TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum

Официальное название

Anorexia Nervosa and Autism - a Care Location Adapted for Both Conditions

Обзор

In a pilot study, the investigators will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery.

Подробное описание

Anorexia nervosa (AN) is a serious eating disorder and has the highest mortality rate of all psychiatric illnesses. Adolescence is the most common age of onset. Nine out of ten people who fall ill are girls/women, and 2% of all girls/women will fall ill with AN at some point in their lives. In AN, one engages in self-starvation, which in turn leads to underweight. 75 - 80% of individuals with AN recover during adolescence, while the remainder are at high risk of developing chronic AN. For the individual, the chronic condition means great suffering in the form of serious psychiatric and somatic co-morbidity, social isolation and reduced/lack of work ability. People with autism show social withdrawal and reduced flexibility, reminiscent of the symptoms seen in AN. An estimated 15 - 20% of all individuals with AN also have autism. People with AN and concurrent autism run an increased risk of a worse prognosis, as they have more difficulty absorbing treatment, which in itself increases the risk of the condition becoming chronic. Today, there is no scientific evidence for how people with AN and concurrent autism should be treated.

In a pilot study, the investigators will validate a so-called autism care location in our inpatient ward, at Sahlgrenska University Hospital in Gothenburg, Sweden. The care location will be adapted for patients with AN and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery.

Вмешательства

• Другое Anorexia nervosa plus autism
  In the inpatient care the treatment model takes into account the patient's perception disorders, meaning e.g. an adapted mealtime situation where the patient can eat separately or wear hearing protection if necessary. The patients have an adapted meal plan regarding difficulties with specific textures or foods. To meet their need for continuity, they have the same contact persons throughout the entire period of care. The healthcare staff receive training in working with the specific subgroup and

Первичные конечные точки

• BMI change between baseline and discharge 12 weeks later [Срок оценки: At admission, at discharge 12 weeks later, and 6 months after discharge]

Вторичные конечные точки (2)

• Change of level of anxiety between baseline and discharge 12 weeks later [Срок оценки: At admission, at discharge 12 weeks later, and 6 months after discharge]
• Change of Quality of life between baseline and discharge 12 weeks later [Срок оценки: At admission, at discharge 12 weeks later, and 6 months after discharge]

Критерии участия

Критерии включения

• 25 years or older
• Meeting criteria for both anorexia nervosa and autism spectrum disorder according to the DSM-5
• In need of inpatient care due to anorexia nervosa

Критерии исключения

• 24 years or younger
• Not in need of inpatient care due to anorexia nervosa
• Not meeting criteria for both anorexia nervosa and autism spectrum disorder according to the DSM-5

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06368687 · 2023-06112-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