Effectiveness of the Combination of Water Aerobics and Metacognitive Training

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455593
• Other study ID #: PIC-155-21
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: September 2023

Study information

• Verified date: July 2022
• Source: Fundació Sant Joan de Déu
• Contact: Susana Ochoa, PhD
• Phone: 936406350
• Email: susana.ochoa[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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...)

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Water aerobics
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.
• Metacognitive Training (MCT)
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.
• Combined intervention
Patients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.

Locations

Country	Name	City	State
Spain	Parc Sanitari Sant Joan de Déu	Sant Boi De Llobregat	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Fluidra, Parc Sanitari Sant Joan de Déu, Solidaritat Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)	Depressive symptoms	Baseline and 3-month follow-up
Secondary	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
Secondary	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
Secondary	Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)	Theory of mind	Baseline and 3-month follow-up
Secondary	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
Secondary	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
Secondary	WAIS-IV (Weschler Adults Intelligence Scale, 1955)	Premorbid IQ assessed with the Vocabulary subscale	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Heart Rate at 3 months	Beats per minute (bpm)	Baseline and 3-month follow-up
Secondary	Change from Blood Pressure at 3 months	Millimetre of mercury (mmHg)	Baseline and 3-month follow-up
Secondary	Change from Weight at 3 months	Kilogram (Kg)	Baseline and 3-month follow-up
Secondary	Change from Height at 3 months	Centimetre (cm)	Baseline and 3-month follow-up
Secondary	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
Secondary	Change from Body Abdominal Girth at 3 months	Centimetre (cm)	Baseline and 3-month follow-up
Secondary	Change from Glucose Levels at 3 months	Milligrams per decilitre (mg/dL)	Baseline and 3-month follow-up
Secondary	Change from Total Cholesterol at 3 months	Milligrams per decilitre (mg/dL)	Baseline and 3-month follow-up
Secondary	Change from HDL Cholesterol at 3 months	Milligrams per decilitre (mg/dL)	Baseline and 3-month follow-up
Secondary	Change from LDL Cholesterol at 3 months	Milligrams per decilitre (mg/dL)	Baseline and 3-month follow-up
Secondary	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
Secondary	Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months	Sleep quality	Baseline and 3-month follow-up