Musical Intervention for the Management of Anxiety and Stress in People With Severe Mental Disorder in a Medium-stay Unit.

March 9, 2026 updated by: Alejando Vargas Rubio

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:

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Román Alberca Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individuals with Severe Mental Disorder admitted to a Regional Medium-Stay Unit
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the intervention received
Time Frame: At the end of the intervention, in week 15.
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).
At the end of the intervention, in week 15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alejando Vargas Rubio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2026

Primary Completion (Estimated)

June 16, 2026

Study Completion (Estimated)

June 16, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-12-13-HCUVA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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