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Eating Disorders, Self Regulation and Mentalization

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis
Sponsored by
Tel Hai College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring eating disorders, self-regulation, self-control, Mentalization

Eligibility Criteria

17 Years - 30 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • Participants were previously diagnosed with eating disorder (Eat-26>21)
  • 17 yrs age and older
  • no acute suicidality
  • no physical risks due to eating disorder's symptoms

Exclusion criteria:

  • age <17 yrs old
  • refusal to corporate with treatment
  • Need of 24 hrs medical care

Sites / Locations

  • Academic College of Tel Hai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mentalization-based Intervention

IPT-Inter Personal Therapy

Arm Description

Participants in the intervention group, received mentalization-based psychotherapy with the developed ECOSA axis. Therapist received mentalization-based supervision.

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.

Outcomes

Primary Outcome Measures

Reflective Functioning Questionnaire RFQ
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.
Eating Attitudes Test (EAT-26)
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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2020
Last Updated
October 6, 2020
Sponsor
Tel Hai College
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1. Study Identification

Unique Protocol Identification Number
NCT04433663
Brief Title
Eating Disorders, Self Regulation and Mentalization
Official Title
Eating Disorders, Emotion Regulation, and Mentalization: Addressing the Gap Between Theory and Practice
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Hai College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
eating disorders, self-regulation, self-control, Mentalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mentalization-based Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention group, received mentalization-based psychotherapy with the developed ECOSA axis. Therapist received mentalization-based supervision.
Arm Title
IPT-Inter Personal Therapy
Arm Type
Active Comparator
Arm 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(s)
Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis
Other Intervention Name(s)
IPT - interpersonal psychotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Reflective Functioning Questionnaire RFQ
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.
Time Frame
1 year
Title
Eating Attitudes Test (EAT-26)
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants were previously diagnosed with eating disorder (Eat-26>21) 17 yrs age and older no acute suicidality no physical risks due to eating disorder's symptoms Exclusion criteria: age <17 yrs old refusal to corporate with treatment Need of 24 hrs medical care
Facility Information:
Facility Name
Academic College of Tel Hai
City
Kiryat Shmona
State/Province
North Of Israel
ZIP/Postal Code
1220800
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All names and identification data will be omitted from the file that will be sent to statistical assessments.
Citations:
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
Results Reference
background
PubMed Identifier
27392018
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.
Results Reference
background
Citation
Garner, D. (1991). The Eating Disorder Inventory-2: Professional Manual. Odessa, Florida: Psychological Assessment Resources.
Results Reference
background
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.
Results Reference
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Eating Disorders, Self Regulation and Mentalization

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