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

NCT07379996 | Completed

• 1 other identifier: CEI.24-93.TFM-A.VargasRubio
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Mental Disorder; Severe Mental Illness

Keywords

Severe Mental Disorder; Hope; Music therapy; Social functioning; Quality of life; Severe mental illness; Mental health recovery; Recovery

Outcome Measures

Primary Outcomes (3)

• WHOQOL-BREF - Quality of Life Scale

  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.

  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)

• Beck Hopelessness Scale (BHS)

  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).

  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).

• Social Functioning Scale (SFS)

  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.

  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).

Secondary Outcomes (1)

• Satisfaction with the received intervention

  At the end of the intervention, in Week 20.

Study Arms (1)

Individuals with Severe Mental Disorder from an Assertive Community Treatment Team

EXPERIMENTAL

The study was conducted within a community-based service for individuals with Severe Mental Disorder, called the Assertive Community Treatment Team (ACT Team), located in the city of Cartagena, Spain. The study participants were active users currently receiving care from this service.

Behavioral: Passive music therapy in an individual format

Interventions

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.

Individuals with Severe Mental Disorder from an Assertive Community Treatment Team

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alejando Vargas Rubio: lead

Study Sites (1)

Mental Health Rehabilitation Unit of Cartagena

Cartagena, Murcia, 30203, Spain

Location

MeSH Terms

Conditions

Mental Disorders; Social Adjustment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

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: Pilot study with a quasi-experimental pre-test and post-test design

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: February 3, 2025
• Primary Completion: June 2, 2025
• Study Completion: June 19, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

ES (1)