<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/NCT04433663</url>
  </required_header>
  <id_info>
    <org_study_id>TelHaiC</org_study_id>
    <nct_id>NCT04433663</nct_id>
  </id_info>
  <brief_title>Eating Disorders, Self Regulation and Mentalization</brief_title>
  <official_title>Eating Disorders, Emotion Regulation, and Mentalization: Addressing the Gap Between Theory and Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Hai College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel Hai College</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>
      A randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the&#xD;
      Reflective Functioning Questionnaire RFQ - as the main outcome to assess two interventions&#xD;
      for eating disorders. Six experienced therapists, and their consecutively 8-9 admitted&#xD;
      clients, were randomly allocated to the intervention group and control group. The sample&#xD;
      included a total of 52 participants, all women, mean age 24.2 yrs. old. In the intervention&#xD;
      group, participants received mentalization-based psychotherapy with ECOSA - a novel developed&#xD;
      mentalization tool and in the control group, participants received interpersonal&#xD;
      psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. Four&#xD;
      randomized samples for each participant were checked for therapy-focused fidelity by two&#xD;
      different psychotherapists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one&#xD;
      eating disorder center, were randomly allocated using the excel randomization function to the&#xD;
      intervention group and control group. All participants in the clinical sample were drawn&#xD;
      consecutively from admitted population to these therapists in a community-based eating&#xD;
      disorder center between September 2018 to April 2019. The sample (total of 52 patients)&#xD;
      included 26 participants in each group, all women, (mean age 24.2±3.2). Forty two percent of&#xD;
      participants in each group were diagnosed with BN, 13% with BED, 35% with AN and 10% with&#xD;
      ARFID. Thirty percent of participants in each group, also met criteria for borderline&#xD;
      personality disorder on the SCID-II .The overall sample had predominantly high socioeconomic&#xD;
      status.&#xD;
&#xD;
      Each therapist received a written consent from 8 to 9 clients to participate in the study and&#xD;
      record all sessions. The research student, who collected the data was blind to treatment&#xD;
      groups. Therapists and participants were blinded to the research aims and hypothesis.&#xD;
&#xD;
      In the intervention group, therapist received mentalization-based supervision along all&#xD;
      participants' treatments, with the suggested tool and facilitated mentalization-focused&#xD;
      therapy. The control group's participants received ITP-interpersonal psychotherapy that&#xD;
      focused on resolving interpersonal problems and symptomatic recovery. The control group's&#xD;
      therapist received regular supervision - with no emphasis on mentalization or tool's usage.&#xD;
&#xD;
      Participants' sessions were recorded over 12 months of treatment. Four randomized samples for&#xD;
      each participant were checked for therapy-focused fidelity by two different psychotherapist&#xD;
      Measures All participants underwent on entry a standard assessment of eating disorder,&#xD;
      including a semi structured interview to measure co-morbid disorders, by experienced&#xD;
      psychologist. Participants in both groups completed the Eating Attitudes Test (EAT-26) and&#xD;
      the Reflective Functioning Questionnaire RFQ as part of a larger assessment battery.&#xD;
&#xD;
      The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It&#xD;
      consists of 26 items with six components scored from 0 to 3 (Zero: &quot;Never,&quot; &quot;Rarely,&quot; and&#xD;
      &quot;Sometimes&quot;; 1: &quot;Often&quot;; 2: &quot;Very often&quot;; and 3: &quot;Always&quot;). The total score range from 0 to&#xD;
      78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors. The&#xD;
      Cronbach's alpha in this study ranged between 0.75-0.90.&#xD;
&#xD;
      The RFQ was developed as a brief, easy-to-administer screening measure to assess severe&#xD;
      impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point&#xD;
      Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty&#xD;
      about mental states, hence difficulties with mentalizing. The Cronbach's alpha in this study&#xD;
      ranged between 0.8-0.94.&#xD;
&#xD;
      Statistical analysis All analyses were conducted using SPSS 23®. Normality distributions and&#xD;
      outliers for each outcome variable were examined prior to commencing analysis. Independent&#xD;
      T-tests analysis was used to assess differences between groups at baseline and between&#xD;
      groups' improvements. Paired T-tests within each group used to assess the improvement between&#xD;
      baseline, and 12 months treatment. Pearson correlations were computed to assess the&#xD;
      relationship between change in eating disorder's symptoms and change in mentalizing&#xD;
      capacities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2018</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one eating disorder center, were randomly allocated using the excel randomization function to the intervention group and control group. All participants in the clinical sample were drawn consecutively from admitted population to these therapists in a community-based eating disorder center between September 2018 to April 2019.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The research student, who collected the data was blind to treatment groups. Therapists and participants were blinded to the research aims and hypothesis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reflective Functioning Questionnaire RFQ</measure>
    <time_frame>1 year</time_frame>
