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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07470346
Enrollment
12
Registered
2026-03-13
Start date
2026-03-03
Completion date
2026-06-16
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mental Disorder, Severe Mental Illness

Keywords

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

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.

Interventions

BEHAVIORALCombined 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.

Sponsors

Alejando Vargas Rubio
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Study with a quasi-experimental pre-test and post-test design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
STAI Questionnaire (State-Trait Anxiety Inventory)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) QuestionnaireThis 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)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

Secondary

MeasureTime frameDescription
Satisfaction with the intervention receivedAt 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026