NCT Number: NCT07091344
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, Catalonia, 08950, Spain
Location status: Recruiting
Luciana Diaz-Cutraro, PhD
SUB_INVESTIGATOR
Luciana Díaz-Cutraro, PhD
CONTACT
Marina Peniza-Soriano, Master degree
SUB_INVESTIGATOR
Susana Ochoa, PhD
CONTACT
Susana Ochoa, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
**Inclusion Criteria:**
**Exclusion Criteria:**
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 0, Week 12, Week 24
Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance.
Time frame: Week 0 (one-time measure).
Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure.
Time frame: Week 0, Week 12, Week 24
Verbal ability assessed by WAIS-IV Vocabulary. Scaled score range: 1-19; higher scores = better verbal ability.
Contact information is provided by the study sponsor or research team.
Fundació Sant Joan de Déu
Other
Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy
Acronym: Meta-VR-AVATAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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