Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05455593

Effectiveness of the Combination of Water Aerobics and Metacognitive Training

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location status: Recruiting

Location contact

Susana Ochoa, PhD

CONTACT

[email protected]

936406350 ext. 12538

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Water aerobics

Behavioral

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)

Behavioral

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

Behavioral

Patients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)

    Time frame: Baseline and 3-month follow-up

    Theory of mind

  6. 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

  7. 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.

  8. WAIS-IV (Weschler Adults Intelligence Scale, 1955)

    Time frame: Baseline

    Premorbid IQ assessed with the Vocabulary subscale

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. Change from Heart Rate at 3 months

    Time frame: Baseline and 3-month follow-up

    Beats per minute (bpm)

  15. Change from Blood Pressure at 3 months

    Time frame: Baseline and 3-month follow-up

    Millimetre of mercury (mmHg)

  16. Change from Weight at 3 months

    Time frame: Baseline and 3-month follow-up

    Kilogram (Kg)

  17. Change from Height at 3 months

    Time frame: Baseline and 3-month follow-up

    Centimetre (cm)

  18. 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

  19. Change from Body Abdominal Girth at 3 months

    Time frame: Baseline and 3-month follow-up

    Centimetre (cm)

  20. Change from Glucose Levels at 3 months

    Time frame: Baseline and 3-month follow-up

    Milligrams per decilitre (mg/dL)

  21. Change from Total Cholesterol at 3 months

    Time frame: Baseline and 3-month follow-up

    Milligrams per decilitre (mg/dL)

  22. Change from HDL Cholesterol at 3 months

    Time frame: Baseline and 3-month follow-up

    Milligrams per decilitre (mg/dL)

  23. Change from LDL Cholesterol at 3 months

    Time frame: Baseline and 3-month follow-up

    Milligrams per decilitre (mg/dL)

  24. 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

  25. Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months

    Time frame: Baseline and 3-month follow-up

    Sleep quality

Study contacts

Contact information is provided by the study sponsor or research team.

Susana Ochoa, PhD

CONTACT

[email protected]

936406350 ext. 12538

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Fluidra
  • Parc Sanitari Sant Joan de Déu
  • Solidaritat Sant Joan de Déu

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2022
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.