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Completed

NCT Number: NCT06382181

A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise).

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Key information

Conditions

Loneliness Mental Disorders Mental Health Disorder

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia, Valencia, Spain

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About this study

The proposed study will involve 4 group sessions each week for a total of 13 weeks. The program will include the following activities:

Physical exercise adapted to the physical conditions of each participant. Total of 26 sessions (2 per week).

Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.

Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 60 years of age with unwanted loneliness
  • Must live in the city of Valencia
  • Must speak Spanish or Valencian (or have sufficient knowledge to be able to answer the questions in the study).

Exclusion criteria

+ Severe mental disorder or dementia.

Treatment and study plan

Music therapy for community-dwelling individuals with unwanted loneliness

Behavioral

Music therapy workshops were implemented. The enjoyment and expression of feelings were encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. There was one session per week. Total 12 sessions.

Other names: Music therapy

Health education for community-dwelling individuals with unwanted loneliness

Behavioral

Twelve health education workshops were carried out. They included group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.

Other names: Health education

Physical exercise for community-dwelling individuals with unwanted loneliness

Behavioral

This intervention was implemented with 2 group sessions each week for 13 weeks. It included physical exercise adapted to the physical conditions of each participant.

Other names: Physical exercise

Primary outcomes

  1. Score on the Jong Gierveld Loneliness Scale

    Time frame: 3 months

    Social isolation was measured with the Jong Gierveld Loneliness Scale.

    The final score is the total score for the 11 items, with the lowest possible score being 0 (no loneliness) and the highest being 11 (severe loneliness). Three categories have been proposed based on the score: a score of 0-2 points = no loneliness; a score of 3-8 points = moderate loneliness; and a score of 9-11 points = severe loneliness.

Secondary outcomes

  1. Score on Goldberg Anxiety and Depression Scale

    Time frame: 3 months

    The symptoms of anxiety and depression were measured with the Goldberg Anxiety and Depression Scale.

    This is a questionnaire that discriminates between the diagnosis of anxiety and depression and measures their retrospective intensities. It consists of two subscales: one for anxiety and one for depression. Each subscale is composed of 9 dichotomous response items (YES or NO) to determine whether the subject has had any of the indicated symptoms in the last two weeks. The cut-off points are 4 or more items or affirmative responses for the anxiety scale and 2 or more for the depression scale. The higher the score, the greater the severity of the problem, with a maximum possible score of 9 points for each subscale.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness: Music Therapy, Health Education, and Physical Exercise

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2024
Registry last updated
Jun 10, 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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