Music Therapy for People With Schizophrenia and Relates Psychosis.

NCT04777266 | Completed

• 1 other identifier: StateReferenceCenter
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychosis

Keywords

Music Therapy; Psychosis; Adjunct Therapy; Psychosocial Rehabilitation; Recovery

Outcome Measures

Primary Outcomes (3)

• Positive and Negative Syndrome Scale (PANSS)

  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.

  10 weeks

• State-Trait Anxiety Inventory (STAI)

  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.

  10 weeks

• World Health Organization Quality of Life-Short version (WHOQOL-BREF)

  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.

  10 weeks

Study Arms (2)

Experimental Music therapy Group

EXPERIMENTAL

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

Behavioral: Music therapy and treatment as usual

Control Non music therapy group

ACTIVE COMPARATOR

Group with usual treatment only (TAU).

Behavioral: Music therapy and treatment as usual

Interventions

Music therapy and treatment as usual 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; Experimental Music therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• State reference center for psychosocial care: lead
• University of Valencia: collaborator

Study Sites (1)

Sergio Lacamara Cano

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Music Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: March 2, 2021
• Study Start: September 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

ES (1)