Effectiveness of the Combination of Water Aerobics and Metacognitive Training

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: Water aerobics
* Behavioral: Metacognitive Training (MCT)
* Behavioral: Combined intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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...)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water aerobics<br>Aerobic exercises performed in a swimming pool. | Behavioral: Water aerobics<br>* 1-hour session of water aerobics per week, for 3 months. A specialized trainer will carry out water aerobics sessions and will focus on motor coordination, strength and cardiovascular workout.<br>|
| Active Comparator: Metacognitive Training (MCT)<br>Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation. | Behavioral: Metacognitive Training (MCT)<br>* 1-hour session of MCT per week, for 3 months. A trained psychologist will carry out the MCT sessions. MCT addresses the most common cognitive biases in psychosis. Each session will focus on one topic, such as attributional style, jumping to conclusions, theory of mind, emotion recognition, memory or empathy.<br>|
| Experimental: Combined intervention (water aerobics + MCT)<br>Combination of water aerobics and MCT sessions. | Behavioral: Combined intervention<br>* Patients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012) | 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. | Baseline and 3-month follow-up | 
| Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987) | 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. | Baseline and 3-month follow-up | 
| Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021) | Measure of five cognitive biases (30 items): jumping to conclusions, intentionalising, catastrophising, emotional reasoning, and dichotomous thinking. | Baseline and 3-month follow-up | 
| Change from Baseline Stress Test at 3 months | Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry. | Baseline and 3-month follow-up | 
| Change from Baseline Molecular measures at 3 months | 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. | Baseline and 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995) | Semi-structured interview to assess positive, negative and general symptoms of psychosis. Higher scores indicate greater severity of symptoms. | Baseline and 3-month follow-up | 
| Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996) | Depressive symptoms | Baseline and 3-month follow-up | 
| Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007) | Self-esteem measure with 10 items (scores 0 to 30). Higher scores indicate greater self-esteem. Scores below 15 may indicate problematic low self-esteem. | 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) | Attributional Style, including externalizing and personalizing bias subscales. | Baseline and 3-month follow-up | 
| Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995) | Theory of mind | Baseline and 3-month follow-up | 
| Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021) | Facial emotion recognition | 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) | Verbal processing speed, verbal fluency, attention, working memory, verbal learning and memory, visual learning and memory, reasoning, problem solving. | Baseline and 3-month follow-up | 
| WAIS-IV (Weschler Adults Intelligence Scale, 1955) | Premorbid IQ assessed with the Vocabulary subscale | Baseline | 
| Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976) | General functioning in a scale of 0-100 | 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) | Self-administered 12-item disability assessment | Baseline and 3-month follow-up | 
| Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015) | Self-administered 14-item scale to assess self-stigma | Baseline and 3-month follow-up | 
| Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999) | Self-administered 5-item to assess general quality of life | 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) | 3 items to assess awareness of having a mental illness, awareness of medication effects and awareness of social consequences of having a mental illness, in a scale of 0-15. Higher scores mean a worse outcome. | Baseline and 3-month follow-up | 
| Change from Heart Rate at 3 months | Beats per minute (bpm) | Baseline and 3-month follow-up | 
| Change from Blood Pressure at 3 months | Millimetre of mercury (mmHg) | Baseline and 3-month follow-up | 
| Change from Weight at 3 months | Kilogram (Kg) | Baseline and 3-month follow-up | 
| Change from Height at 3 months | Centimetre (cm) | Baseline and 3-month follow-up | 
| Change from Body Mass Index (BMI) at 3 months | Weight and height will be combined to report BMI in kg/m^2 | Baseline and 3-month follow-up | 
| Change from Body Abdominal Girth at 3 months | Centimetre (cm) | Baseline and 3-month follow-up | 
| Change from Glucose Levels at 3 months | Milligrams per decilitre (mg/dL) | Baseline and 3-month follow-up | 
| Change from Total Cholesterol at 3 months | Milligrams per decilitre (mg/dL) | Baseline and 3-month follow-up | 
| Change from HDL Cholesterol at 3 months | Milligrams per decilitre (mg/dL) | Baseline and 3-month follow-up | 
| Change from LDL Cholesterol at 3 months | Milligrams per decilitre (mg/dL) | Baseline and 3-month follow-up | 
| Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months | Intensity of physical activity and sitting time | Baseline and 3-month follow-up | 
| Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months | Sleep quality | Baseline and 3-month follow-up |