Eating Disorders, Self Regulation and Mentalization

NCT ID: NCT04433663

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-02
• Study Completion Date: 2020-05-01

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.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mentalization-based Intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

IPT-Inter Personal Therapy

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Other Intervention Names

IPT - interpersonal psychotherapy

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel Hai College

OTHER

Sponsor Role: lead

Responsible Party

Moria Golan

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Academic College of Tel Hai

Kiryat Shmona, North of Israel, Israel

Countries

Israel

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 27392018 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

Other Identifiers

TelHaiC

Identifier Type: -

Identifier Source: org_study_id