Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Sant Joan de Déu
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments
BehavioralVR-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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VR-Based Avatar Therapy with Cognitive and Metacognitive AssessmentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Emotion Recognition Score
Change in participants' ability to recognize basic emotions using the Faces Test. Score range: 0-20; higher scores = better emotion recognition.
Time frame
Week 0, Week 12, Week 242
Change in Executive Functioning Score
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.
Time frame
Week 0, Week 12, Week 24.3
Change in Attributional Style Score
Attributional style in ambiguous social situations assessed with the Ambiguous Intentions Hostility Questionnaire (AIHQ). Score range: 0-100; higher scores = greater hostile attribution/conviction.
Time frame
Week 0, Week 12, Week 244
Change in Theory of Mind Score
Ability to infer others' intentions measured by the Hinting Task. Score range: 0-6; higher scores = better Theory of Mind.
Time frame
Week 0, Week 12, Week 24Other outcomes
1
Childhood Trauma Exposure (Baseline moderator)
Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure.
Time frame
Week 0 (one-time measure).2
Change in Verbal Skills Score
Verbal ability assessed by WAIS-IV Vocabulary. Scaled score range: 1-19; higher scores = better verbal ability.
Time frame
Week 0, Week 12, Week 24Sponsors and contacts
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Source ClinicalTrials.gov