Back to resultsEffectiveness of the Combination of Water Aerobics and Metacognitive Training
Primary Purpose
Psychosis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Water aerobics
Metacognitive Training (MCT)
Combined intervention
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis
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...)
Sites / Locations
- Parc Sanitari Sant Joan de DéuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Water aerobics
Metacognitive Training (MCT)
Combined intervention (water aerobics + MCT)
Arm Description
Aerobic exercises performed in a swimming pool.
Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation.
Combination of water aerobics and MCT sessions.
Outcomes
Primary Outcome Measures
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.
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.
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.
Change from Baseline Stress Test at 3 months
Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry.
Change from Baseline Molecular measures at 3 months
Protein levels of SP1 and SP4 biomarkers transcription factor levels in peripheral blood mononuclear cells (PBMCs). mRNA expression levels of SP1 and SP4 biomarkers transcription factors in PBMCs.
Secondary Outcome Measures
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.
Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)
Depressive symptoms
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.
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.
Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)
Theory of mind
Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Facial emotion recognition
Change from Baseline MATRICS Consensus Cognitive Battery at 3 months (Nuechterlein et al., 2008; Rodriguez-Jimenez et al., 2012)
Verbal processing speed, verbal fluency, attention, working memory, verbal learning and memory, visual learning and memory, reasoning, problem solving.
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Premorbid IQ assessed with the Vocabulary subscale
Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)
General functioning in a scale of 0-100
Change from Baseline WHO-DAS 12, Psychiatric Disability Assessment Schedule at 3 months (WHO, 1988; Vázquez-Barquero JL, 2000)
Self-administered 12-item disability assessment
Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015)
Self-administered 14-item scale to assess self-stigma
Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999)
Self-administered 5-item to assess general quality of life
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)
3 items to assess awareness of having a mental illness, awareness of medication effects and awareness of social consequences of having a mental illness, in a scale of 0-15. Higher scores mean a worse outcome.
Change from Heart Rate at 3 months
Beats per minute (bpm)
Change from Blood Pressure at 3 months
Millimetre of mercury (mmHg)
Change from Weight at 3 months
Kilogram (Kg)
Change from Height at 3 months
Centimetre (cm)
Change from Body Mass Index (BMI) at 3 months
Weight and height will be combined to report BMI in kg/m^2
Change from Body Abdominal Girth at 3 months
Centimetre (cm)
Change from Glucose Levels at 3 months
Milligrams per decilitre (mg/dL)
Change from Total Cholesterol at 3 months
Milligrams per decilitre (mg/dL)
Change from HDL Cholesterol at 3 months
Milligrams per decilitre (mg/dL)
Change from LDL Cholesterol at 3 months
Milligrams per decilitre (mg/dL)
Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months
Intensity of physical activity and sitting time
Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months
Sleep quality
Full Information
NCT ID
NCT05455593
First Posted
June 13, 2022
Last Updated
July 7, 2022
Sponsor
Fundació Sant Joan de Déu
Collaborators
Parc Sanitari Sant Joan de Déu, Solidaritat Sant Joan de Déu, Fluidra
1. Study Identification
Unique Protocol Identification Number
NCT05455593
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Parc Sanitari Sant Joan de Déu, Solidaritat Sant Joan de Déu, Fluidra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blind to the intervention recieved by the participants
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Water aerobics
Arm Type
Active Comparator
Arm Description
Aerobic exercises performed in a swimming pool.
Arm Title
Metacognitive Training (MCT)
Arm Type
Active Comparator
Arm Description
Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation.
Arm Title
Combined intervention (water aerobics + MCT)
Arm Type
Experimental
Arm Description
Combination of water aerobics and MCT sessions.
Intervention Type
Behavioral
Intervention Name(s)
Water aerobics
Intervention Description
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
Intervention Name(s)
Metacognitive Training (MCT)
Intervention Description
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
Intervention Name(s)
Combined intervention
Intervention Description
Patients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.
Primary Outcome Measure Information:
Title
Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Description
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-up
Title
Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
Description
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-up
Title
Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021)
Description
Measure of five cognitive biases (30 items): jumping to conclusions, intentionalising, catastrophising, emotional reasoning, and dichotomous thinking.
