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临床试验/NCT05539807
NCT05539807Enrolling By Invitation不适用

Short and Long-term Changes in Eating Disorder Symptoms During and After a Low-threshold Mindfulness-based Intervention Administered by a Self-help Organization in Norway

University of Bergen2 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
197
试验地点
2
主要终点
Change in eating disorder symptoms measured by Eating Disorder Examination Questionnaire (EDE-Q)

研究概览

简要总结

This prospective one-arm study aims to examine short and long-term changes in dysfunctional eating among individuals who signed up for an 8-week, group based, low threshold, mindfulness-based intervention. The study is an extension of a quality assurance project which was provided by a nation-wide self-help organization for people with self-identified eating problems. Eating disorder symptoms and the proposed predictors (self-kindness, self-judgment and mindfulness) were registered online at 12 measurement time points. In the current study we will invite the same participants to complete the same measures four years after the intervention.

详细描述

Recent literature-reviews suggest that mindfulness-based interventions may be effective in treating problems related to dysfunctional eating such as binge eating and emotional eating. Less is known about the processes through which change happens. Moreover, long-term follow-up is scarce. The main aim of the current project is to examine the role of self-kindness and self-judgement in predicting changes in eating disorder symptoms four years after, and to analyze longitudinal data for the entire project. Measures were administrated before the intervention, each week during the intervention, after the intervention, at follow-up 6 months after the intervention and at a second follow up four years after the intervention.

The intervention is an 8-week mindfulness-based eating program (Mindful Eating Conscious Living). This intervention was administered by a nation-wide Norwegian self-help eating disorder organization. Participants who enrolled in the program (N=197) were asked to complete standardized self-report instruments at recruitment (T1), digitally during each of the 8-week sessions (T2-T9), after the intervention was completed (T10) and six months after the intervention was completed (T11).

The current study - a PhD project - will invite the same participants to complete the same measures four years after completing the program. This will provide a rich data set, collected over four years.

The main hypotheses are:

Self-kindness and self-judgment as predictors of ED symptoms

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identifying as having a binge-eating related problem and being 16 years or older.

排除标准

  • High suicidal risk, serious self-harm, active psychosis, active major depressive episode, anorexia nervosa, BMI < 18, or debilitating social anxiety.

结局指标

主要结局

Change in eating disorder symptoms measured by Eating Disorder Examination Questionnaire (EDE-Q)

时间窗: Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up

A self-report questionnaire measuring eating disorder symptoms by Fairburn and colleagues

Change in self-kindness, self-judgement and mindfulness from the Self-compassion scale

时间窗: Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up

Subscales from the self-compassion scale of Kristin Neff and colleagues. Self-kindness indicates the tendency to respond with kindness to own feelings of distress and failure (e.g. I try to be understanding and patient towards those aspects of my personality I don't like). Self-judgment indicates the tendency to respond with self-judgment to own feelings of distress and failure (self-judgment, e.g. I'm disapproving and judgmental about my own flaws and inadequacies). Mindfulness indicates the tendency to respond with balanced awareness to own feelings of distress and failure. E.g.: "When something painful happens I try to take a balanced view of the situation".

次要结局

  • Change in mindful eating as measured by the Mindful Eating Questionnaire(Pre, post, 6 months follow up, four-years follow-up)
  • Change in relationship and life Satisfaction(Pre, post, 6 months follow up, four-years follow-up)

研究者

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

Ingrid Dundas

Associate Professor

University of Bergen

研究点 (2)

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