ENGAGE: Virtual Reality-based Psychotherapy for Negative Symptoms in Schizophrenia

Mental Health Services in the Capital Region, Denmark

Status: Completed

Conditions: Negative Symptoms in Schizophrenia; Schizophrenia Spectrum Disorders

Treatments: Behavioral: Virtual Reality-based psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06993831

H-24046055 (Other Identifier)

Details and patient eligibility

About

The primary goal of this pilot study is to examine the feasibility and acceptability of a new Virtual Reality-based intervention against negative symptoms in schizophrenia spectrum disorders (SSD).

The main questions it aims to answer are:

1. Is Virtual Reality-based therapy a feasible and acceptable treatment for negative symptoms in SSD?
2. Are there indications that the treatment is effective in reducing negative symptoms, improving daily functioning, and enhancing quality of life?

Researchers will compare the new Virtual Reality-based treatment to standard psychiatric care to evaluate therapy effectiveness.

Participants will be allocated to receive either 10 sessions of Virtual Reality-based therapy or Treatment as usual. All participants will undergo a thorough assessment at baseline and at follow-up after 12 weeks.

Full description

Negative symptoms (NS) are core features of schizophrenia and strongly correlated with vocational and social outcomes, quality of life, and have a higher impact on later outcome than positive symptoms (PS) such as hallucinations and delusions. While there are good medical treatment options for PS, no robust and replicated evidence exists for effective NS treatments. Consistent evidence suggests that abnormalities of the brain reward system are central in the pathogenesis of NS, i.e., the domains of anhedonia and avolition. Preliminary evidence indicates changes in reward learning following therapy is related to a reduction in NS.

Virtual reality (VR) is a promising technologically advanced mental health research tool with high ecological validity. VR allows individuals to immerse themselves in realistic environments and interact with virtual objects, providing a safe and controlled space to address symptoms and improve functioning. Initial evidence (N=4) supports that VR-based interventions significantly reduce NS and improve psychosocial functioning with a medium to large effect size. Given the suggested central role of reward processing disturbances in the pathogenesis of NS, there is an obvious need to investigate the effect of a VR-based intervention targeting reward processing in ameliorating NS.

Both NS and motivational abnormalities reflect complex processes at a system level likely corresponding to functional brain activity within and between several regions and circuits. Supplementing the clinical assessments in the study with magnetic resonance imaging (MRI) data may clarify whether the intervention directly targeting reward processing has an effect on the biological processes/networks involved.

In sum, this study will explore the prospects of using an innovative, VR-based treatment to treat NS and reward processing deficits in schizophrenia aimed at producing real-life benefits for the patients. If found successful, this pilot study could lay the foundation for a larger randomized clinical trial examining the intervention's effectiveness. Prospectively, these results can pave the way for a much sought-after treatment option for NS.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICD-10 diagnosis of a schizophrenia-spectrum disorder (F2x)
• Negative symptom score of ≥3 on the SANS items avolition or anhedonia

Exclusion criteria

• Diagnosis of organic brain disease
• Intellectual disability (IQ < 70)
• Current diagnosis of drug dependency
• Command of spoken Danish or English inadequate for engaging in therapy
• Refusing to be informed on incidental findings on the MRI scans

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Treatment as Usual

No Intervention group

Description:

Participants randomized to this arm will not receive any treatment beyond the standard care offered by the usual health care providers.

VR-based psychotherapy

Experimental group

Description:

Participants randomized to this arm will receive 10 sessions of the VR-based intervention targeting negative symptoms in schizophrenia in addition to any possible treatment offered by other health care providers.

Treatment:

Behavioral: Virtual Reality-based psychotherapy