Eating Disorders, Self Regulation and Mentalization

NCT04433663 | Completed

• 1 other identifier: TelHaiC
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders

Keywords

eating disorders; self-regulation; self-control; Mentalization

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Study Arms (2)

Mentalization-based Intervention

EXPERIMENTAL

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

Other: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis

IPT-Inter Personal Therapy

ACTIVE COMPARATOR

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.

Other: Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis

Interventions

Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis OTHER

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.

Also known as: IPT - interpersonal psychotherapy

IPT-Inter Personal Therapy; Mentalization-based Intervention

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel Hai College: lead

Study Sites (1)

Academic College of Tel Hai

Kiryat Shmona, North of Israel, 1220800, Israel

Location

Related Publications (4)

• 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

  BACKGROUND

• 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 BACKGROUND

• Garner, D. (1991). The Eating Disorder Inventory-2: Professional Manual. Odessa, Florida: Psychological Assessment Resources.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Self-Control

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The research student, who collected the data was blind to treatment groups. Therapists and participants were blinded to the research aims and hypothesis.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 16, 2020
• Study Start: September 2, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)