Anorexia NervosaTRANPASNCT06368687
TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum
A study testing Anorexia nervosa plus autism in people with Anorexia Nervosa and Autism Spectrum Disorder, run by Göteborg University.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Anorexia Nervosa, Autism Spectrum Disorder
- What is being tested?
- Anorexia nervosa plus autism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Peter Goldberg contact
About this study
Official title: Anorexia Nervosa and Autism - a Care Location Adapted for Both Conditions
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.
Read the 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.
- Conditions
- Anorexia Nervosa, Autism Spectrum Disorder
- Being tested
- Anorexia nervosa plus autism
- Keywords
- anorexia nervosa, autism, pilot study, validation
- Medical subject headings
- Anorexia Nervosa, Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anorexia nervosa plus autismOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Anorexia nervosa plus autism |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI change between baseline and discharge 12 weeks later
Body Mass Index: weight (kilograms)/height (meters)2
Measured: 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
Anxiety assessed using General Anxiety Disorder 7-item (GAD-7)
Measured: At admission, at discharge 12 weeks later, and 6 months after discharge
Change of Quality of life between baseline and discharge 12 weeks later
Quality of life (QoL) assessed using Short Form Health Survey (SF-36)
Measured: At admission, at discharge 12 weeks later, and 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368687
- Sponsor's protocol ID
- 2023-06112-01
- Other IDs
- 2023
- Acronym
- TRANPAS
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorexia Nervosa and Autism - a Care Location Adapted for Both Conditions
- ClinicalTrials.gov ID
- NCT06368687
- Acronym / sponsor ID
- TRANPAS / 2023-06112-01
- Conditions
- Anorexia Nervosa, Autism Spectrum Disorder
- Keywords
- anorexia nervosa, autism, pilot study, validation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa plus autism | Other | Other: Anorexia nervosa plus autismThe 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anorexia nervosa plus autismIn 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. | Other | Anorexia nervosa plus autism |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Goldberg contact
Questions about this trial
What is this clinical trial studying?
A study testing Anorexia nervosa plus autism in people with Anorexia Nervosa and Autism Spectrum Disorder, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabet Wentz, PhD (0046-707181666, elisabet.wentz@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI change between baseline and discharge 12 weeks later (time frame: At admission, at discharge 12 weeks later, and 6 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.