Severe Mental DisorderNCT06315049
Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness
A study testing Music therapy in people with Severe Mental Disorder and Schizophrenia, run by Universitat Politècnica de València at 1 site in Spain.
Trial summary
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Severe Mental Disorder, Schizophrenia, Bipolar Disorder
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jun 2023to 31 Jul 2023
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with SMI (schizophrenia, bipolar disorder) according to the Diagnostic and Statistical Manual of Mental Disorders DSM-V-TR
- currently in outpatient psychiatric treatment in their corresponding mental health unit
- acceptance to enter the study (informed consent); if legally incapacitated, authorization from the patient's legal guardian
- ability to understand the questions in anxiety questionnaires
- between 35 and 50 years of age, to focus the study on a specific population (young adulthood above 35 years and middle adulthood) and to narrow the age range so that they can share common recall of musical memories
Who cannot join
- suffering from a dual pathology (diagnosis of mental illness and, at the same time, substance abuse) and who were also in the dependency phase
- affected by some type of degenerative disease (dementia, Alzheimer's, etc.)
- presence of positive psychotic symptoms or behavioral disorganization susceptible to admission in the mental health unit
- deafness
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session.
Read the detailed description
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with SMI (bipolar disorder and schizophrenia).
The general objective is to evaluate the effectiveness of the Nursing Interventions Classification (NIC) activity, known as Music Therapy, as a therapeutic modality complementary to psychopharmacological treatment for reducing anxiety in patients diagnosed with SMI. The specific research questions are:
Q1: How much do music interventions affect the objective values of vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR)) in people diagnosed with SMI? Q2: How much does the subjective perception of anxiety change after a music intervention with people diagnosed with SMI? This pilot study is quasi-experimental analytical research of type cross-sectional. It was conducted with outpatients diagnosed with SMI. All patients were recruited from a community mental health center in Valencia (Spain). Fourteen patients regularly attended an occupational activities rehabilitation workshop. All of them were recruited: after the workshop, they participated in the music therapy sessions. All the participants had been previously diagnosed with SMI (schizophrenia, bipolar disorder) by their psychiatrist. Ten participants lived with their parents, and four lived alone and lacked familiar support. None of the participants worked. All had total permanent disability, legally granted, and therefore could not carry out any work activity.
All patients who met the inclusion/exclusion criteria and voluntarily accepted to participate were recruited: 14 patients (3 people with bipolar disorder, 11 people with schizophrenia) participated in the study (with a total sample of 10 group sessions and 150 individual data collection interviews). None of the patients had any previous music therapy experience. All patients followed unique treatments, and this study was an opportunity to motivate their social interaction through music and to study its impact on anxiety.
The patients' psychiatrists determined the cognitive competency of the patients and decided the convenience of their participation.
The intervention was organized into ten 1-hour music therapy sessions at the outpatient level twice weekly. Patients' adherence to the music therapy sessions was 75%, which was more or less stable (standard deviation 15%).
- Conditions
- Severe Mental Disorder, Schizophrenia, Bipolar Disorder, Anxiety
- Being tested
- Music therapy
- Keywords
- Music therapy
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Music therapy sessions to reduce anxiety
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Experimental | It is formed from all the participants in the study. They participated in the music therapy sessions. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IDARE test
Inventario de la ansiedad rasgo-estado (IDARE) is the Spanish version of the State-Trait Anxiety Inventory (STAI), commonly used to obtain a meaningful measure of state anxiety (SA) and trait anxiety (TA).
Measured: 1 year
SBP
Systolic blood pressure
Measured: 1 year
DBP
Diastolic blood pressure
Measured: 1 year
HR
Heart rate
Measured: 1 year
RR
Respiratory rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start26 Jun 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Mental DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Politècnica de València
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Josep Francesc Silva Galiana, Universitat Politècnica de València
- Investigators
- Vanessa Ibáñez, PhD, Study director, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315049
- Sponsor's protocol ID
- 2023-ENFPOD-2621979
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibanez-Del Valle V, Sanchez-Martinez V, Silva J. Nurse-Implemented Music Therapy to Reduce Anxiety in Community-Dwelling Individuals with Severe Mental Illness: A Pilot Study. Nurs Rep. 2024 Mar 22;14(2):695-706. doi: 10.3390/nursrep14020053.