    <description>The RFQ was developed as a brief, easy-to-administer screening measure to assess severe impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty about mental states, hence difficulties with mentalizing (Fonagy, Luyten, Moulton-Perkins, Lee, Warren et al, 2016). The Cronbach's alpha in this study ranged between 0.8-0.94.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating Attitudes Test (EAT-26)</measure>
    <time_frame>1 year</time_frame>
    <description>The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: &quot;Never,&quot; &quot;Rarely,&quot; and &quot;Sometimes&quot;; 1: &quot;Often&quot;; 2: &quot;Very often&quot;; and 3: &quot;Always&quot;). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors (Garner, 1991). The Cronbach's alpha in this study ranged between 0.75-0.90.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Mentalization-based Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention group, received mentalization-based psychotherapy with the developed ECOSA axis. Therapist received mentalization-based supervision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPT-Inter Personal Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group's participants received IPT - interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. The control group's therapist received regular supervision - with no emphasis on mentalization or tool's usage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis</intervention_name>
    <description>To address the gap between theory and practice in the treatment of eating disorders we y developed a novel axis, ECOSA, to better conceptualize the complex interaction between eating style, control conditions, and the impact of the &quot;emotional brain&quot; versus the &quot;thinking brain&quot;. A randomized pilot study was used to evaluate the integration of this tool in a mentalization-based treatment compared to treatment as usual (IPT).&#xD;
Methods: The suggested tool was tested in a randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome.</description>
    <arm_group_label>IPT-Inter Personal Therapy</arm_group_label>
    <arm_group_label>Mentalization-based Intervention</arm_group_label>
    <other_name>IPT - interpersonal psychotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Participants were previously diagnosed with eating disorder (Eat-26&gt;21)&#xD;
&#xD;
          -  17 yrs age and older&#xD;
&#xD;
          -  no acute suicidality&#xD;
&#xD;
          -  no physical risks due to eating disorder's symptoms&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  age &lt;17 yrs old&#xD;
&#xD;
          -  refusal to corporate with treatment&#xD;
&#xD;
          -  Need of 24 hrs medical care&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Academic College of Tel Hai</name>
      <address>
        <city>Kiryat Shmona</city>
        <state>North Of Israel</state>
        <zip>1220800</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Fonagy, P., Gergely, G., Jurist, E. L., &amp; Target, M. (2018). Affect regulation, mentalization and the development of the self. Taylor and Francis Inc. https://doi.org/10.4324/9780429471643</citation>
  </reference>
  <reference>
    <citation>Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.</citation>
    <PMID>27392018</PMID>
  </reference>
  <reference>
    <citation>Garner, D. (1991). The Eating Disorder Inventory-2: Professional Manual. Odessa, Florida: Psychological Assessment Resources.</citation>
  </reference>
  <reference>
    <citation>Juarascio, A., Manasse, S., Clark, K. E., Schaumberg, K., Kerrigan, S., Goldstein, S. P., &amp; Forman, E. (2020). Understanding the overlap and differences in terms describing patterns of maladaptive avoidance and intolerance of negative emotional states. Personality and Individual Differences. Elsevier Ltd. https://doi.org/10.1016/j.paid.2020. 109859.</citation>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Hai College</investigator_affiliation>
    <investigator_full_name>Moria Golan</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>eating disorders</keyword>
  <keyword>self-regulation</keyword>
  <keyword>self-control</keyword>
  <keyword>Mentalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All names and identification data will be omitted from the file that will be sent to statistical assessments.</ipd_description>
  </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/NCT04433663
org study id: TelHaiC
nct id: NCT04433663
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the
      Reflective Functioning Questionnaire RFQ - as the main outcome to assess two interventions
      for eating disorders. Six experienced therapists, and their consecutively 8-9 admitted
      clients, were randomly allocated to the intervention group and control group. The sample
      included a total of 52 participants, all women, mean age 24.2 yrs. old. In the intervention
      group, participants received mentalization-based psychotherapy with ECOSA - a novel developed
      mentalization tool and in the control group, participants received interpersonal
      psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. Four
      randomized samples for each participant were checked for therapy-focused fidelity by two
      different psychotherapists.
Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one
      eating disorder center, were randomly allocated using the excel randomization function to the
      intervention group and control group. All participants in the clinical sample were drawn
      consecutively from admitted population to these therapists in a community-based eating
      disorder center between September 2018 to April 2019. The sample (total of 52 patients)
      included 26 participants in each group, all women, (mean age 24.2±3.2). Forty two percent of
      participants in each group were diagnosed with BN, 13% with BED, 35% with AN and 10% with
      ARFID. Thirty percent of participants in each group, also met criteria for borderline
      personality disorder on the SCID-II .The overall sample had predominantly high socioeconomic
      status.

