Schizophrenia Disorders, Treatment Resistant Hallucinations
Conditions
Keywords
VR-based Avatar Therapy, cognition, metacognition, social cognition, psychosis, schizophrenia spectrum disorders, auditory hallucinations, trauma and psychosis, emotion recognition, Personalized therapy
Brief 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.
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
BEHAVIORALVR-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 impact on treatment outcomes. These assessments include measures of emotion recognition, attributional style, theory of mind, cognitive flexibility, and trauma history. Sessions are conducted using VR headsets and noise-canceling headphones to enhance immersion, and patients receive ongoing therapeutic guidance throughout the process.
Sponsors
Fundació Sant Joan de Déu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study employs a single-group pre-post interventional design with a waiting list control phase. All participants will initially undergo a 12-week waiting period (control phase) starting at screening (week 0). Baseline assessments will be conducted at week 12, followed by a 12-week intervention phase where participants receive 7 individual VR-based Avatar Therapy sessions. Post-therapy assessments will be conducted at week 24 to evaluate changes in auditory hallucinations and associated cognitive, metacognitive, and social cognition variables. This design allows for a comprehensive evaluation of both the direct effects of the intervention and the potential moderating or mediating role of the measured variables on therapeutic outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Working Memory Score | Week 0, Week 12, Week 24 | Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance. |
| Change in Cognitive Flexibility Score | Week 0, Week 12, Week 24 | Mental flexibility assessed with the Trail Making Test, Part B. Outcome: time in seconds (maximum 300 seconds); lower times = better performance. |
| Change in Global Cognitive Performance Score | Week 0, Week 12, Week 24 | Global cognition assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP). Total score range: 0-75; higher = better cognitive performance. |
| Change in Emotion Recognition Score | Week 0, Week 12, Week 24 | Change in participants' ability to recognize basic emotions using the Faces Test. Score range: 0-20; higher scores = better emotion recognition. |
| Change in Executive Functioning Score | Week 0, Week 12, Week 24. | Change in Executive Functioning Score Executive functioning assessed with the Wisconsin Card Sorting Test (WCST). Outcomes include number of categories completed (0-6; higher = better) and number of perseverative errors (no fixed maximum; lower = better). The task ends when the participant completes 6 categories or after all 128 cards are placed. |
| Change in Attributional Style Score | Week 0, Week 12, Week 24 | Attributional style in ambiguous social situations assessed with the Ambiguous Intentions Hostility Questionnaire (AIHQ). Score range: 0-100; higher scores = greater hostile attribution/conviction. |
| Change in Theory of Mind Score | Week 0, Week 12, Week 24 | Ability to infer others' intentions measured by the Hinting Task. Score range: 0-6; higher scores = better Theory of Mind. |
| Change in Metacognition Score | Week 0, Week 12, Week 24 | Cognitive insight measured by the Beck Cognitive Insight Scale (BCIS): Self-reflectiveness (0-27; higher = better) and Self-certainty (0-21; higher = worse). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Verbal Skills Score | Week 0, Week 12, Week 24 | Verbal ability assessed by WAIS-IV Vocabulary. Scaled score range: 1-19; higher scores = better verbal ability. |
| Childhood Trauma Exposure (Baseline moderator) | Week 0 (one-time measure). | Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure. |
Countries
Spain
Contacts
Primary ContactSusana Ochoa, PhD
Backup ContactLuciana Díaz-Cutraro, PhD
Outcome results
None listed