Effectiveness of the Combination of Water Aerobics and Metacognitive Training
ConditionPsychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFundació Sant Joan de Déu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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...)
Trial design
Design model
Parallel
Treatments tested in this trial
Water aerobics
Behavioral1-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)
Behavioral1-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
BehavioralPatients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Water aerobicsActive comparator 1 intervention
Group B: Metacognitive Training (MCT)Active comparator 1 intervention
Group C: Combined intervention (water aerobics + MCT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 3-month follow-up2
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.
Time frame
Baseline and 3-month follow-up3
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.
Time frame
Baseline and 3-month follow-up4
Change from Baseline Stress Test at 3 months
Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry.
Time frame
Baseline and 3-month follow-upSecondary outcomes
1
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.
Time frame
Baseline and 3-month follow-up2
Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)
Depressive symptoms
Time frame
Baseline and 3-month follow-up3
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.
Time frame
Baseline and 3-month follow-up4
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.
Time frame
Baseline and 3-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
Parc Sanitari Sant Joan de Déu
Collaborator
Solidaritat Sant Joan de Déu
Collaborator
Fluidra
Collaborator
Source ClinicalTrials.gov