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NCT Number: NCT07470346

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Severe Mental Disorder Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Severe Mental Illness Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Román Alberca Psychiatric Hospital

El Palmar, Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Alejando Vargas Rubio

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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