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临床试验/NCT04433663
NCT04433663已完成不适用

Eating Disorders, Emotion Regulation, and Mentalization: Addressing the Gap Between Theory and Practice

Tel Hai College2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Eating Attitudes Test (EAT-26)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The research student, who collected the data was blind to treatment groups. Therapists and participants were blinded to the research aims and hypothesis.

入排标准

年龄范围
17 Years 至 30 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Eating Attitudes Test (EAT-26)

时间窗: 1 year

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.

Reflective Functioning Questionnaire RFQ

时间窗: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moria Golan

Prof.

Tel Hai College

研究点 (2)

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