Tests a digital program for adults with autism spectrum disorder
Tests whether the autimia digital program helps adults with autism manage daily life.
Plain-language title generated from the registry record
Registry title: Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder
Key facts
- Where
- Hamburg, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with autism spectrum disorder who feel psychological distress and keep their usual treatment. Some use the digital programme autimia for six months.
- Age
- 18 Years to 65 Years
- Sex
- All sexes can join.
- Disease stage
- Autism spectrum disorder (ICD-10 codes F84.5, F84.0, F84.1) confirmed in a video-call interview, IQ of 80 or more, and increased psychological distress (DASS-21 total score of 21 or more).
- Earlier treatment
- Stable treatment (medication, psychotherapy or no treatment) for at least 30 days before joining.
Main reasons for not taking part
- Plans to change treatment in the 3 months after joining
- Another severe psychiatric disorder (for example acute psychotic disorder or borderline personality disorder)
- Acute suicidality
- Legal guardianship for healthcare decisions
- Not enough German or basic IT skills
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07638657, who can take part
Where in Germany
- GAIA AGHamburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gaia AG
- Trial code
- NCT07638657
- Record updated
- 16 June 2026
- Original description
The goal of this clinical trial is to find out if autimia, a digital health intervention, can help adults with ASD (Autism Spectrum Disorder) manage their daily lives and improve their well-being.Read full original descriptionShow less
Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico Trial)
The goal of this clinical trial is to find out if autimia, a digital health intervention, can help adults with ASD (Autism Spectrum Disorder) manage their daily lives and improve their well-being.
The main questions it aims to answer are:
* Does autimia, together with regular treatment, improve health outcomes after three months better than regular treatment alone? * Are the positive effects of autimia still noticeable after six months?
Researchers will compare two groups:
* Intervention group: Participants use the autimia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only.
Participants will:
* Participate in a video call with a specialist to confirm a diagnosis of ASD * Fill out questionnaires online at the start of the study, after 3 months, and after 6 months * Continue with their usual treatment (both groups) and use autimia, a digital health intervention, for six months (intervention group only)
Inclusion: prior suspected diagnosis of ASD by a healthcare professional; diagnosis of ASD (ICD-10 codes: F84.5, F84.0, F84.1) confirmed in a semi-structured diagnostic interview conducted as a telemedical consultation; IQ ≥ 80; increased levels of psychological distress (DASS-21 total score ≥ 21); stable treatment (medication, psychotherapy, no treatment, …) for at least 30 days at the time of inclusion; sufficient knowledge of the German language; basic IT skills required for independent use of a digital intervention; consent to participation.
Exclusion: plans to change treatment (medication, psychotherapy, …) in the upcoming 3 months after inclusion; diagnosis of another severe psychiatric disorder (acute severe affective disorder, acute psychotic disorder, acute substance use disorder, borderline personality disorder, antisocial personality disorder); acute suicidality; currently being under legal guardianship for healthcare decisions.