Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder
alnico
1 other identifier
interventional
236
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 1, 2027
June 12, 2026
June 1, 2026
8 months
June 4, 2026
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
21-item Depression, Anxiety, and Stress Scales (DASS-21) total score
The DASS-21 is a 21-item PROM to assess psychological distress. The total score is the sum of all items and ranges from 0 to 63. Higher total scores indicate greater psychological distress and thus a worse outcome, whereas lower scores indicate fewer symptoms and a better outcome.
3 months
Secondary Outcomes (3)
Work and Social Adjustment Scale (WSAS) total score
3 months
Social Responsiveness Scale for Adults (SRS-A) total score
3 months
Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score
3 months
Study Arms (2)
autimia
EXPERIMENTALParticipants will receive access to the digital health intervention autimia in addition to TAU.
Control group
NO INTERVENTIONParticipants allocated to the control group will receive access to treatment as usual (TAU).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- sufficient knowledge of the German language
- basic IT skills required for independent use of a digital intervention
- consent to participation
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Gaia AGlead
Study Sites (1)
GAIA AG
Hamburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabel Dziobek, Prof. Dr.
Humboldt-Universität zu Berlin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2026
First Posted
June 10, 2026
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share