Efficacy of the Combination of Water Aerobics and Metacognitive Training (MCT) on Psychological and Physical Health Variables and Their Relationship With SP1 and SP4 Biomarkers in People With Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
研究概览
简要总结
The objective of this study is to assess the efficacy of a combined intervention of water aerobics and Metacognitive Training (MCT), compared to each intervention separately, in people with psychosis. One purpose is to analyze the improvement of clinical, cognitive, metacognitive and psychosocial variables, motor coordination and physical health condition. Another purpose is to study the changes in SP1 and SP4 biomarker transcription levels as a function of the intervention received. The hypothesis is that the combined intervention will enhance the benefits of each intervention separately, specifically in symptoms, cognition, metacognition and psychosocial variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blind to the intervention recieved by the participants
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of one of the following diagnoses according to DSM-V criteria: schizophrenia, unspecific psychotic disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder.
- •Psychopatological stability
- •18 to 55 years old
- •Interested in participating in both water aerobics and MCT groups
排除标准
- •Head injury or intellectual disabillity (premorbid IQ <=70)
- •Present scores on the PANSS >=5 in hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group
- •Patients with substance dependence disorder
- •Problems related to water activities (phobia, severe mobility problems...)
结局指标
主要结局
Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
时间窗: Baseline and 3-month follow-up
Measure of jumping to conclusions bias. It includes two tasks in which two jars with colored beads are presented. The first task has a 85:15 proportion and the second task has a 60:40 proportion. In the third task, the jars contain positive and negative comments, with a proportion of 60:40 in each jar. The person has to infer from which jar the beads or comments are drawn. Jumping to conclusions bias is present when the participant decides after seeing up to two beads or comments.
Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021)
时间窗: Baseline and 3-month follow-up
Measure of five cognitive biases (30 items): jumping to conclusions, intentionalising, catastrophising, emotional reasoning, and dichotomous thinking.
Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
时间窗: Baseline and 3-month follow-up
Cognitive insight self-registered measure (15 items): ability to analyze one's own beliefs and judgments. Self-reflectivness subscale: higher scores indicate a greater ability to reflect on one's own thoughts. Selfcertainty subscale: higher scores indicate a greater tendency to overestimate one's own beliefs without considering alternative explanations. Composite index: higher scores indicate a greater cognitive insight.
Change from Baseline Stress Test at 3 months
时间窗: Baseline and 3-month follow-up
Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry.
Change from Baseline Molecular measures at 3 months
时间窗: Baseline and 3-month follow-up
Protein levels of SP1 and SP4 biomarkers transcription factor levels in peripheral blood mononuclear cells (PBMCs). mRNA expression levels of SP1 and SP4 biomarkers transcription factors in PBMCs.
次要结局
- Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)(Baseline and 3-month follow-up)
- Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months(Baseline and 3-month follow-up)
- Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months(Baseline and 3-month follow-up)
- WAIS-IV (Weschler Adults Intelligence Scale, 1955)(Baseline)
- Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995)(Baseline and 3-month follow-up)
- Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)(Baseline and 3-month follow-up)
- Change from Baseline IPSAQ Internal, Personal and Situational Attributions Questionnaire at 3 months (McArthur, 1972; Bentall et al, 1991; Diez-Alegría, 2006)(Baseline and 3-month follow-up)
- Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)(Baseline and 3-month follow-up)
- Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021)(Baseline and 3-month follow-up)
- Change from Baseline MATRICS Consensus Cognitive Battery at 3 months (Nuechterlein et al., 2008; Rodriguez-Jimenez et al., 2012)(Baseline and 3-month follow-up)
- Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)(Baseline and 3-month follow-up)
- Change from Baseline WHO-DAS 12, Psychiatric Disability Assessment Schedule at 3 months (WHO, 1988; Vázquez-Barquero JL, 2000)(Baseline and 3-month follow-up)
- Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015)(Baseline and 3-month follow-up)
- Change from Heart Rate at 3 months(Baseline and 3-month follow-up)
- Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999)(Baseline and 3-month follow-up)
- Change from Baseline SUMD Scale to Assess Unawareness of Mental Disorder at 3 months (Amador X.F., et al.; 1993; Ruiz A., et al., 2008)(Baseline and 3-month follow-up)
- Change from Blood Pressure at 3 months(Baseline and 3-month follow-up)
- Change from Weight at 3 months(Baseline and 3-month follow-up)
- Change from Height at 3 months(Baseline and 3-month follow-up)
- Change from Body Mass Index (BMI) at 3 months(Baseline and 3-month follow-up)
- Change from Glucose Levels at 3 months(Baseline and 3-month follow-up)
- Change from Total Cholesterol at 3 months(Baseline and 3-month follow-up)
- Change from HDL Cholesterol at 3 months(Baseline and 3-month follow-up)
- Change from LDL Cholesterol at 3 months(Baseline and 3-month follow-up)
- Change from Body Abdominal Girth at 3 months(Baseline and 3-month follow-up)