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

NCT06993831 | Completed

• 1 other identifier: H-24046055
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Negative Symptoms in Schizophrenia; Schizophrenia Spectrum Disorders

Keywords

schizophrenia; psychotherapy; VR; psychosocial intervention; psychosis; negative symptoms

Outcome Measures

Primary Outcomes (3)

• Feasibility and acceptability as assessed by recruitment rate

  Percentage of target sample (30 participants) recruited after 15 months from study start

  Recruitment rate is monitored throughout the study period (15 months)

• Feasibility and acceptibility as assessed by retention rate

  Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (10 sessions)

  Retention rates are monitored throughout the study period (15 months)

• Feasibility and acceptability as assessed by level of satisfaction in the experimental group

  Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a 10-point Likert scale with higher scoring indicating a higher level of satisfaction with therapy.

  At 12 weeks follow-up

Secondary Outcomes (5)

• Severity of negative symptoms as assessed by the Brief Negative Symptoms Scale (BNSS)

  Baseline and at 12 weeks follow-up

• Severity of negative symptoms as assessed by the Scale for the Assessment of Negative Symptoms (SANS)

  Baseline and at 12 weeks follow-up

• Severity of negative symptoms as assessed by the Self-evaluation of Negative Symptoms (SNS)

  Baseline and at 12 weeks follow-up

• Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)

  Baseline and at 12 weeks follow-up

• Social functioning as assessed by the Social Functioning Scale (SFS)

  Baseline and at 12 weeks follow-up

Other Outcomes (20)

• Psychological well-being as assessed by The World Health Organisation- Five Well-Being Index (WHO-5)

  Baseline and at 12 weeks follow-up

• Level of depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia (CDSS)

  Baseline and at 12 weeks follow-up

• Perceived interpersonal pleasure as assessed by the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

  Baseline and at 12 weeks follow-up

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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

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.

Behavioral: Virtual Reality-based psychotherapy

Interventions

Virtual Reality-based psychotherapy BEHAVIORAL

A manualized, modularized, Virtual Reality-based intervention comprising 10 sessions of 1 hour each. The VR therapy aims at enhancing anticipatory pleasure and positive emotions by amplifying exposure and reactivity towards social environments and rewarding activities using a highly elaborate VR software. The VR exposure comprises several different virtual social environments (e.g., a bus, a café, a park etc.) In a tailored treatment approach, therapists will guide participants to train focusing on positive stimuli, engage in activities, experience social rewards, and practice expressing emotions through body language. The therapy focuses on increasing the awareness of positive outcomes that may influence motivation. The therapy deploys activity appraisal/re-appraisal intended to enhance the salience of future opportunities for reward and desire for such rewards, thus targeting reward anticipation processes and promoting enjoyable daily-life activities.

Also known as: ENGAGE

VR-based psychotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Copenhagen Research Center for Mental Health (CORE), Mental Health Services CPH, Denmark

Hellerup, Greater Copenhagen, 2900, Denmark

Location

Related Publications (1)

• Donath VM, Ries ES, Mariegaard L, Kristensen TD, Ebdrup BH, Strauss GP, Fisher PM, Rostrup E, Nordentoft M, Hilker R, Melau M, Bockting CL, Albert N, van Bennekom MJ, Ambrosen KS, Glenthoj LB. Alleviating negative symptoms in schizophrenia using a virtual reality-based therapy targeting social reward learning (ENGAGE): Protocol for a randomised, controlled, assessor-blind pilot study. PLoS One. 2025 Oct 8;20(10):e0331632. doi: 10.1371/journal.pone.0331632. eCollection 2025.

  PMID: 41060907 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Louise B Glenthøj, PhD, dr.med.

  VIRTU Research Group, Mental Health Center Copenhagen, Copenhagen University Hospital - Mental Health Services CPH, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: May 29, 2025
• Study Start: December 9, 2024
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)