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

Sponsor
Gaia AG
Study ID
NCT07638657
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • autimia — BEHAVIORAL
    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.

Study Details

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)

Key Dates

First listed
Jun 10, 2026
Start date
Jun 12, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
236 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: autimia
    Participants will receive access to the digital health intervention autimia in addition to TAU.
  • No Intervention: Control group
    Participants allocated to the control group will receive access to treatment as usual (TAU).

Primary Outcome Measure

21-item Depression, Anxiety, and Stress Scales (DASS-21) total score [ Time Frame: 3 months ]

Central Contacts

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