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临床试验/NCT02834299
NCT02834299已完成不适用

A Randomized Controlled Study of a Dialectical Behavior Therapy Guided Self-Help Intervention for Binge Eating Disorder

Memorial University of Newfoundland1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Eating Disorder Examination Questionnaire

研究概览

简要总结

This study will compare unguided and guided dialectical behavior therapy (DBT) self-help to an attention-placebo self-help control condition. Participants with binge eating disorder will be randomly assigned to one of the three self-help conditions for 12 weeks. Six guided self-help sessions will take place via secure video-calling. Assessments will take place before, mid-way through, and after the self-help program as well as at 3-month follow-up. Six guided self-help sessions will take place via secure video-calling.

详细描述

STUDY OBJECTIVES AND HYPOTHESES The primary objective of this randomized controlled trial is to compare the effectiveness of two methods of administering a dialectical behavior therapy (DBT) self-help intervention in a community sample of individuals with BED in NL: guided DBT self-help (DBT-GSH) and unguided DBT self-help (DBT-USH). A third condition designed to control for non-specific or common factors (e.g., receiving a self-help book) will also be included (NS-SH). This condition will be a self-help manual focused on improving low self-esteem using CBT strategies with no reference to binge eating.

METHODS

Sample size calculation:

Power analysis was based on the primary outcome variable: frequency of binge eating episodes. Assuming the three randomized groups (DBT-USH, DBT-GSH and NS-UGS) are equivalent at baseline, a between groups ANOVA will be used to compare them at post-treatment. Based on the findings of Masson et al. (2014), assuming an effect size of 0.40 and Type 1 error rate equal to .05, a sample size of at least 21 participants per group will yield 80% power. Assuming an attrition rate of 20%, we will require 25 participants per group.

Procedure:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •meets DSM 5 criteria for binge eating disorder (BED)

排除标准

  • •receiving specialized psychological treatment for BED,
  • •BMI under 18.5,
  • •substance use disorder, major medical illness, psychotic symptoms

研究组 & 干预措施

DBT Guided Self-Help

Experimental

Participants will be provided with the DBT self-help manual "Dialectical Behavior Therapy for Binge Eating: A Self-Help Program" by Safer, Adler & Masson (2016) and receive six brief therapy sessions via video-calling.

干预措施: DBT Guided Self-Help (Behavioral)

DBT Unguided Self-Help

Experimental

Participants will be provided with the DBT self-help manual "Dialectical Behavior Therapy for Binge Eating: A Self-Help Program" by Safer, Adler & Masson (2016) and asked to follow the manual on their own.

干预措施: DBT Unguided Self-Help (Behavioral)

Self-Esteem-Focused Unguided Self-Help

Active Comparator

Participants will be provided with the self-help manual "Self-Esteem" by McKay & Fanning (2016) as asked to follow the manual on their own.

干预措施: Self-Esteem-Focused Unguided Self-Help (Behavioral)

结局指标

主要结局

Eating Disorder Examination Questionnaire

时间窗: Change from baseline at Week 12

measures core eating disorder psychopathology and binge eating

次要结局

  • Difficulties in Emotion Regulation Scale(Change from baseline at Week 12)
  • Brief Symptom Inventory(Change from baseline at Week 12)

研究者

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

Jacqueline Carter-Major

Associate Professor

Memorial University of Newfoundland

研究点 (1)

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