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

NCT07470346 | Active Not Recruiting

• 1 other identifier: 2025-12-13-HCUVA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Severe Mental Disorder; Severe Mental Illness

Keywords

Music therapy; Mental health recovery; Anxiety; Anxiety disorders; Psychological stress; Severe Mental Disorder; Severe Mental Illness

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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

  At the end of the intervention, in week 15.

Study Arms (1)

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.

Behavioral: Combined music therapy intervention (active and receptive)

Interventions

Combined music therapy intervention (active and receptive) BEHAVIORAL

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.

Individuals with Severe Mental Disorder admitted to a Regional Medium-Stay Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alejando Vargas Rubio: lead

Study Sites (1)

Román Alberca Psychiatric Hospital

El Palmar, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Mental Disorders; Anxiety Disorders; Stress, Psychological

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mental Health Nurse Specialist

Model Details: Study with a quasi-experimental pre-test and post-test design

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 3, 2026
• Primary Completion: June 16, 2026
• Study Completion: June 16, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

ES (1)