NCT07638657 Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder
| NCT ID | NCT07638657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gaia AG |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2026-06-12 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Isabel Dziobek, Prof. Dr.
PRINCIPAL INVESTIGATOR
Humboldt-Universität zu Berlin
Frequently Asked Questions
Who can join the NCT07638657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07638657 currently recruiting?
Yes, NCT07638657 is actively recruiting participants. Contact the research team at linda.betz@gaia-group.com for enrollment information.
Where is the NCT07638657 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT07638657 clinical trial?
NCT07638657 is sponsored by Gaia AG. The principal investigator is Isabel Dziobek, Prof. Dr. at Humboldt-Universität zu Berlin. The trial plans to enroll 236 participants.