Severe Mental DisorderNCT07379996
"Pilot Study of Music Intervention for Recovery of People With Severe Mental Disorder in the Community"
A study testing Passive music therapy in an individual format 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 was to analyze the effect of music therapy on hope, quality of life, and social functioning in individuals with Severe Mental Disorder in the community. The main research questions were: Can music therapy increase the level of hope in individuals with Severe Mental Disorder? Can music therapy… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Severe Mental Disorder, Severe Mental Illness
- What is being tested?
- Passive music therapy in an individual format
- 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 Feb 2025to 19 Jun 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals aged 16 years or older.
- Individuals without severe hearing impairment.
- Individuals without cognitive deficits that would prevent them from reading or understanding the study documents.
Who cannot join
- Having a severe hearing impairment.
- Inability to read or understand the proposed questionnaires.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Mental Health Rehabilitation Unit of Cartagena
Cartagena, Murcia, 30203
About this study
Official title: "Music Therapy in the Recovery Process of Individuals With Severe Mental Disorder in the Community Setting: A Pilot Study."
The aim of this study was to analyze the effect of music therapy on hope, quality of life, and social functioning in individuals with Severe Mental Disorder in the community.
The main research questions were:
Read more
Can music therapy increase the level of hope in individuals with Severe Mental Disorder? Can music therapy improve the quality of life of individuals with Severe Mental Disorder? Can music therapy enhance the social functioning of individuals with Severe Mental Disorder?
Participants were users of a Community Mental Health Care Team called the Assertive Community Treatment Team.
A total of 12 music therapy sessions were conducted, each lasting 45-60 minutes. Participants selected the songs or sounds they wanted to listen to based on the session theme, followed by a dialogue between the participant and the nurse.
- Conditions
- Severe Mental Disorder, Severe Mental Illness
- Being tested
- Passive music therapy in an individual format
- Keywords
- Severe Mental Disorder, Hope, Music therapy, Social functioning, Quality of life, Severe mental illness, Mental health recovery, Recovery
- Medical subject headings
- Mental Disorders, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive music therapy in an individual formatBehavioural
The intervention was administered individually, and the authors based it on a review of the scientific literature on studies that evaluated the main proposed variables: quality of life, social functioning, and hope.
In general, participants selected the music they wished to listen to for each session, following the nurse's guidance, and a dialogue was then established between the participant and the nurse.
The intervention lasted approximately 20 weeks, with a weekly or biweekly frequency. The intervention consisted of 12 sessions, each lasting 45-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Severe Mental Disorder from an Assertive Community Treatment Team | Experimental | The study was conducted within a community-based service for individuals with Severe Mental Disorder, called the Assertive Community Treatment Team (ACT Team), located in the city of Cartagena, Spain.
The study participants were active users currently receiving care from this service. Receives: Behavioral: Passive music therapy in an individual format |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHOQOL-BREF - Quality of Life Scale
This self-administered questionnaire assesses an individual's quality of life across four domains (physical health, psychological health, social relationships, and environment). It also includes an evaluation of perceived general health and overall quality of life. The questionnaire consists of 26 items with five response options (1-5). The higher the score in each domain, the better the quality of life profile of the person being assessed.
Measured: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20)
Beck Hopelessness Scale (BHS)
This self-administered questionnaire assesses an individual's negative perceptions about the future and suicide risk. It consists of 20 items with true/false response options. The results indicate four levels of hopelessness: 0-3 (normal/asymptomatic), 4-8 (mild), 9-14 (moderate), and 15-20 (severe).
Measured: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20).
Social Functioning Scale (SFS)
The self-administered version of this scale assesses seven dimensions of social functioning:
Social isolation: 0 to 3 per item, with a total score range of 0-15. Interpersonal behavior: 4 items. First, items 1 and 2 are summed; if their combined score exceeds 3, a maximum of 3 is assigned. The remaining two items are scored from 0 to 3, resulting in a total score range of 0-9.
Prosocial activities: 22 items, scored 0 to 3, total score range 0-66. Leisure: 15 items, scored 0 to 3, total score range 0-45. Independence-performance: 13 items, scored 0 to 3, total score range 0-39. Independence-competence: 13 items, scored 1 to 3, total score range 13-39. Employment/occupation: A score of up to 6 points is possible if the patient feels capable of performing some type of work and is making frequent attempts to find employment.
It includes 78 items. Higher scores consistently indicate a higher level of social functioning in each domain.
Measured: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20).
