Severe Mental DisorderNCT07470346
Musical Intervention for the Management of Anxiety and Stress in People With Severe Mental Disorder in a Medium-stay Unit.
A study testing Combined music therapy intervention (active and receptive) in people with Severe Mental Disorder and Severe Mental Illness, run by Alejando Vargas Rubio at 1 site in Spain.
Trial summary
The aim of this study is to analyze the influence of music therapy on perceived anxiety and stress, as well as its effect on the recovery process in individuals with Severe Mental Disorder who are admitted to a Regional Medium-Stay Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Disorder, Severe Mental Illness
- What is being tested?
- Combined music therapy intervention (active and receptive)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2026to 16 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years or older.
- Individuals without severe hearing impairment.
- Individuals without cognitive deficits that would prevent them from reading or understanding the proposed documents.
- Individuals not in a state of psychopathological decompensation.
Who cannot join
- Individuals under 18 years of age.
- Individuals with severe hearing impairment.
- Individuals with cognitive deficits that prevent them from reading or understanding the proposed questionnaires.
- Individuals in a state of psychopathological decompensation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy in the Management of Anxiety and Stress in the Recovery Process of People With Severe Mental Disorder in a Regional Medium-Stay Unit.
The aim of this study is to analyze the influence of music therapy on perceived anxiety and stress, as well as its effect on the recovery process in individuals with Severe Mental Disorder who are admitted to a Regional Medium-Stay Unit.
The main questions to be addressed are:
Read more
Can music therapy produce a significant difference in anxiety levels in people with Severe Mental Disorder? Can music therapy produce a significant effect on perceived stress in people with Severe Mental Disorder? Can music therapy lead to a significant improvement in recovery process indicators in people with Severe Mental Disorder? Can a relationship be objectively established between a reduction in anxiety and perceived stress levels and an increase in recovery process indicators?
A total of 15 sessions will be carried out, and each session will last 60 minutes.
The participants will select the songs, rhythms, or sounds they want to choose according to the session theme, followed by a dialogue between the participant and the nurse.
- Conditions
- Severe Mental Disorder, Severe Mental Illness
- Being tested
- Combined music therapy intervention (active and receptive)
- Keywords
- Music therapy, Mental health recovery, Anxiety, Anxiety disorders, Psychological stress, Severe Mental Disorder, Severe Mental Illness
- Medical subject headings
- Mental Disorders, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined music therapy intervention (active and receptive)Behavioural
A combined music therapy intervention (active and receptive) will be conducted in a group format. In each session, participants will select the songs they wish to listen to in relation to the topic being addressed. The songs will then be played, followed by a dialogue between the users and the professionals.
The intervention will consist of 15 sessions held weekly (over 15 weeks), each lasting approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Severe Mental Disorder admitted to a Regional Medium-Stay Unit | Experimental | The study will be conducted in a Regional Medium-Stay Unit (URME) belonging to the Murcia Health Service and located in the Román Alberca Hospital complex in El Palmar (Murcia), Spain. It is a care service for people with Severe Mental Disorder who, due to circumstances derived from their mental state or arising within their social context, experience difficulties maintaining their integration in the community or receiving care in an outpatient setting, thus requiring a period of medium- or long-term hospitalization. Receives: Behavioral: Combined music therapy intervention (active and receptive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI Questionnaire (State-Trait Anxiety Inventory)
This self-administered questionnaire assesses two aspects related to anxiety: state anxiety and trait anxiety. It consists of 20 items for each subscale (state anxiety and trait anxiety), with 4 response options ranging from 0 (Not at all) to 3 (Very much). Higher scores indicate a greater level of anxiety. The Spanish validated version shows a Cronbach's alpha of 0.9 for trait anxiety and 0.94 for state anxiety.
Measured: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).
Perceived Stress Scale (PSS) Questionnaire
This self-administered questionnaire assesses the level of perceived stress. It consists of 14 items with 5 response options ranging from 0 (Never) to 4 (Very often). Higher scores indicate a higher level of perceived stress. The validated Spanish version shows a Cronbach's alpha of 0.81
Measured: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).
Questionnaire about the Process of Recovery (QPR-15-SP)
This self-administered questionnaire assesses changes in the different dimensions of the recovery process. It consists of 15 items, each rated on a Likert scale from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate a greater level of recovery.
The validated Spanish version of this scale shows a McDonald's Omega coefficient of 0.93 and a Cronbach's alpha coefficient of 0.92
Measured: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).
Secondary outcomes (1)
Satisfaction with the intervention received
Participants will complete a self-developed satisfaction survey to assess their level of satisfaction with the intervention. Satisfaction will be measured using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied).
