Online Imaginal Exposure Therapy for Eating Disorders Trial

Официальное название

Efficacy of Online Imaginal Exposure Therapy for Individuals With Anorexia Nervosa

Обзор

The goal of this clinical trial is to learn if an imaginal exposure intervention first conducted by Levinson and colleagues (2020) can produce similar promising results in individuals with anorexia on the waiting list of an NHS eating disorder service. The main question it aims to answer is: 1. How effective is Imaginal Exposure Therapy in reducing eating disorder symptoms and increasing weight in patients with AN? The secondary research questions are: 2. How effective is Imaginal Exposure Therapy in reducing anxiety and fear related outcomes around food and eating? 3. How effective is Imaginal Exposure Therapy in improving patients' general anxiety and depression symptoms? Researchers will compare the results of individuals in the treatment condition to individual's in the control condition to explore the efficacy of the intervention on eating disorder and eating disorder fear symptomology, and body weight. Participants in the intervention group will receive 4 sessions of online exposure therapy, and participants in the control group will remain on the waiting list with treatment as usual (primarily nurse monitoring).

Подробное описание

Study design type: The study will have a parallel group design. Approximately half of the participants will be randomised to receive our intervention, IE for AN. The other half will remain on the waitlist for the service and receive treatment as usual (TAU), which includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs). This study design will allow us to directly assess the efficacy of the IE intervention, as compared to standard waiting list monitoring, on participants' weight and AN symptoms.

Sampling: Potential participants will be identified by the direct care team; any details not obtained through the study questionnaires will be obtained through digital medical records. The researchers will request information where needed through the direct care team. Participants will be recruited through the NELFT ED service post referral triage, while patients are on the waiting list. Participants will be the adults on the waiting list for receiving AN treatment at NELFT.

Procedure: Following informed consent, participation in the trial will last 5 weeks.

Week 1: All participants will, where possible, come to the service in-person to be weighed. All participants will complete a set of psychometric questionnaires during this appointment. The IE group will also complete the Eating Disorder Fear Interview (Levinson et al., 2019), administered in order to identify a fear to target in exposure therapy. If not possible to attend in-person, this primary appointment will be held on Zoom. All baseline appointments will be with a study coordinator.

Week 2: First online imaginal exposure. Week 3: Second online imaginal. Week 4: Third online imaginal exposure. Week 5: Fourth online imaginal exposure and participants will complete the final battery of online questionnaires. They will then come to the service in-person to be weighed again.

Вмешательства

• Другое Imaginal Exposure for Anorexia Nervosa
  Imaginal exposure aims to use the power of imagining the fearful situation to heighten anxiety and by not engaging in imaginative restriction or other eating disorder behaviours, the individual, in theory, can habituate to the anxiety until it naturally subsides.
• Другое Treatment as Usual (TAU)
  TAU includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs)

Первичные конечные точки

• Eating Disorder Examination Questionnaire [Срок оценки: From initial interview till the end of treatment after 5 weeks]
• Body Mass Index [Срок оценки: From initial session until the end of intervention at 5 weeks]

Вторичные конечные точки (5)

• Fear of Food Measure (FOFM) [Срок оценки: From initial session to the end of the intervention at 5 weeks]
• Eating Disorder Fears Interview (EFI) [Срок оценки: From initial session to the end of intervention at 5 weeks]
• Eating Disorder Fears Questionnaire (EFQ) [Срок оценки: From initial session to the end of intervention at 5 weeks]
• Penn State Worry Questionnaire (PSWQ) [Срок оценки: From initial session to end of intervention at 5 weeks.]
• Beck Depression Inventory II (BDI-II) [Срок оценки: From the initial session to the end of the intervention at 5 weeks.]

Критерии участия

Критерии включения

• Patients on the North East London Foundation Trust Eating Disorder waiting list.
• Patients who are over the age of 18 years old.
• Patients of all genders.
• Patients who have a primary diagnosis of Anorexia Nervosa.
• Patients who are willing and able to provide written informed consent.

Критерии исключения

• Patients on the waiting list who are under the age of 18.
• Females who are pregnant, planning pregnancy or breastfeeding.
• Patients involved in concurrent research which is likely to interfere with the imaginal exposure intervention.

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

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• North East London Foundation Trust Eating Disorder Service — London

Публикации

• Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21. PMID 32794449

Идентификаторы

NCT: NCT06818695 · 162510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