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

12 juni 2026 uppdaterad av: Gaia AG

Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico 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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This pragmatic, two-arm randomized controlled trial evaluates the effectiveness of autimia, a certified medical device (CE-marked, risk class I), when used alongside regular treatment. The study compares the addition of this digital health intervention to treatment as usual (TAU) against TAU alone. Designed as an interactive online program, autimia incorporates recognized elements of cognitive behavioral therapy (CBT), behavior change, and patient education.

To ensure the inclusion of the appropriate target population, participants undergo a video-based diagnostic consultation with trained clinical professionals. This session involves a semi-structured interview and a standardized social behavior observation based on the ADOS-2 to confirm the diagnosis according to ICD-10-GM criteria.

Following confirmation, participants are randomly assigned to one of two groups. The intervention group receives immediate access to autimia for six months alongside their usual treatment. The control group continues their regular treatment and is granted access to the intervention after a six-month waiting period.

Data is collected from both groups via online questionnaires at the start of the study, after three months, and after six months. The primary evaluation of effectiveness will be conducted at the three-month follow-up. Data collected at the six-month mark will be utilized to assess the stability of the observed intervention effects.

Studietyp

Interventionell

Inskrivning (Beräknad)

236

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • 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 Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollgrupp
Deltagare som tilldelats kontrollgruppen kommer att få tillgång till behandling som vanligt (TAU).
Experimentell: autimia
Participants will receive access to the digital health intervention autimia in addition to TAU.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
21-item Depression, Anxiety, and Stress Scales (DASS-21) total score
Tidsram: 3 months
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Work and Social Adjustment Scale (WSAS) total score
Tidsram: 3 months
The WSAS is a 5-item PROM to assess functional impairment in work, home life, and social activities. The total score is the sum of all items and ranges from 0 to 40. Higher total scores indicate greater disability and thus a worse outcome, whereas lower scores indicate less disability and a better outcome.
3 months
Social Responsiveness Scale for Adults (SRS-A) total score
Tidsram: 3 months
The SRS-A is a 65-item PROM to assess social symptomatology in adults with ASD. The total score is the sum of all items and ranges from 0 to 195. Higher total scores indicate greater social impairment and thus a worse outcome, whereas lower scores indicate fewer symptoms and a better outcome.
3 months
Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score
Tidsram: 3 months
The MSWS is a PROM to assess self-esteem. The emotional self-esteem subscale consists of 7 items to assess emotional self-worth. The subscale score is the sum of these items and ranges from 7 to 49. Lower scores indicate lower self-esteem and thus a worse outcome, whereas higher scores indicate higher self-esteem and a better outcome.
3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Gaia AG

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 juni 2026

Primärt slutförande (Beräknad)

1 mars 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

4 juni 2026

Först inskickad som uppfyllde QC-kriterierna

4 juni 2026

Första postat (Faktisk)

10 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • autimia RCT 2026

Plan för individuella deltagardata (IPD)

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NEJ

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