Music Therapy for People With Schizophrenia and Relates Psychosis.

NCT ID: NCT04777266

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-04-30

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.

Conditions

Schizophrenia; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Music therapy Group

experimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT)

Group Type: EXPERIMENTAL

Music therapy and treatment as usual

Intervention Type: BEHAVIORAL

The session-based intervention programme was designed with an integrated and multimodal perspective of music therapy \[37\], which allows the combination of active and passive activities together with focuses and perspectives based on empirical evidence \[38\]. It was implemented using a process-based approach, adapting content to different phases in the process: initial contact, managing resistance, confidence building, relationships, awareness, and closure. The central focus is on the patient and to adapt and remain flexible in the sessions in accordance with the capabilities and needs of the group members. Different perspectives are integrated via nonverbal communication. The layout and any changes to the setting are made in a gradual way in keeping with the process to foster feelings of security and belonging. Sessions begin with a brief period of breathing which then moves into warming-up and free-expression using instruments, followed by the central activity and the closure.

Control Non music therapy group

Group with usual treatment only (TAU).

Group Type: ACTIVE_COMPARATOR

Music therapy and treatment as usual

Intervention Type: BEHAVIORAL

The session-based intervention programme was designed with an integrated and multimodal perspective of music therapy \[37\], which allows the combination of active and passive activities together with focuses and perspectives based on empirical evidence \[38\]. It was implemented using a process-based approach, adapting content to different phases in the process: initial contact, managing resistance, confidence building, relationships, awareness, and closure. The central focus is on the patient and to adapt and remain flexible in the sessions in accordance with the capabilities and needs of the group members. Different perspectives are integrated via nonverbal communication. The layout and any changes to the setting are made in a gradual way in keeping with the process to foster feelings of security and belonging. Sessions begin with a brief period of breathing which then moves into warming-up and free-expression using instruments, followed by the central activity and the closure.

Interventions

Music therapy and treatment as usual

The session-based intervention programme was designed with an integrated and multimodal perspective of music therapy \[37\], which allows the combination of active and passive activities together with focuses and perspectives based on empirical evidence \[38\]. It was implemented using a process-based approach, adapting content to different phases in the process: initial contact, managing resistance, confidence building, relationships, awareness, and closure. The central focus is on the patient and to adapt and remain flexible in the sessions in accordance with the capabilities and needs of the group members. Different perspectives are integrated via nonverbal communication. The layout and any changes to the setting are made in a gradual way in keeping with the process to foster feelings of security and belonging. Sessions begin with a brief period of breathing which then moves into warming-up and free-expression using instruments, followed by the central activity and the closure.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: collaborator

State reference center for psychosocial care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sergio Lacamara Cano

Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sergio Lacamara Cano

Valencia, , Spain

Countries

Spain

Other Identifiers

StateReferenceCenter

Identifier Type: -

Identifier Source: org_study_id