Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

Официальное название

Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

Обзор

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.

Вмешательства

• Поведенческое Online Guided Self-Help-Family-based Treatment
  GSH-FBT consists of 10 20-minute sessions for parents only over 9 months. Sessions follow an online curriculum of 65 short videos: 62 with an expert clinician instructing parents on the principles of FBT, and 3 reflections from an adolescent who recovered from AN and completed FBT. Each lecture series contains an introduction orienting the viewer to the videos, 5-9 short videos (\< 7 minutes each), and assigned reading from the parent education manual Help Your Teenager Beat an Eating Disorder.
• Поведенческое FBT via Videoconferencing
  15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focu

Первичные конечные точки

• Ratio of therapist hours to %EBW change [Срок оценки: Assessed from baseline through end of treatment (EOT)]

Вторичные конечные точки (3)

• Eating Disorder Examination (EDE) [Срок оценки: Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up]
• Beck Depression Inventory (BDI) [Срок оценки: These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up)]
• Beck Anxiety Inventory (BAI) [Срок оценки: Baseline, sessions 2, 4, 6, 8, and EOT]

Критерии участия

Критерии включения

• Participants are 12-18 years of age
• Participants live with a family (some families may contain only one parent)
• Family members fluently speak and read English and have access to a computer with internet
• Participants meet DSM-5 criteria for AN (both subtypes)
• EBW above 75%
• Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
• Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
• Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.

Критерии исключения

Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.

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

США · 1 центр

• Stanford University — Stanford

Канада · 1 центр

• McMaster University — Hamilton

Публикации

• Gurcan H, Couturier J, Matheson B, Jo B, Lock J. Protocol for a randomized clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa. Contemp Clin Trials. 2024 Sep;144:107618. doi: 10.1016/j.cct.2024.107618. Epub 2024 Jul 4. PMID 38971303

Идентификаторы

NCT: NCT05563649 · 67295 · R01MH130388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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