Music Therapy for People With Schizophrenia and Relates Psychosis.

Not Applicable

Completed

• Conditions: Schizophrenia; Psychosis
• Interventions: Behavioral: Music therapy and treatment as usual

• Registration Number: NCT04777266
• Lead Sponsor: State reference center for psychosocial care

Brief Summary

Treatment of symptoms, rehabilitation of cognitive deficits, improvement of social functioning and quality of life in schizophrenia and other psychoses are approached through a comprehensive strategy that combines psychopharmacology with psychosocial interventions. However, despite the efficacy of these interventions, this is not the same in all patients, and a large percentage do not achieve functional recovery.

Detailed Description

The aim of this research is to carry out a randomized trial on the effects of a music therapy (MT) program, implemented in addition to the usual pharmacological and psychosocial rehabilitation (TAU), on symptoms, self-esteem, internalized stigma, social cognition, social functioning and the quality of life in these patients.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The patients will be diagnosed with schizophrenia or schizoaffective disorder in accordance with DSM-IV-TR criteria using the Structured Clinical Interview for DSM-IV-TR (SCID-I).
• The patients will all clinically stable with a diagnosis of schizophrenia and regularly attended in the state approved centre for psychosocial attention CREAP (Centro de Referencia Estatal para la Atención Psicosocial) in Valencia (Spain).

Exclusion Criteria

• Previous brain damage
• Substance abuse in the last year
• Display of mood disorders
• Organic or substance based mental disorders
• Disrupted symptomatology
• Serious symptoms with difficulty in understanding the implications of informed consent and not replying in the interviews and assessment questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Non music therapy group	Music therapy and treatment as usual	Group with usual treatment only (TAU).
Experimental Music therapy Group	Music therapy and treatment as usual	experimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT)

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI)	10 weeks	The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.Scores range from 20 to 80, with higher scores correlating with greater anxiety.
World Health Organization Quality of Life-Short version (WHOQOL-BREF)	10 weeks	The WHOQOL-BREF contains 24 questions covering 4 domains plus two questions related to overall quality of life and satisfaction with health. Highes scores represent higher quality of life.
Positive and Negative Syndrome Scale (PANSS)	10 weeks	Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms.

Trial Locations

Locations (1)

Sergio Lacamara Cano; 🇪🇸 Valencia, Spain