Sponsor study identifier
interventional
140
1 country
1
Study Start
May 2, 2024
Actual (reported)Primary Completion
July 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2024
Actual (reported)May 23, 2024
Actual (reported)June 3, 2024
Actual (reported)July 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Social Responsiveness Scale, Adult Version, Self-report
The primary outcome is level of social impairment is measured by the Social Responsiveness Scale, Second Edition, Adult version, Self-report (SRS-2A) at cessation of treatment at 3-months. SRS-2A measures the presence and severity of social impairment in everyday life. The SRS-2A is a commonly used measure in autism spectrum research and has demonstrated good reliability and validity. SRS-2A is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life. Follow-up assessments will comprise ratings of the previous two-week period.
Baseline, 3 month follow-up and 6 month follow-up
Social Responsiveness Scale, Adult Version, Informant Report
Baseline, 3 month follow-up and 6 month follow-up
Social Interaction Anxiety Scale (SIAS)
Baseline, 3 month follow-up and 6 month follow-up
The Empathy Quotient
Baseline, 3 month follow-up and 6 month follow-up
The High Risk Social Challenge Task (HiSoC)
Baseline, 3 month follow-up and 6 month follow-up
Emotion Recognition Task (CANTAB ERT)
Baseline, 3 month follow-up and 6 month follow-up
CAT-Q (Camouflaging Autistic Traits Questionnaire)
Baseline, 3 month follow-up and 6 month follow-up
SR-AS (Questionnaire on sensory reactions)
Baseline, 3 month follow-up and 6 month follow-up
Beck Depression Inventory (BDI)
Baseline, 3 month follow-up and 6 month follow-up
Patients in the experimental group will be offered 10 individual sessions of targeted, virtual reality assisted psychotherapy embedded in cognitive behavioral therapy (CBT), that aims at enhancing social cognition and daily life functioning. If the patient consents, two additional sessions will be offered in which the patient's relatives are invited to participate (one in the beginning of treatment and one at the end of treatment). The aim of the relative involvement is to enhance transfer from the therapy to the patients daily life. The treatment will be conducted by psychologists with an extensive knowledge in providing virtual reality assisted therapy. The treatment is manualized, and the therapists will receive ongoing supervision by a senior clinician having ≥ 25 years of experience in conducting assessment, treatment, and research with the autism spectrum population.
The treatment-as-usual (TAU) group will receive the standard treatment offered to adults diagnosed with ASD in Denmark. This commonly consists of four psychoeducational sessions as well as limited supportive counseling. Some adults with ASD also receive practical help in daily life situations in community settings. The TAU will be mapped upon trial completion.
Virtual reality assisted social cognitive training embedded in cognitive behavioral therapy, that aims at enhancing social cognition and daily life functioning.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark
Copenhagen, Hellerup, 2900, Denmark
Andresen J, Jeppesen ACE, Due AS, Mariegaard LS, Parvaiz R, Hjorthoj C, Pinkham AE, Nordentoft M, Letnar G, Jepsen JRM, Glenthoj LB. The Effect of Virtual Reality-Based Social Cognitive Training for Autistic Adults: Protocol for STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) Randomized Clinical Trial. JMIR Res Protoc. 2026 Jan 5;15:e72854. doi: 10.2196/72854.
Louise B. Glenthøj, DrMSc
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen
First Submitted
May 23, 2024
First Posted
June 3, 2024
Contact the study team to confirm eligibility.
Study Start
May 2, 2024
Actual (reported)Primary Completion
July 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 25, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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