Schizophrenia; PsychosisNCT04777266
Music Therapy for People With Schizophrenia and Relates Psychosis.
A study testing Music therapy and treatment as usual in people with Schizophrenia; Psychosis, run by State reference center for psychosocial care at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia; Psychosis
- What is being tested?
- Music therapy and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Music therapy and treatment as usual
- Keywords
- Music Therapy, Psychosis, Adjunct Therapy, Psychosocial Rehabilitation, Recovery
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy and treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Music therapy Group | Experimental | experimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT) Receives: Behavioral: Music therapy and treatment as usual |
| Control Non music therapy group | Active comparator | Group with usual treatment only (TAU). Receives: Behavioral: Music therapy and treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Sep 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State reference center for psychosocial care
- Sponsor type
- Other government
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Sergio Lacamara Cano, State reference center for psychosocial care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777266
- Sponsor's protocol ID
- StateReferenceCenter
- Status last verified
- May 2023
- First submitted
- 5 Feb 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04777266
- Acronym / sponsor ID
- StateReferenceCenter
- Conditions
- Schizophrenia; Psychosis
- Keywords
- Music Therapy, Psychosis, Adjunct Therapy, Psychosocial Rehabilitation, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State reference center for psychosocial careOther government
- Collaborators
- University of Valencia
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Music therapy Group | Experimental | Behavioral: Music therapy and treatment as usualexperimental group receiving the MT programme in addition to their usual treatment (pharmacological and psychosocial) (TAU + MT) |
| Control Non music therapy group | Active comparator | Behavioral: Music therapy and treatment as usualGroup with usual treatment only (TAU). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- Previous brain damage
- Substance abuse in the last year
- Display of mood disorders
- Organic or substance based mental disorders
- Disrupted symptomatology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy and treatment as usualThe 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. | Behavioural | Control Non music therapy group, Experimental Music therapy Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and treatment as usual in people with Schizophrenia; Psychosis, run by State reference center for psychosocial care at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.