A Randomized Controlled Study of a Dialectical Behavior Therapy Guided Self-Help Intervention for Binge Eating Disorder
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
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
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
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
Jacqueline Carter-Major
Associate Professor
Memorial University of Newfoundland
