TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum

NCT06368687 | Not Yet Recruiting

• 1 other identifier: 2023-06112-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anorexia Nervosa; Autism Spectrum Disorder

Keywords

anorexia nervosa; autism; pilot study; validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of level of anxiety between baseline and discharge 12 weeks later

  At admission, at discharge 12 weeks later, and 6 months after discharge

• Change of Quality of life between baseline and discharge 12 weeks later

  At admission, at discharge 12 weeks later, and 6 months after discharge

Study Arms (1)

Anorexia nervosa plus autism

OTHER

The treatment model takes into account the patient's perception disorders. This means 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.

Other: Anorexia nervosa plus autism

Interventions

Anorexia nervosa plus autism OTHER

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.

Anorexia nervosa plus autism

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

MeSH Terms

Conditions

Anorexia Nervosa; Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Central Study Contacts

Elisabet Wentz, PhD

CONTACT

0046-707181666; elisabet.wentz@gu.se

Peter Goldberg

CONTACT

peter.goldberg@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04