (i.e. over the course of 1 week).
description: Number of participants who received the intervention (i.e. who attended both workshop sessions) out of the number of participants who signed up.
measure: Feasibility Data: Dropout Rates
time frame: Assessed from baseline to the 3-month follow-up assessment.
description: Number of participants who have dropped out or withdrawn from the study at any time point from baseline assessment to last follow-up assessment. Number of dropouts and withdrawals will be kept track of at each study time-point.
measure: Feasibility Data: Loss-to-Follow-Up Rates
time frame: Assessed at the 2-week follow-up time point and the 3-month follow-up time point.
description: Number of participants (out of those who have attended the workshop) who have not completed the follow-up questionnaire(s). The number of participants with missing follow-up data will be kept track of at all follow-up time points (post-treatment, 2-week follow-up, and 3-month follow-up).
arm group label: Online ACT workshop for Emotional Eating
arm group type: Experimental
description: All participants will be assigned to 2, 1.5 hour interventions using Acceptance and Commitment Therapy (ACT) techniques to help reduce emotional eating.
intervention type: Behavioral
intervention name: Virtual ACT Workshop for Emotional Eating
description: This is a brief online intervention using Acceptance and Commitment Therapy (ACT) technique to target and reduce emotional eating. The intervention will be modeled after Frayn and Knäuper's 1-day ACT workshop for emotional eating intervention, which was derived from Forman and colleagues' "Mind Your Health Program". During the workshop, the following topics will be discussed, based on the three processes of ACT: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness/awareness.
arm group label: Online ACT workshop for Emotional Eating
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bärbel Knauper, PhD
role: Principal Investigator
affiliation: McGill University
facility: 
country: Canada
citation: Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13. Erratum In: Obesity (Silver Spring). 2014 Mar;22(3):971.
PMID: 23666772
citation: Geliebter A, Aversa A. Emotional eating in overweight, normal weight, and underweight individuals. Eat Behav. 2003 Jan;3(4):341-7. doi: 10.1016/s1471-0153(02)00100-9.
PMID: 15000995
citation: Hou L, Li F, Wang Y, Ou Z, Xu D, Tan W, Dai M. Association between dietary patterns and coronary heart disease: a meta-analysis of prospective cohort studies. Int J Clin Exp Med. 2015 Jan 15;8(1):781-90. eCollection 2015.
PMID: 25785058
citation: Konttinen H, Mannisto S, Sarlio-Lahteenkorva S, Silventoinen K, Haukkala A. Emotional eating, depressive symptoms and self-reported food consumption. A population-based study. Appetite. 2010 Jun;54(3):473-9. doi: 10.1016/j.appet.2010.01.014. Epub 2010 Feb 4.
PMID: 20138944
citation: Lillis J, Niemeier HM, Thomas JG, Unick J, Ross KM, Leahey TM, Kendra KE, Dorfman L, Wing RR. A randomized trial of an acceptance-based behavioral intervention for weight loss in people with high internal disinhibition. Obesity (Silver Spring). 2016 Dec;24(12):2509-2514. doi: 10.1002/oby.21680. Epub 2016 Nov 2.
PMID: 27804255
citation: Oliver G, Wardle J, Gibson EL. Stress and food choice: a laboratory study. Psychosom Med. 2000 Nov-Dec;62(6):853-65. doi: 10.1097/00006842-200011000-00016.
PMID: 11139006
citation: Frayn M, Khanyari S, Knauper B. A 1-day acceptance and commitment therapy workshop leads to reductions in emotional eating in adults. Eat Weight Disord. 2020 Oct;25(5):1399-1411. doi: 10.1007/s40519-019-00778-6. Epub 2019 Sep 20.
PMID: 31541426
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Barbel Knauper
investigator title: James McGill Professor
provided document: 
provided document: 