      Each therapist received a written consent from 8 to 9 clients to participate in the study and
      record all sessions. The research student, who collected the data was blind to treatment
      groups. Therapists and participants were blinded to the research aims and hypothesis.

      In the intervention group, therapist received mentalization-based supervision along all
      participants' treatments, with the suggested tool and facilitated mentalization-focused
      therapy. The control group's participants received ITP-interpersonal psychotherapy that
      focused on resolving interpersonal problems and symptomatic recovery. The control group's
      therapist received regular supervision - with no emphasis on mentalization or tool's usage.

      Participants' sessions were recorded over 12 months of treatment. Four randomized samples for
      each participant were checked for therapy-focused fidelity by two different psychotherapist
      Measures All participants underwent on entry a standard assessment of eating disorder,
      including a semi structured interview to measure co-morbid disorders, by experienced
      psychologist. Participants in both groups completed the Eating Attitudes Test (EAT-26) and
      the Reflective Functioning Questionnaire RFQ as part of a larger assessment battery.

      The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It
      consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and
      "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to
      78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors. The
      Cronbach's alpha in this study ranged between 0.75-0.90.

      The RFQ was developed as a brief, easy-to-administer screening measure to assess severe
      impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point
      Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty
      about mental states, hence difficulties with mentalizing. The Cronbach's alpha in this study
      ranged between 0.8-0.94.

      Statistical analysis All analyses were conducted using SPSS 23®. Normality distributions and
      outliers for each outcome variable were examined prior to commencing analysis. Independent
      T-tests analysis was used to assess differences between groups at baseline and between
      groups' improvements. Paired T-tests within each group used to assess the improvement between
      baseline, and 12 months treatment. Pearson correlations were computed to assess the
      relationship between change in eating disorder's symptoms and change in mentalizing
      capacities.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Six experienced therapists (more than 10 yrs. in the eating disorders' treatment) within one eating disorder center, were randomly allocated using the excel randomization function to the intervention group and control group. All participants in the clinical sample were drawn consecutively from admitted population to these therapists in a community-based eating disorder center between September 2018 to April 2019.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The research student, who collected the data was blind to treatment groups. Therapists and participants were blinded to the research aims and hypothesis.
measure: Reflective Functioning Questionnaire RFQ
time frame: 1 year
description: The RFQ was developed as a brief, easy-to-administer screening measure to assess severe impairments or imbalances in mentalization capacities. It includes 8 items scaled on 7-point Likert-type scale scored from 0 to 3. High values on this scale indicate high uncertainty about mental states, hence difficulties with mentalizing (Fonagy, Luyten, Moulton-Perkins, Lee, Warren et al, 2016). The Cronbach's alpha in this study ranged between 0.8-0.94.
measure: Eating Attitudes Test (EAT-26)
time frame: 1 year
description: The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors (Garner, 1991). The Cronbach's alpha in this study ranged between 0.75-0.90.
arm group label: Mentalization-based Intervention
arm group type: Experimental
description: Participants in the intervention group, received mentalization-based psychotherapy with the developed ECOSA axis. Therapist received mentalization-based supervision.
arm group label: IPT-Inter Personal Therapy
arm group type: Active Comparator
description: The control group's participants received IPT - interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. The control group's therapist received regular supervision - with no emphasis on mentalization or tool's usage.
intervention type: Other
intervention name: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis
description: To address the gap between theory and practice in the treatment of eating disorders we y developed a novel axis, ECOSA, to better conceptualize the complex interaction between eating style, control conditions, and the impact of the "emotional brain" versus the "thinking brain". A randomized pilot study was used to evaluate the integration of this tool in a mentalization-based treatment compared to treatment as usual (IPT).
Methods: The suggested tool was tested in a randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome.
arm group label: IPT-Inter Personal Therapy
arm group label: Mentalization-based Intervention
other name: IPT - interpersonal psychotherapy
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 30 Years
healthy volunteers: No
facility: 
country: Israel
citation: Fonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2018). Affect regulation, mentalization and the development of the self. Taylor and Francis Inc. https://doi.org/10.4324/9780429471643
citation: Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
PMID: 27392018
citation: Garner, D. (1991). The Eating Disorder Inventory-2: Professional Manual. Odessa, Florida: Psychological Assessment Resources.
citation: Juarascio, A., Manasse, S., Clark, K. E., Schaumberg, K., Kerrigan, S., Goldstein, S. P., & Forman, E. (2020). Understanding the overlap and differences in terms describing patterns of maladaptive avoidance and intolerance of negative emotional states. Personality and Individual Differences. Elsevier Ltd. https://doi.org/10.1016/j.paid.2020. 109859.
responsible party type: Principal Investigator
investigator affiliation: Tel Hai College
investigator full name: Moria Golan
investigator title: Prof.
mesh term: Feeding and Eating Disorders
sharing ipd: No
ipd description: All names and identification data will be omitted from the file that will be sent to statistical assessments.