Virtual Reality therapy for negative symptoms in schizophrenia
ENGAGE Pilot Study: Alleviating Negative Symptoms in Schizophrenia Using a Virtual Reality-based Intervention Targeting Social Reward Learning
This study is testing whether a new Virtual Reality therapy can help people with schizophrenia feel better and improve their daily lives compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mental Health Services in the Capital Region, Denmark Academic / other |
| Locations | 1 site (Hellerup, Greater Copenhagen) |
| Trial ID | NCT06993831 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility and acceptability of a Virtual Reality-based intervention designed to address negative symptoms in schizophrenia spectrum disorders. Participants will be randomly assigned to receive either 10 sessions of this innovative therapy or standard psychiatric care. The study will evaluate the effectiveness of the VR therapy in reducing negative symptoms, improving daily functioning, and enhancing quality of life through assessments conducted at baseline and after 12 weeks. The research seeks to explore the potential of VR as a tool for improving psychosocial outcomes in individuals with schizophrenia.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with a schizophrenia-spectrum disorder who exhibit significant negative symptoms, specifically avolition or anhedonia.
Not a fit: Patients with organic brain diseases, intellectual disabilities, or current drug dependency may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel and effective treatment option for patients suffering from negative symptoms of schizophrenia.
How similar studies have performed: Preliminary evidence from small-scale studies suggests that VR-based interventions may effectively reduce negative symptoms, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hellerup, Greater Copenhagen
- Copenhagen Research Center for Mental Health (CORE), Mental Health Services CPH, Denmark — Hellerup, Greater Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Louise B Glenthøj, PhD, dr.med. — VIRTU Research Group, Mental Health Center Copenhagen, Copenhagen University Hospital - Mental Health Services CPH, Denmark
- Study coordinator: Valentin M Donath, MSc
- Email: valentin.donath@regionh.dk
- Phone: +4520366374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.