Measured: At the end of the intervention, in week 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start3 Mar 2026
- Primary completion16 Jun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Study with a quasi-experimental pre-test and post-test design
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alejando Vargas Rubio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alejando Vargas Rubio, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470346
- Sponsor's protocol ID
- 2025-12-13-HCUVA
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy in the Management of Anxiety and Stress in the Recovery Process of People With Severe Mental Disorder in a Regional Medium-Stay Unit.
- ClinicalTrials.gov ID
- NCT07470346
- Acronym / sponsor ID
- 2025-12-13-HCUVA
- Conditions
- Severe Mental Disorder, Severe Mental Illness
- Keywords
- Music therapy, Mental health recovery, Anxiety, Anxiety disorders, Psychological stress, Severe Mental Disorder, Severe Mental Illness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Alejando Vargas RubioUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 13 Mar 2026 (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.
The aim of this study is to analyze the influence of music therapy on perceived anxiety and stress, as well as its effect on the recovery process in individuals with Severe Mental Disorder who are admitted to a Regional Medium-Stay Unit.
The main questions to be addressed are:
Can music therapy produce a significant difference in anxiety levels in people with Severe Mental Disorder? Can music therapy produce a significant effect on perceived stress in people with Severe Mental Disorder? Can music therapy lead to a significant improvement in recovery process indicators in people with Severe Mental Disorder? Can a relationship be objectively established between a reduction in anxiety and perceived stress levels and an increase in recovery process indicators?
A total of 15 sessions will be carried out, and each session will last 60 minutes.
The participants will select the songs, rhythms, or sounds they want to choose according to the session theme, followed by a dialogue between the participant and the nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study with a quasi-experimental pre-test and post-test design
| Arm | Type | Receives |
|---|---|---|
| Individuals with Severe Mental Disorder admitted to a Regional Medium-Stay Unit | Experimental | Behavioral: Combined music therapy intervention (active and receptive)The study will be conducted in a Regional Medium-Stay Unit (URME) belonging to the Murcia Health Service and located in the Román Alberca Hospital complex in El Palmar (Murcia), Spain. It is a care service for people with Severe Mental Disorder who, due to circumstances derived from their mental state or arising within their social context, experience difficulties maintaining their integration in the community or receiving care in an outpatient setting, thus requiring a period of medium- or long-term hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18 years or older.
- Individuals without severe hearing impairment.
- Individuals without cognitive deficits that would prevent them from reading or understanding the proposed documents.
- Individuals not in a state of psychopathological decompensation.
Key exclusion criteria (4 listed)
- Individuals under 18 years of age.
- Individuals with severe hearing impairment.
- Individuals with cognitive deficits that prevent them from reading or understanding the proposed questionnaires.
- Individuals in a state of psychopathological decompensation.
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 |
|---|---|---|
| Combined music therapy intervention (active and receptive)A combined music therapy intervention (active and receptive) will be conducted in a group format. In each session, participants will select the songs they wish to listen to in relation to the topic being addressed. The songs will then be played, followed by a dialogue between the users and the professionals. The intervention will consist of 15 sessions held weekly (over 15 weeks), each lasting approximately one hour. | Behavioural | Individuals with Severe Mental Disorder admitted to a Regional Medium-Stay Unit |
Primary outcome
STAI Questionnaire (State-Trait Anxiety Inventory)
Time frame: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).
This self-administered questionnaire assesses two aspects related to anxiety: state anxiety and trait anxiety. It consists of 20 items for each subscale (state anxiety and trait anxiety), with 4 response options ranging from 0 (Not at all) to 3 (Very much). Higher scores indicate a greater level of anxiety. The Spanish validated version shows a Cronbach's alpha of 0.9 for trait anxiety and 0.94 for state anxiety.
Perceived Stress Scale (PSS) Questionnaire
Time frame: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).
This self-administered questionnaire assesses the level of perceived stress. It consists of 14 items with 5 response options ranging from 0 (Never) to 4 (Very often). Higher scores indicate a higher level of perceived stress. The validated Spanish version shows a Cronbach's alpha of 0.81
Questionnaire about the Process of Recovery (QPR-15-SP)
Time frame: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).
This self-administered questionnaire assesses changes in the different dimensions of the recovery process. It consists of 15 items, each rated on a Likert scale from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate a greater level of recovery. The validated Spanish version of this scale shows a McDonald's Omega coefficient of 0.93 and a Cronbach's alpha coefficient of 0.92
1 secondary outcome
Satisfaction with the intervention received
Time frame: At the end of the intervention, in week 15.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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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 Combined music therapy intervention (active and receptive) in people with Severe Mental Disorder and Severe Mental Illness, run by Alejando Vargas Rubio 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 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
STAI Questionnaire (State-Trait Anxiety Inventory) (time frame: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).). 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 13 Mar 2026.