Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Cognitive Flexibility Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**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.
排除标准
- •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.
结局指标
主要结局
Change in Cognitive Flexibility Score
时间窗: 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 Executive Functioning Score
时间窗: 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 Theory of Mind Score
时间窗: 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
时间窗: 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).
Change in Global Cognitive Performance Score
时间窗: 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
时间窗: 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 Attributional Style Score
时间窗: 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 Cognitive Flexibility Score
时间窗: 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 Working Memory Score
时间窗: Week 0, Week 12, Week 24
Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance.
次要结局
未报告次要终点
研究者
Susana Ochoa
PhD, Research Unit Coordinator
Fundació Sant Joan de Déu