STEPS: A Virtual Reality-based Intervention for Adults With Autism.

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Virtual Reality-based Social Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06438536

H-23055504

Details and patient eligibility

About

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:

1. Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD?
2. Is Virtual Reality-based social cognitive training cost-effective?

Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness.

Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline.

Full description

Adults with autism spectrum disorders (ASD) constitute an increasingly recognized population with largely unaddressed public health needs. Research on effective interventions for adults with ASD lags far behind that dedicated to children with ASD, as well as other psychiatric disorders.

Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially, to achieve adequate vocational functioning (i.e. job/educational achievements) as well as inflicting immensely on their quality of life. At current, no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD.

Virtual reality-based treatment offers the possibility of creating artificial experiences in real time, that make the user feel immersed and able to interact as if it was the real world. Additionally, virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient.

Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective. While the potential beneficial effects of virtual reality exposure to challenging social situations, that taps social cognitive functions, are evident and virtual reality therapies are promising in general, the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD.

The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) versus treatment as usual. We expect to find VRSCT to be more beneficial in improving social cognitive deficits, daily life functioning, and quality of life in adults with ASD.

If the results of the current trial are positive, this short-term, manualised treatment using well-tested VR-software, can easily be implemented in clinical practice, that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients. Additionally, it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of 18 years or older
2. Ability to give informed consent
3. Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8)
4. T-score on SRS-A self-report ≥ 60

Exclusion criteria

1. Rejecting informed consent
2. A diagnosis of organic brain disease
3. Intellectual disability (IQ ˂ 70)
4. A command of spoken Danish or English inadequate for engaging in therapy
5. ADHD-diagnosis with untreated symptoms
6. Displaying an imminent homicidal or suicidal risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Virtual Reality-based Social Cognitive Training (VRSCT)

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Reality-based Social Cognitive Training

Treatment as Usual (TAU)

No Intervention group

Description:

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.