Clinical trial NCT06368687: TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum
Official title: Anorexia Nervosa and Autism - a Care Location Adapted for Both Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Autism Spectrum Disorder
Keywords: anorexia nervosa
autism
pilot study
validation
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study. Ten consecutive patients with anorexia nervosa (AN) plus autism will be admitted to the autism care location at an inpatient ward for eating disorders. The planned period of care for each patient is 12 weeks. The patient will be assessed (including weight, height, self-report questionnaires and interviews) before admission, at discharge and 6 months later.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: BMI change between baseline and discharge 12 weeks later
timeFrame: At admission, at discharge 12 weeks later, and 6 months after discharge
Secondary outcomes:
measure: Change of level of anxiety between baseline and discharge 12 weeks later
timeFrame: At admission, at discharge 12 weeks later, and 6 months after discharge
measure: Change of Quality of life between baseline and discharge 12 weeks later
timeFrame: At admission, at discharge 12 weeks later, and 6 months after discharge
Other outcomes:
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