A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06382181
• Other study ID #: 2023- ENFPOD-2621979
• Secondary ID: Silvia Corchón A
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Loneliness
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• Music therapy for community-dwelling individuals with unwanted loneliness
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.
• Health education for community-dwelling individuals with unwanted loneliness
Twelve health education workshops were carried out. They included group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.
• Physical exercise for community-dwelling individuals with unwanted loneliness
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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia
Spain	Vanessa Ibáñez del Valle	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Jong Gierveld Loneliness Scale	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.	3 months
Secondary	Score on Goldberg Anxiety and Depression Scale	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.	3 months