- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777266
Music Therapy for People With Schizophrenia and Relates Psychosis.
May 31, 2023 updated by: Sergio Lacamara Cano, State reference center for psychosocial care
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Valencia, Spain, 46015
- Sergio Lacamara Cano
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Music therapy Group
experimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT)
|
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.
|
Active Comparator: Control Non music therapy group
Group with usual treatment only (TAU).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 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.
|
10 weeks
|
State-Trait Anxiety Inventory (STAI)
Time Frame: 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.
|
10 weeks
|
World Health Organization Quality of Life-Short version (WHOQOL-BREF)
Time Frame: 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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
March 2, 2021
Study Record Updates
Last Update Posted (Estimated)
June 2, 2023
Last Update Submitted That Met QC Criteria
May 31, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- StateReferenceCenter
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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