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临床试验/NCT04174703
NCT04174703Enrolling By Invitation不适用

Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

University of Waterloo1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
160
试验地点
1
主要终点
Weight- and Body-Related Shame and Guilt Scale (WEB-SG)

研究概览

简要总结

Compassion-focused therapy (CFT) seeks to lower shame and help people develop compassion for personal distress and shortcomings. There is increasing evidence to support the benefits of incorporating CFT-based interventions into the treatment of eating disorders (EDs). Building on the investigators' prior research, this study will examine the effects of a two-week CFT-based self-compassion letter-writing intervention on patients with eating disorders. Participants will be recruited from the wait-list of patients scheduled to begin treatment at the outpatient St. Joseph's Healthcare Hamilton Eating Disorders Program, and will be randomly assigned to the two-week letter-writing intervention or to a control group. Results will inform the integration of new empirically-derived interventions into ED treatments to improve the currently dismal rates of ED recovery.

详细描述

The study consists of two phases. In phase one, participants will be randomly assigned to a two-week daily letter-writing intervention condition or a two-week control condition; phase one will occur two to four weeks prior to the start date of group ED treatment. Participants will complete a brief set of online questionnaires pre-, mid-, and post- two-week condition (i.e. baseline, after one week, and after two weeks).

Following these two weeks of intervention/control condition, all participants will complete a 25-week group treatment program as scheduled by the Eating Disorders Program. For phase two of the study, participants will be asked to complete questionnaires after 5 weeks, after 11 weeks, and post-group treatment. Data that is routinely collected as part of patients' clinical care pre- and post-treatment (i.e. on the first day and last week of group treatment) will also be collected.

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
Single (Care Provider)

盲法说明

The care providers will not be told which condition each participant was assigned to.

入排标准

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

入选标准

  • DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
  • Eligible to start group eating disorders treatment at St. Joseph's Eating Disorder Program
  • 17 years of age or older

排除标准

  • 未提供

研究组 & 干预措施

Control condition

No Intervention

Self-compassionate letter-writing intervention

Experimental

An online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks

干预措施: Self-compassionate letter-writing intervention (Other)

结局指标

主要结局

Weight- and Body-Related Shame and Guilt Scale (WEB-SG)

时间窗: Change from baseline to post-2 weeks of intervention/control condition

Self-report questionnaire with 12 questions on a 5-point Likert scale (scored 0-4). Total scores range from 0-48, with higher decrease in score indicative of a better outcome (i.e. higher decrease in levels of shame and guilt).

Readiness to Change Eating Behaviours

时间窗: Change from baseline to post-2 weeks of intervention/control condition

Self-report questionnaire with 3 questions on a 10-point Likert scale (scored 1-10). Total scores range from 3-30, with higher increase in score indicative of a better outcome (i.e. higher increase in readiness to change disordered eating behaviours).

Self-compassion Scale (short form; SCS-SF)

时间窗: Change from baseline to post-2 weeks of intervention/control condition

Self-report questionnaire with 12 questions on a 5-point Likert scale (scored 1-5). Total scores range from 12-60, with higher increase in score indicative of a better outcome (i.e. higher increase in levels of self-compassion).

次要结局

  • Eating Disorder Examination Questionnaire (EDE-Q)(Change from day 1 to week 25 of group eating disorder treatment)
  • Clinical Impairment Assessment (CIA)(Change from day 1 to week 25 of group eating disorder treatment)

研究者

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

Allison Kelly

Associate Professor

University of Waterloo

研究点 (1)

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