TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum

Autism Spectrum Disorder Clinical Trial

— TRANPAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368687
• Other study ID #: 2023-06112-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Göteborg University
• Contact: Elisabet Wentz, PhD
• Phone: +46707181666
• Email: elisabet.wentz[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a pilot study, we 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.

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, we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• 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 have regular exchanges of experience regarding the patient group, 15 minutes every or every two weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI change between baseline and discharge 12 weeks later	Body Mass Index: weight (kilograms)/height (meters)2	At admission, at discharge 12 weeks later, and 6 months after discharge
Secondary	Change of level of anxiety between baseline and discharge 12 weeks later	Anxiety assessed using General Anxiety Disorder 7-item (GAD-7)	At admission, at discharge 12 weeks later, and 6 months after discharge
Secondary	Change of Quality of life between baseline and discharge 12 weeks later	Quality of life (QoL) assessed using Short Form Health Survey (SF-36)	At admission, at discharge 12 weeks later, and 6 months after discharge