Effectiveness of the Combination of Water Aerobics and Metacognitive Training

NCT05455593 | Recruiting

• 1 other identifier: PIC-155-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (25)

• 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 Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)

  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

Study Arms (3)

Water aerobics

ACTIVE COMPARATOR

Aerobic exercises performed in a swimming pool.

Behavioral: Water aerobics

Metacognitive Training (MCT)

ACTIVE COMPARATOR

Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation.

Behavioral: Metacognitive Training (MCT)

Combined intervention (water aerobics + MCT)

EXPERIMENTAL

Combination of water aerobics and MCT sessions.

Behavioral: Combined intervention

Interventions

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.

Water aerobics

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.

Metacognitive Training (MCT)

Combined intervention BEHAVIORAL

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

Combined intervention (water aerobics + MCT)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 55 years old
• Interested in participating in both water aerobics and MCT groups

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Parc Sanitari Sant Joan de Déu: collaborator
• Solidaritat Sant Joan de Déu: collaborator
• Fluidra: collaborator

Study Sites (1)

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

RECRUITING

Related Publications (1)

• Ochoa S, Verdaguer-Rodriguez M, Batlle N, Garreta F, Garcia B, Haro JM, Vila-Andreu E, Hernandez MJ, Escandell MJ, Munoz A, Vilamala S, Marcos S, Bassolas L, Pascua M, Ramos B; Thalassa Research Group. Efficacy of the combination of water aerobics and metacognitive training on psychological and physical health variables and their relationship with SP1 and SP4 biomarkers in people with psychosis: a study protocol. Front Psychol. 2024 Jun 11;15:1360004. doi: 10.3389/fpsyg.2024.1360004. eCollection 2024.

  PMID: 38919799 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Susana Ochoa, PhD

  Parc Sanitari Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Ochoa, PhD

CONTACT

936406350; susana.ochoa@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blind to the intervention recieved by the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 13, 2022
• Study Start: August 2, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

ES (1)