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| ID | Type | Description | Link |
|---|---|---|---|
| PS-01-24 | Registry Identifier | ethics comitee Parc Sanitari Sant Joan de Déu |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, Week 12, Week 24 |
| 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. | Week 0, Week 12, Week 24. |
| 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. | Week 0, Week 12, Week 24 |
| 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. | Week 0, Week 12, Week 24 |
| Change in Metacognition Score | Cognitive insight measured by the Beck Cognitive Insight Scale (BCIS): Self-reflectiveness (0-27; higher = better) and Self-certainty (0-21; higher = worse). | Week 0, Week 12, Week 24 |
| Change in Cognitive Flexibility Score | Mental flexibility assessed with the Trail Making Test, Part B. Outcome: time in seconds (maximum 300 seconds); lower times = better performance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Childhood Trauma Exposure (Baseline moderator) | Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure. | Week 0 (one-time measure). |
| Change in Verbal Skills Score |
**Inclusion Criteria:**
**Exclusion Criteria:**
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susana Ochoa, PhD | Contact | +34936406350 | 1253 | susana.ochoa@sjd.es |
| Luciana Díaz-Cutraro, PhD | Contact | +34936406350 | luciana.diaz@sjd.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu | Recruiting | Barcelona | Catalonia | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8541250 | Background | 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. | |
| 12615092 | Background | 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. |
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Anonymized individual participant data (IPD) will be made available upon reasonable request, after publication of primary results, and subject to approval by the research ethics committee and data protection regulations.
Anonymized IPD and supporting documents will be made available after publication of the main study results and for a minimum period of 5 years, starting approximately 12 months after study completion.
Qualified researchers affiliated with academic or healthcare institutions may request access to anonymized IPD and supporting documents for independent verification or secondary analysis. Requests will be reviewed by the sponsor and must include a data-sharing agreement and ethics approval. Access will be provided through a secure institutional platform.
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D006212 | Hallucinations |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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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.
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|
| Week 0, Week 12, Week 24 |
| Change in Global Cognitive Performance Score | Global cognition assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP). Total score range: 0-75; higher = better cognitive performance. | Week 0, Week 12, Week 24 |
| Change in Working Memory Score | Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance. | Week 0, Week 12, Week 24 |
Verbal ability assessed by WAIS-IV Vocabulary. Scaled score range: 1-19; higher scores = better verbal ability.
| Week 0, Week 12, Week 24 |
| 34627191 | Background | 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. |
| 5124116 | Background | 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. |
| 15099613 | Background | 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. |
| 17453895 | Background | 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. |
| 32220501 | Background | 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. |
| 36513402 | Background | 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 Psiquiatr Salud Ment (Engl Ed). 2022 Oct-Dec;15(4):259-271. doi: 10.1016/j.rpsmen.2020.03.002. |
| 37069194 | Background | Stephan-Otto C, Nunez C, Lombardini F, Cambra-Marti MR, Ochoa S, Senior C, Brebion G. Neurocognitive bases of self-monitoring of inner speech in hallucination prone individuals. Sci Rep. 2023 Apr 17;13(1):6251. doi: 10.1038/s41598-023-32042-4. |
| 37716848 | Background | Diaz-Cutraro L, Garcia-Mieres H, Dimaggio G, Lysaker P, Moritz S, Ochoa S. Metacognition in psychosis: What and how do we assess it? Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):206-207. doi: 10.1016/j.rpsm.2022.09.003. Epub 2022 Sep 24. No abstract available. |
| 39468363 | Background | Garety PA, Edwards CJ, Jafari H, Emsley R, Huckvale M, Rus-Calafell M, Fornells-Ambrojo M, Gumley A, Haddock G, Bucci S, McLeod HJ, McDonnell J, Clancy M, Fitzsimmons M, Ball H, Montague A, Xanidis N, Hardy A, Craig TKJ, Ward T. Digital AVATAR therapy for distressing voices in psychosis: the phase 2/3 AVATAR2 trial. Nat Med. 2024 Dec;30(12):3658-3668. doi: 10.1038/s41591-024-03252-8. Epub 2024 Oct 28. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |