Music Therapy for People With Schizophrenia and Relates Psychosis.
Primary Purpose
Schizophrenia; Psychosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Music therapy and treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia; Psychosis focused on measuring Music Therapy, Psychosis, Adjunct Therapy, Psychosocial Rehabilitation, Recovery
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
Sites / Locations
- Sergio Lacamara Cano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Music therapy Group
Control Non music therapy group
Arm Description
experimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT)
Group with usual treatment only (TAU).
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04777266
First Posted
February 5, 2021
Last Updated
May 31, 2023
Sponsor
State reference center for psychosocial care
Collaborators
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT04777266
Brief Title
Music Therapy for People With Schizophrenia and Relates Psychosis.
Official Title
The Music Therapy for People With Schizophrenia and Relates Psychosis: Effects on Symptoms, Self-esteem, Self-stigma, Social Cognition, Social Functioning and Quality of Live. Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State reference center for psychosocial care
Collaborators
University of Valencia
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis
Keywords
Music Therapy, Psychosis, Adjunct Therapy, Psychosocial Rehabilitation, Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Music therapy Group
Arm Type
Experimental
Arm Description
experimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT)
Arm Title
Control Non music therapy group
Arm Type
Active Comparator
Arm Description
Group with usual treatment only (TAU).
Intervention Type
Behavioral
Intervention Name(s)
Music therapy and treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
10 weeks
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
10 weeks
Title
World Health Organization Quality of Life-Short version (WHOQOL-BREF)
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sergio Lacamara Cano
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Music Therapy for People With Schizophrenia and Relates Psychosis.
We'll reach out to this number within 24 hrs