CClinicalTrials.gg
CompletedNCT07379996Updated Feb 2, 2026

"Pilot Study of Music Intervention for Recovery of People With Severe Mental Disorder in the Community"

An interventional study of Passive music therapy in an individual format in Severe Mental Disorder and Severe Mental Illness, sponsored by Alejando Vargas Rubio. Completed at 1 site in Spain. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Alejando Vargas Rubio · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 12 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Alejando Vargas Rubio is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Having a severe hearing impairment.
  • Inability to read or understand the proposed questionnaires.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Individuals with Severe Mental Disorder from an Assertive Community Treatment Team

    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.

    Behavioral: Passive music therapy in an individual format

Interventions

  • BehavioralPassive music therapy in an individual format

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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)

  2. 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).

    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).

  3. 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.

    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).

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).

    Time frame: At the end of the intervention, in Week 20.

07

Study locations

1 site
  • Mental Health Rehabilitation Unit of Cartagena
    Cartagena, Murcia 30203, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07379996
Lead sponsor
Alejando Vargas Rubio
Responsible party
Alejando Vargas Rubio (Mental Health Nurse Specialist, Universidad de Murcia) — Sponsor-investigator
First posted
Feb 2, 2026
Start date
Feb 3, 2025
Primary completion
Jun 2, 2025
Completion
Jun 19, 2025
Last update
Feb 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion