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
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.