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临床试验/NCT04432311
NCT04432311已完成不适用

A Randomized Controlled Trial Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of Binge Eating Disorder

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2021年1月5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
164
试验地点
2
主要终点
Binge Eating Symptomology

研究概览

简要总结

Binge eating disorder (BED) is the most common eating disorder in adults, affecting 2.8% of the population. The disorder is characterized by recurrent episodes of binge eating which are not followed by inappropriate compensatory behaviours such as self-induced vomiting. BED is associated with an increased risk of health complications, significant impairment to social and occupational functioning, and reduced quality of life. Despite the negative consequences associated with this disorder, standard therapy for BED is often inaccessible and costly.

To address the limitations of standard therapy for BED our research team has developed Binge Focused Therapy (BFT) as an innovative, guided self-help approach to BED treatment. BFT was derived from elements of "The Brain Over Binge Recovery Guide" by Kathryn Hansen, which incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behaviour Therapy, Motivational Enhancement Therapy, and addictions treatment. We further streamlined this approach into a protocol that can be delivered by non eating disorder specialists (e.g., honours psychology students, nurses, occupational therapists).

In 2018, our research team conducted a proof-of-concept pilot study with a sample of 40 individuals with BED. Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general eating disorder symptomology, and improved confidence in changing binge eating behaviours.

Although the results from this small, uncontrolled, proof-of-concept study are encouraging, qualitative and quantitative data highlighted several aspects of the BFT intervention that could be altered and tested in a randomized controlled trial that compares BFT to an active comparator.

研究设计

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

入排标准

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

入选标准

  • Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnosis of BED (mild-extreme) as per Eating Disorder Examination - Mild severity will be modified from a minimum of 1 objective binge episode/week to 2 objective binge episodes per week
  • Age 18 or older
  • Access to computer with internet connection and webcam that can be used in a private area
  • Virtually signed informed consent form

排除标准

  • Currently receiving psychotherapy/treatment for BED (as determined by PI)
  • Self-reported Body Mass Index on pre-screening questionnaire < 20 kg/m2
  • Dose change of a psychotropic medication used for the treatment of BED (e.g., Vyvanse, topiramate, antidepressants) or any medication that could have an effect on appetite/binging (e.g., Saxenda) within 4 weeks of study inclusion (as determined by PI)
  • Insufficient knowledge of English
  • Previously participated in proof-of-concept BFT study
  • Previously read Overcoming Binge Eating by C. Fairburn and implemented strategies presented in the book (as determined by PI)
  • Serious physical illness (e.g., severe uncontrolled insulin dependent diabetes) (as determined by PI)
  • Currently pregnant
  • Scores greater than 20 on the Quick Inventory of Depressive Symptomatology Self-Report and PI determines participant is significantly depressed (as determined by PI)
  • Currently experiencing serious issues with alcohol or drugs (as determined by PI)
  • Currently engaging in self-harm behaviours (as determined by PI)

结局指标

主要结局

Binge Eating Symptomology

时间窗: Baseline to Post-Treatment (10 week)

This will be measured using the global score generated from the Binge Eating Scale (BES). The BES is a 16-item measure, each item has 3-4 coded responses. The total score ranges from 0-46, where a higher score indicates greater binge eating severity.

次要结局

  • Confidence to Change Binge Eating(Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up)
  • Remission(Week 10, 6-month follow-up, 12-month follow-up)
  • Participant Expectations(Pre-Intervention, Week 1)
  • Satisfaction with Intervention(Week 10)
  • Binge Eating Symptomology(6 week, 6-month follow-up, 12-month follow-up)
  • Clinical Impairment(Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up)
  • Binge Eating Frequency(Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up)
  • Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)(Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up)
  • Abstinence(Week 10, 6-month follow-up, 12-month follow-up)
  • Intervention Adherence(Week 6, Week 10)

研究者

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

Aaron Keshen

Psychiatrist, Principal Investigator

Nova Scotia Health Authority

研究点 (2)

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