A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

NCT06382181 | Completed DMC

• 3 other identifiers: 2023- ENFPOD-2621979Silvia Corchón ArrecheOmar Cauli
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Loneliness; Mental Health Disorder

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score on Goldberg Anxiety and Depression Scale

  3 months

Study Arms (3)

Music Therapy

EXPERIMENTAL

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

Health education

EXPERIMENTAL

Health education workshops

Behavioral: Health education for community-dwelling individuals with unwanted loneliness

Physical exercise

EXPERIMENTAL

Physical exercise adapted to the physical conditions of each participant

Behavioral: Physical exercise for community-dwelling individuals with unwanted loneliness

Interventions

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.

Also known as: Music therapy

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.

Also known as: Health education

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.

Also known as: Physical exercise

Physical exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \+ Severe mental disorder or dementia.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

University of Valencia

Valencia, 46010, Spain

Location

Vanessa Ibáñez del Valle

Valencia, 46010, Spain

Location

Related Publications (1)

• Mafla-Espana MA, Corchon S, Jimeno-de Pedro P, Ibanez-Del Valle V, Cauli O. Social and Mental Health Factors Involved in the Severity of Loneliness in Older Individuals in a Spanish Rural Area. Nurs Rep. 2024 Nov 29;14(4):3737-3753. doi: 10.3390/nursrep14040273.

  PMID: 39728634 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Music Therapy; Exercise

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vanessa Ibáñez del Valle, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were assigned to three groups in parallel for the duration of the study

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 24, 2024
• Study Start: April 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 31, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)