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline Stress Test at 3 months
Description
Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry.
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline Molecular measures at 3 months
Description
Protein levels of SP1 and SP4 biomarkers transcription factor levels in peripheral blood mononuclear cells (PBMCs). mRNA expression levels of SP1 and SP4 biomarkers transcription factors in PBMCs.
Time Frame
Baseline and 3-month follow-up
Secondary Outcome Measure Information:
Title
Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995)
Description
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-up
Title
Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)
Description
Depressive symptoms
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)
Description
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-up
Title
Change from Baseline IPSAQ Internal, Personal and Situational Attributions Questionnaire at 3 months (McArthur, 1972; Bentall et al, 1991; Diez-Alegría, 2006)
Description
Attributional Style, including externalizing and personalizing bias subscales.
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)
Description
Theory of mind
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Description
Facial emotion recognition
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline MATRICS Consensus Cognitive Battery at 3 months (Nuechterlein et al., 2008; Rodriguez-Jimenez et al., 2012)
Description
Verbal processing speed, verbal fluency, attention, working memory, verbal learning and memory, visual learning and memory, reasoning, problem solving.
Time Frame
Baseline and 3-month follow-up
Title
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Description
Premorbid IQ assessed with the Vocabulary subscale
Time Frame
Baseline
Title
Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)
Description
General functioning in a scale of 0-100
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline WHO-DAS 12, Psychiatric Disability Assessment Schedule at 3 months (WHO, 1988; Vázquez-Barquero JL, 2000)
Description
Self-administered 12-item disability assessment
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015)
Description
Self-administered 14-item scale to assess self-stigma
Time Frame
Baseline and 3-month follow-up
Title
Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999)
Description
Self-administered 5-item to assess general quality of life
Time Frame
Baseline and 3-month follow-up
Title
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)
Description
3 items to assess awareness of having a mental illness, awareness of medication effects and awareness of social consequences of having a mental illness, in a scale of 0-15. Higher scores mean a worse outcome.
Time Frame
Baseline and 3-month follow-up
Title
Change from Heart Rate at 3 months
Description
Beats per minute (bpm)
Time Frame
Baseline and 3-month follow-up
Title
Change from Blood Pressure at 3 months
Description
Millimetre of mercury (mmHg)
Time Frame
Baseline and 3-month follow-up
Title
Change from Weight at 3 months
Description
Kilogram (Kg)
Time Frame
Baseline and 3-month follow-up
Title
Change from Height at 3 months
Description
Centimetre (cm)
Time Frame
Baseline and 3-month follow-up
Title
Change from Body Mass Index (BMI) at 3 months
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
Baseline and 3-month follow-up
Title
Change from Body Abdominal Girth at 3 months
Description
Centimetre (cm)
Time Frame
Baseline and 3-month follow-up
Title
Change from Glucose Levels at 3 months
Description
Milligrams per decilitre (mg/dL)
Time Frame
Baseline and 3-month follow-up
Title
Change from Total Cholesterol at 3 months
Description
Milligrams per decilitre (mg/dL)
Time Frame
Baseline and 3-month follow-up
Title
Change from HDL Cholesterol at 3 months
Description
Milligrams per decilitre (mg/dL)
Time Frame
Baseline and 3-month follow-up
Title
Change from LDL Cholesterol at 3 months
Description
Milligrams per decilitre (mg/dL)
Time Frame
Baseline and 3-month follow-up
Title
Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months
Description
Intensity of physical activity and sitting time
Time Frame
Baseline and 3-month follow-up
Title
Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months
Description
Sleep quality
Time Frame
Baseline and 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Ochoa, PhD
Phone
936406350
Ext
12538
Email
susana.ochoa@sjd.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Ochoa, PhD
Organizational Affiliation
Parc Sanitari Sant Joan de Deu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Sanitari Sant Joan de Déu
City
Sant Boi De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Ochoa, PhD
Phone
936406350
Ext
12538
Email
susana.ochoa@sjd.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effectiveness of the Combination of Water Aerobics and Metacognitive Training
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