PubMed 38525699
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT06315049
- Acronym / sponsor ID
- 2023-ENFPOD-2621979
- Conditions
- Severe Mental Disorder, Schizophrenia, Bipolar Disorder, Anxiety
- Keywords
- Music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitat Politècnica de ValènciaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Mar 2024 (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.
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session.
Detailed description
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with SMI (bipolar disorder and schizophrenia).
The general objective is to evaluate the effectiveness of the Nursing Interventions Classification (NIC) activity, known as Music Therapy, as a therapeutic modality complementary to psychopharmacological treatment for reducing anxiety in patients diagnosed with SMI. The specific research questions are:
Q1: How much do music interventions affect the objective values of vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR)) in people diagnosed with SMI? Q2: How much does the subjective perception of anxiety change after a music intervention with people diagnosed with SMI? This pilot study is quasi-experimental analytical research of type cross-sectional. It was conducted with outpatients diagnosed with SMI. All patients were recruited from a community mental health center in Valencia (Spain). Fourteen patients regularly attended an occupational activities rehabilitation workshop. All of them were recruited: after the workshop, they participated in the music therapy sessions. All the participants had been previously diagnosed with SMI (schizophrenia, bipolar disorder) by their psychiatrist. Ten participants lived with their parents, and four lived alone and lacked familiar support. None of the participants worked. All had total permanent disability, legally granted, and therefore could not carry out any work activity.
All patients who met the inclusion/exclusion criteria and voluntarily accepted to participate were recruited: 14 patients (3 people with bipolar disorder, 11 people with schizophrenia) participated in the study (with a total sample of 10 group sessions and 150 individual data collection interviews). None of the patients had any previous music therapy experience. All patients followed unique treatments, and this study was an opportunity to motivate their social interaction through music and to study its impact on anxiety.
The patients' psychiatrists determined the cognitive competency of the patients and decided the convenience of their participation.
The intervention was organized into ten 1-hour music therapy sessions at the outpatient level twice weekly. Patients' adherence to the music therapy sessions was 75%, which was more or less stable (standard deviation 15%).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | Experimental | Other: Music therapyIt is formed from all the participants in the study. They participated in the music therapy sessions. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosed with SMI (schizophrenia, bipolar disorder) according to the Diagnostic and Statistical Manual of Mental Disorders DSM-V-TR
- currently in outpatient psychiatric treatment in their corresponding mental health unit
- acceptance to enter the study (informed consent); if legally incapacitated, authorization from the patient's legal guardian
- ability to understand the questions in anxiety questionnaires
- between 35 and 50 years of age, to focus the study on a specific population (young adulthood above 35 years and middle adulthood) and to narrow the age range so that they can share common recall of musical memories
Key exclusion criteria (4 listed)
- suffering from a dual pathology (diagnosis of mental illness and, at the same time, substance abuse) and who were also in the dependency phase
- affected by some type of degenerative disease (dementia, Alzheimer's, etc.)
- presence of positive psychotic symptoms or behavioral disorganization susceptible to admission in the mental health unit
- deafness
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 therapyMusic therapy sessions to reduce anxiety | Other | Music therapy group |
Primary outcome
IDARE test
Time frame: 1 year
Inventario de la ansiedad rasgo-estado (IDARE) is the Spanish version of the State-Trait Anxiety Inventory (STAI), commonly used to obtain a meaningful measure of state anxiety (SA) and trait anxiety (TA).
SBP
Time frame: 1 year
Systolic blood pressure
DBP
Time frame: 1 year
Diastolic blood pressure
HR
Time frame: 1 year
Heart rate
RR
Time frame: 1 year
Respiratory rate
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 18 Mar 2024.
- Derived from this study: PubMed 38525699Ibanez-Del Valle V, Sanchez-Martinez V, Silva J. Nurse-Implemented Music Therapy to Reduce Anxiety in Community-Dwelling Individuals with Severe Mental Illness: A Pilot Study. Nurs Rep. 2024 Mar 22;14(2):695-706. doi: 10.3390/nursrep14020053.
- Individual participant dataSharing planned: No
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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.
Vanessa Ibáñez, PhD study director
Universitat de València
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 in people with Severe Mental Disorder and Schizophrenia, run by Universitat Politècnica de València 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 5 inclusion and 4 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 18 Mar 2024. 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?
IDARE test (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315049, which also lists 1 linked publication.
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 18 Mar 2024.