Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate the relationship between cognitive, metacognitive and social cognition variables in patients with psychosis undergoing VR-based Avatar Therapy for the treatment of auditory hallucinations. In addition to the primary intervention, participants will be assessed using validated tools for emotion recognition, attributional style, theory of mind, neurocognition, and metacognition. The study also explores the potential role of trauma as a predisposing factor. Assessments will be conducted at four time points: screening (week 0), baseline (week 12), intervention period (weeks 12-24), and post-therapy follow-up (week 24). By investigating these variables, this study seeks to better understand their impact on treatment outcomes and contribute to the development of personalized therapeutic approaches.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years or older.

• Diagnosis of schizophrenia spectrum disorder according to DSM-5 criteria.

• Experience of persistent auditory hallucinations for at least 3 months (PANSS hallucination score ≥ 3).

• Stable medication dosage for at least 4 weeks prior to recruitment.

• Fluent in the spoken language of the study site (Spanish).

• Able to provide informed consent.

• Regular psychiatric follow-up care.

Locations
Other Locations
Spain
Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu
RECRUITING
Barcelona
Contact Information
Primary
Susana Ochoa, PhD
susana.ochoa@sjd.es
+34936406350
Backup
Luciana Díaz-Cutraro, PhD
luciana.diaz@sjd.es
+34936406350
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 30
Treatments
Experimental: VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments
Participants will receive VR-based Avatar Therapy over a 12-week intervention period, consisting of 7 individual therapy sessions. This intervention is designed to externalize and reframe distressing auditory hallucinations using virtual reality.~In addition to the standard therapy, participants will undergo comprehensive assessments of cognition, metacognition, and social cognition at screening (week 0), baseline (week 12), during the intervention (weeks 12-24), and post-therapy (week 24). These measures will evaluate emotional recognition, attributional style, theory of mind, cognitive flexibility, and trauma history, aiming to explore their role in treatment outcomes.
Related Therapeutic Areas
Sponsors
Leads: Fundació Sant Joan de Déu

This content was sourced from clinicaltrials.gov