Effectiveness of the Combination of Water Aerobics and Metacognitive Training

August 21, 2024 updated by: Fundació Sant Joan de Déu

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Barcelona
      • Sant Boi De Llobregat, Barcelona, Spain, 08830
        • Recruiting
        • Parc Sanitari Sant Joan de Déu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Water aerobics
Aerobic exercises performed in a swimming pool.
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.
Active Comparator: Metacognitive Training (MCT)
Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation.
Behavioral: 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.
Experimental: Combined intervention (water aerobics + MCT)
Combination of water aerobics and MCT sessions.
Behavioral: Combined intervention
Patients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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.
Baseline and 3-month follow-up
Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
Time Frame: 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.
Baseline and 3-month follow-up
Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021)
Time Frame: Baseline and 3-month follow-up
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
Time Frame: Baseline and 3-month follow-up
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
Time Frame: 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.
Baseline and 3-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
Depressive symptoms
Baseline and 3-month follow-up
Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline
Premorbid IQ assessed with the Vocabulary subscale
Baseline
Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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)
Time Frame: Baseline and 3-month follow-up
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
Time Frame: Baseline and 3-month follow-up
Beats per minute (bpm)
Baseline and 3-month follow-up
Change from Blood Pressure at 3 months
Time Frame: Baseline and 3-month follow-up
Millimetre of mercury (mmHg)
Baseline and 3-month follow-up
Change from Weight at 3 months
Time Frame: Baseline and 3-month follow-up
Kilogram (Kg)
Baseline and 3-month follow-up
Change from Height at 3 months
Time Frame: Baseline and 3-month follow-up
Centimetre (cm)
Baseline and 3-month follow-up
Change from Body Mass Index (BMI) at 3 months
Time Frame: Baseline and 3-month follow-up
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
Time Frame: Baseline and 3-month follow-up
Centimetre (cm)
Baseline and 3-month follow-up
Change from Glucose Levels at 3 months
Time Frame: Baseline and 3-month follow-up
Milligrams per decilitre (mg/dL)
Baseline and 3-month follow-up
Change from Total Cholesterol at 3 months
Time Frame: Baseline and 3-month follow-up
Milligrams per decilitre (mg/dL)
Baseline and 3-month follow-up
Change from HDL Cholesterol at 3 months
Time Frame: Baseline and 3-month follow-up
Milligrams per decilitre (mg/dL)
Baseline and 3-month follow-up
Change from LDL Cholesterol at 3 months
Time Frame: Baseline and 3-month follow-up
Milligrams per decilitre (mg/dL)
Baseline and 3-month follow-up
Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months
Time Frame: Baseline and 3-month follow-up
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
Time Frame: Baseline and 3-month follow-up
Sleep quality
Baseline and 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Sant Joan de Déu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parc Sanitari Sant Joan de Déu
Solidaritat Sant Joan de Déu
Fluidra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susana Ochoa, PhD, Parc Sanitari Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIC-155-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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