Effectiveness of the Combination of Water Aerobics and Metacognitive Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-02

Study Completion Date

2026-06-30

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.

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Detailed Description

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Conditions

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor will be blind to the intervention recieved by the participants

Study Groups

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Water aerobics

Aerobic exercises performed in a swimming pool.

Group Type ACTIVE_COMPARATOR

Water aerobics

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Metacognitive Training (MCT)

Intervention Type 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 (water aerobics + MCT)

Combination of water aerobics and MCT sessions.

Group Type EXPERIMENTAL

Combined intervention

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Combined intervention

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

Intervention Type BEHAVIORAL

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...)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No