NCT07638657Recruiting
Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder
Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico Trial)
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 12 Jun 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Gaia AG
- Diseases
- Autism
- NCT number
- NCT07638657
What you commit to
- Study type: Interventional
- Planned participants: 236
- From 12 Jun 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- plans to change treatment (medication, psychotherapy, …) in the upcoming 3 months after inclusion
Other illness
- diagnosis of another severe psychiatric disorder (acute severe affective disorder, acute psychotic disorder, acute substance use disorder, borderline personality disorder, antisocial personality disorder)
Other
- acute suicidality
- currently being under legal guardianship for healthcare decisions
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GAIA AG Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.