Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGaia AG

About this 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)

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • autimia

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators