Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder
ConditionAutism 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
autimia
BehavioralParticipants 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.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: autimiaExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
Work and Social Adjustment Scale (WSAS) total score
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.
Time frame
3 months2
Social Responsiveness Scale for Adults (SRS-A) total score
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.
Time frame
3 months3
Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score
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.
Time frame
3 months Source ClinicalTrials.gov