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NCT Number: NCT06368687

TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. BMI change between baseline and discharge 12 weeks later

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

    Body Mass Index: weight (kilograms)/height (meters)2

Secondary outcomes

  1. Change of level of anxiety between baseline and discharge 12 weeks later

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

    Anxiety assessed using General Anxiety Disorder 7-item (GAD-7)

  2. Change of Quality of life between baseline and discharge 12 weeks later

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

    Quality of life (QoL) assessed using Short Form Health Survey (SF-36)

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabet Wentz, PhD

CONTACT

[email protected]

0046-707181666

Peter Goldberg

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: TRANPAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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