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Completed

NCT Number: NCT07379996

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

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.

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Key information

Conditions

Severe Mental Disorder Behavior Mental Disorders Severe Mental Illness Social Adjustment Social Behavior

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Rehabilitation Unit of Cartagena

Cartagena, Murcia, 30203, Spain

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Passive music therapy in an individual format

Behavioral

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.

Primary outcomes

  1. WHOQOL-BREF - Quality of Life Scale

    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)

    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.

  2. Beck Hopelessness Scale (BHS)

    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).

    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).

  3. Social Functioning Scale (SFS)

    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).

    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.

Secondary outcomes

  1. Satisfaction with the received intervention

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

    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).

Sponsors and collaborators

Lead sponsor

Alejando Vargas Rubio

Other

Registry information

Official study title

"Music Therapy in the Recovery Process of Individuals With Severe Mental Disorder in the Community Setting: A Pilot Study."

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 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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