RecruitingNot ApplicableNCT07638657

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)

Sponsor

Gaia AG

Enrollment

236 participants

Start Date

Jun 12, 2026

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria4

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALautimia

Participants allocated to the intervention group will receive access to autimia in addition to treatment as usual (TAU). autimia is a digital health intervention designed for individuals with ASD (Autism Spectrum Disorder), accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT), health behavior change, and patient education. Topics addressed by autimia are self-acceptance and self-worth, stress management and coping skills, optimizing the environment and communication, as well as understanding emotions and social interactions. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their progress. Once registered, the program remains accessible for six months.