A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

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

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).

Study Overview

• Status: Completed
• Conditions: Mental Health Disorder; Loneliness
• Intervention / Treatment: Behavioral: Music therapy for community-dwelling individuals with unwanted loneliness; Behavioral: Health education for community-dwelling individuals with unwanted loneliness; Behavioral: Physical exercise for community-dwelling individuals with unwanted loneliness

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia
  • Valencia, Spain, 46010
    • Vanessa Ibáñez del Valle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Therapy; Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged.	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.; Other Names: Music therapy
Experimental: Health education; Health education workshops	Behavioral: 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.; Other Names: Health education
Experimental: Physical exercise; Physical exercise adapted to the physical conditions of each participant	Behavioral: 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.; Other Names: Physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Vanessa Ibáñez del Valle, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Music Therapy
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2023- ENFPOD-2621979; Silvia Corchón Arreche (Other Identifier: University of Valencia); Omar Cauli (Other Identifier: University of Valencia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results are expected to be shared through scientific articles in peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No