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

NCT07638657 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-06-16

No results posted yet for this study

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)

Conditions

Interventions

BEHAVIORAL

autimia

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.

Sponsors & Collaborators

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Isabel Dziobek, Prof. Dr. · Humboldt-Universität zu Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638657 on ClinicalTrials.gov