Effectiveness of the Combination of Water Aerobics and Metacognitive Training

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline Stress Test at 3 months [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline Molecular measures at 3 months [Срок оценки: Baseline and 3-month follow-up]

Вторичные конечные точки (12)

• Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007) [Срок оценки: 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) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021) [Срок оценки: 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) [Срок оценки: Baseline and 3-month follow-up]
• WAIS-IV (Weschler Adults Intelligence Scale, 1955) [Срок оценки: Baseline]
• Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976) [Срок оценки: 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) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015) [Срок оценки: Baseline and 3-month follow-up]
• Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999) [Срок оценки: Baseline and 3-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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...)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT05455593 · PIC-155-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