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

Overview

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.

Interventions

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

Primary outcome measures

• 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]
• Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987) [Time frame: Baseline and 3-month follow-up]
• 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]
• Change from Baseline Stress Test at 3 months [Time frame: Baseline and 3-month follow-up]
• Change from Baseline Molecular measures at 3 months [Time frame: Baseline and 3-month follow-up]

Secondary outcome measures (12)

• 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]
• Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996) [Time frame: Baseline and 3-month follow-up]
• Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007) [Time frame: 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) [Time frame: Baseline and 3-month follow-up]
• Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995) [Time frame: Baseline and 3-month follow-up]
• Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021) [Time frame: Baseline and 3-month follow-up]
• 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]
• WAIS-IV (Weschler Adults Intelligence Scale, 1955) [Time frame: Baseline]
• Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976) [Time frame: Baseline and 3-month follow-up]
• 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]
• Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015) [Time frame: Baseline and 3-month follow-up]
• Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999) [Time frame: Baseline and 3-month follow-up]

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...)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Parc Sanitari Sant Joan de Déu — Sant Boi de Llobregat

Publications

• 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 PMID 38919799

Identifiers

NCT: NCT05455593 · PIC-155-21

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