Secondary outcomes (1)
Satisfaction with the received intervention
The participants completed a self-developed satisfaction survey to assess their level of satisfaction with the intervention, 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 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start3 Feb 2025
- Primary completion2 Jun 2025
- Study completion19 Jun 2025
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
- Pilot study with a quasi-experimental pre-test and post-test design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT07379996
- Sponsor's protocol ID
- CEI.24-93.TFM-A.VargasRubio
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Feb 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Music Therapy in the Recovery Process of Individuals With Severe Mental Disorder in the Community Setting: A Pilot Study."
- ClinicalTrials.gov ID
- NCT07379996
- Acronym / sponsor ID
- CEI.24-93.TFM-A.VargasRubio
- Conditions
- Severe Mental Disorder, Severe Mental Illness
- Keywords
- Severe Mental Disorder, Hope, Music therapy, Social functioning, Quality of life, Severe mental illness, Mental health recovery, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alejando Vargas RubioUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 2 Feb 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 was to analyze the effect of music therapy on hope, quality of life, and social functioning in individuals with Severe Mental Disorder in the community.
The main research questions were:
Can music therapy increase the level of hope in individuals with Severe Mental Disorder? Can music therapy improve the quality of life of individuals with Severe Mental Disorder? Can music therapy enhance the social functioning of individuals with Severe Mental Disorder?
Participants were users of a Community Mental Health Care Team called the Assertive Community Treatment Team.
A total of 12 music therapy sessions were conducted, each lasting 45-60 minutes. Participants selected the songs or sounds they wanted to listen to based on 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
- Pilot study with a quasi-experimental pre-test and post-test design
| Arm | Type | Receives |
|---|---|---|
| Individuals with Severe Mental Disorder from an Assertive Community Treatment Team | Experimental | Behavioral: Passive music therapy in an individual formatThe study was conducted within a community-based service for individuals with Severe Mental Disorder, called the Assertive Community Treatment Team (ACT Team), located in the city of Cartagena, Spain. The study participants were active users currently receiving care from this service. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 16 years or older.
- Individuals without severe hearing impairment.
- Individuals without cognitive deficits that would prevent them from reading or understanding the study documents.
Key exclusion criteria (2 listed)
- Having a severe hearing impairment.
- Inability to read or understand the proposed questionnaires.
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 |
|---|---|---|
| Passive music therapy in an individual formatThe intervention was administered individually, and the authors based it on a review of the scientific literature on studies that evaluated the main proposed variables: quality of life, social functioning, and hope. In general, participants selected the music they wished to listen to for each session, following the nurse's guidance, and a dialogue was then established between the participant and the nurse. The intervention lasted approximately 20 weeks, with a weekly or biweekly frequency. The intervention consisted of 12 sessions, each lasting 45-60 minutes. | Behavioural | Individuals with Severe Mental Disorder from an Assertive Community Treatment Team |
Primary outcome
WHOQOL-BREF - Quality of Life Scale
Time frame: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20)
This self-administered questionnaire assesses an individual's quality of life across four domains (physical health, psychological health, social relationships, and environment). It also includes an evaluation of perceived general health and overall quality of life. The questionnaire consists of 26 items with five response options (1-5). The higher the score in each domain, the better the quality of life profile of the person being assessed.
Beck Hopelessness Scale (BHS)
Time frame: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20).
This self-administered questionnaire assesses an individual's negative perceptions about the future and suicide risk. It consists of 20 items with true/false response options. The results indicate four levels of hopelessness: 0-3 (normal/asymptomatic), 4-8 (mild), 9-14 (moderate), and 15-20 (severe).
Social Functioning Scale (SFS)
Time frame: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20).
The self-administered version of this scale assesses seven dimensions of social functioning: Social isolation: 0 to 3 per item, with a total score range of 0-15. Interpersonal behavior: 4 items. First, items 1 and 2 are summed; if their combined score exceeds 3, a maximum of 3 is assigned. The remaining two items are scored from 0 to 3, resulting in a total score range of 0-9. Prosocial activities: 22 items, scored 0 to 3, total score range 0-66. Leisure: 15 items, scored 0 to 3, total score range 0-45. Independence-performance: 13 items, scored 0 to 3, total score range 0-39. Independence-competence: 13 items, scored 1 to 3, total score range 13-39. Employment/occupation: A score of up to 6 points is possible if the patient feels capable of performing some type of work and is making frequent attempts to find employment. It includes 78 items. Higher scores consistently indicate a higher level of social functioning in each domain.
1 secondary outcome
Satisfaction with the received intervention
Time frame: At the end of the intervention, in Week 20.
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 Feb 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 Passive music therapy in an individual format 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 3 inclusion and 2 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 Feb 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?
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?
WHOQOL-BREF - Quality of Life Scale (time frame: This questionnaire was administered at three time points: at baseline (Day 1 of the intervention), at mid-intervention (around Week 10), and at the end of the intervention (Week 20)). 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 Feb 2026.