Effectiveness of the Combination of Water Aerobics and Metacognitive Training

Fundació Sant Joan de Déu

Status: Enrolling

Conditions: Psychosis

Treatments: Behavioral: Water aerobics; Behavioral: Metacognitive Training (MCT); Behavioral: Combined intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05455593

PIC-155-21

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Water aerobics

Active Comparator group

Description:

Aerobic exercises performed in a swimming pool.

Treatment:

Behavioral: Water aerobics

Metacognitive Training (MCT)

Active Comparator group

Description:

Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation.

Treatment:

Behavioral: Metacognitive Training (MCT)

Combined intervention (water aerobics + MCT)

Experimental group

Description:

Combination of water aerobics and MCT sessions.

Treatment:

Behavioral: Combined intervention