Clinical trial NCT05455593: Effectiveness of the Combination of Water Aerobics and Metacognitive Training
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Solidaritat Sant Joan de Déu
name: Fluidra
First posted: 2022-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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...)

Primary outcomes:
measure: Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline Stress Test at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline Molecular measures at 3 months
timeFrame: Baseline and 3-month follow-up
Secondary outcomes:
measure: Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline IPSAQ Internal, Personal and Situational Attributions Questionnaire at 3 months (McArthur, 1972; Bentall et al, 1991; Diez-Alegría, 2006)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline MATRICS Consensus Cognitive Battery at 3 months (Nuechterlein et al., 2008; Rodriguez-Jimenez et al., 2012)
timeFrame: Baseline and 3-month follow-up
measure: WAIS-IV (Weschler Adults Intelligence Scale, 1955)
timeFrame: Baseline
measure: Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline WHO-DAS 12, Psychiatric Disability Assessment Schedule at 3 months (WHO, 1988; Vázquez-Barquero JL, 2000)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015)
timeFrame: Baseline and 3-month follow-up
measure: Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999)
timeFrame: Baseline and 3-month follow-up
measure: 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)
timeFrame: Baseline and 3-month follow-up
measure: Change from Heart Rate at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Blood Pressure at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Weight at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Height at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Body Mass Index (BMI) at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Body Abdominal Girth at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Glucose Levels at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Total Cholesterol at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from HDL Cholesterol at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from LDL Cholesterol at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Parc Sanitari Sant Joan de Deu
name: Susana Ochoa, PhD
role: PRINCIPAL_INVESTIGATOR
References: