Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis

Official title

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

Overview

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.

Detailed description

This interventional study investigates the impact of cognitive, metacognitive, and social cognition variables on the outcomes of VR-based Avatar Therapy for auditory hallucinations in patients with psychosis. Participants will be assessed at four key time points: screening (week 0), baseline (week 12), during the intervention (weeks 12-24), and post-therapy (week 24).

The intervention consists of 7 individual VR-based Avatar Therapy sessions delivered over 12 weeks. The therapy uses virtual reality to externalize and reframe distressing auditory hallucinations, helping participants develop more adaptive responses.

In addition to evaluating the therapy's effectiveness, the study incorporates validated tools to measure:

Social Cognition: Emotional recognition (Test de Reconocimiento Emocional), attributional style (AIHQ), theory of mind (Hinting Task), and social perception (SFRT-2).

Metacognition: Insight and cognitive monitoring using the BCIS and CBQ. Cognition: Neuropsychological functions, including attention, flexibility, and memory (SCIP, Stroop, TMT, and Vocabulary WAIS).

Trauma as a predisposing factor: Using the Childhood Trauma Questionnaire (CTQ).

By examining these variables, the study aims to deepen the understanding of their influence on treatment outcomes and inform the development of personalized therapeutic approaches for psychosis.

Interventions

• Behavioral VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments
  VR-Based Avatar Therapy is a 12-week intervention designed to help patients with psychosis manage distressing auditory hallucinations. The therapy consists of 7 individual sessions using virtual reality (VR) technology to externalize the auditory hallucinations, allowing patients to interact with a computer-generated avatar representing their dominant voice. In addition to standard therapy, participants will undergo assessments of cognition, metacognition, and social cognition to explore their

Primary outcome measures

• Change in Emotion Recognition Score [Time frame: Week 0, Week 12, Week 24]
• Change in Executive Functioning Score [Time frame: Week 0, Week 12, Week 24.]
• Change in Attributional Style Score [Time frame: Week 0, Week 12, Week 24]
• Change in Theory of Mind Score [Time frame: Week 0, Week 12, Week 24]
• Change in Metacognition Score [Time frame: Week 0, Week 12, Week 24]
• Change in Cognitive Flexibility Score [Time frame: Week 0, Week 12, Week 24]
• Change in Global Cognitive Performance Score [Time frame: Week 0, Week 12, Week 24]
• Change in Working Memory Score [Time frame: Week 0, Week 12, Week 24]

Eligibility criteria

\*\*Inclusion Criteria:\*\*

• 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.

\*\*Exclusion Criteria:\*\*

• Inability to identify a dominant voice for Avatar Therapy intervention.
• Intellectual disability based on medical history.
• Active substance abuse.
• Central nervous system injury or neurological disorders affecting cognitive performance.
• Severe visual impairment that precludes the use of VR technology.
• Aversion to virtual reality or prior experience of simulator sickness.
• Current suicidal ideation or risk.
• Lack of cooperation or inability to comply with study procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu — Barcelona

Publications

• Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g. PMID 8541250
• Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0. PMID 12615092
• Schmid P, Czekaj A, Frick J, Steinert T, Purdon SE, Uhlmann C. The screen for cognitive impairment in psychiatry (SCIP) as a routinely applied screening tool: pathology of acute psychiatric inpatients and cluster analysis. BMC Psychiatry. 2021 Oct 9;21(1):494. doi: 10.1186/s12888-021-03508-4. PMID 34627191
• Reitan RM. Trail making test results for normal and brain-damaged children. Percept Mot Skills. 1971 Oct;33(2):575-81. doi: 10.2466/pms.1971.33.2.575. No abstract available. PMID 5124116
• Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0. PMID 15099613
• Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854. PMID 17453895
• Brebion G, Stephan-Otto C, Cuevas-Esteban J, Usall J, Ochoa S. Impaired memory for temporal context in schizophrenia patients with hallucinations and thought disorganisation. Schizophr Res. 2020 Jun;220:225-231. doi: 10.1016/j.schres.2020.03.014. Epub 2020 Mar 24. PMID 32220501
• Lorente-Rovira E, Grasa E, Ochoa S, Corripio I, Pelaez T, Lopez-Carrilero R, Gutierrez-Gea A, Morano-Guillen M, Villagran JM, Bartels-Velthuis AA, Jenner JA, Sanjuan J. Different measures for auditory hallucinations in populations with psychosis. The Validation of the Spanish versions of the Auditory Vocal Hallucination Rating Scale (AVHRS) and the Positive and Useful Voices Inquiry (PUVI). Rev Ps PMID 36513402

Identifiers

NCT: NCT07091344 · PS-01-24 · PS-01-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