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Набор по приглашению NCT04174703

Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

Без фазы С лечением Eating Disorders Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Self-compassionate letter-writing intervention.
Кому может быть актуально
Состояния в реестре: Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder. Базовые параметры: от 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Self-compassionate letter-writing intervention
    Participants in this condition will be asked to engage in an online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks.

Первичные конечные точки

  • Weight- and Body-Related Shame and Guilt Scale (WEB-SG) [Срок оценки: Change from baseline to post-2 weeks of intervention/control condition]
  • Self-compassion Scale (short form; SCS-SF) [Срок оценки: Change from baseline to post-2 weeks of intervention/control condition]
  • Readiness to Change Eating Behaviours [Срок оценки: Change from baseline to post-2 weeks of intervention/control condition]
Вторичные конечные точки (2)
  • Eating Disorder Examination Questionnaire (EDE-Q) [Срок оценки: Change from day 1 to week 25 of group eating disorder treatment]
  • Clinical Impairment Assessment (CIA) [Срок оценки: Change from day 1 to week 25 of group eating disorder treatment]

Критерии участия

Критерии включения

  • 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

Exclusion Criteria: None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • St. Joseph's Healthcare Hamilton — Hamilton

Публикации

  • Kelly AC, Waring SV. A feasibility study of a 2-week self-compassionate letter-writing intervention for nontreatment seeking individuals with typical and atypical anorexia nervosa. Int J Eat Disord. 2018 Aug;51(8):1005-1009. doi: 10.1002/eat.22930. Epub 2018 Aug 13. PMID 30102787
  • Kelly AC, Wisniewski L, Martin-Wagar C, Hoffman E. Group-Based Compassion-Focused Therapy as an Adjunct to Outpatient Treatment for Eating Disorders: A Pilot Randomized Controlled Trial. Clin Psychol Psychother. 2017 Mar;24(2):475-487. doi: 10.1002/cpp.2018. Epub 2016 May 30. PMID 27237928
  • Kelly AC, Carter JC, Zuroff DC, Borairi S. Self-compassion and fear of self-compassion interact to predict response to eating disorders treatment: a preliminary investigation. Psychother Res. 2013;23(3):252-64. doi: 10.1080/10503307.2012.717310. Epub 2012 Aug 24. PMID 22917037

Идентификаторы

NCT: NCT04174703 · 41135

Первоисточники (государственные реестры)

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