LonelinessNCT06382181
A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness
A study testing Music therapy for community-dwelling individuals with unwanted loneliness, Health education for community-dwelling individuals with unwanted loneliness and Physical exercise for community-dwelling individuals with unwanted loneliness in people with Loneliness and Mental Health Disorder, run by University of Valencia at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Loneliness, Mental Health Disorder
- What is being tested?
- Music therapy for community-dwelling individuals with unwanted loneliness, Health education for community-dwelling individuals with unwanted loneliness and Physical exercise for community-dwelling individuals with unwanted loneliness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- + Severe mental disorder or dementia.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Valencia
Valencia, Valencia, 46010
Vanessa Ibáñez del Valle
Valencia, Valencia, 46010
About this study
Official title: 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).
Read the 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.
- Conditions
- Loneliness, Mental Health Disorder
- Being tested
- Music therapy for community-dwelling individuals with unwanted loneliness, Health education for community-dwelling individuals with unwanted loneliness, Physical exercise for community-dwelling individuals with unwanted loneliness
- Keywords
- Music Therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy for community-dwelling individuals with unwanted lonelinessBehavioural
Also called Music therapy
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 lonelinessBehavioural
Also called Health education
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 lonelinessBehavioural
Also called Physical exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Centre 1. Music Therapy, Health education workshops and Physical exercise workshops | Experimental | Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged. Health education workshops. Physical exercise adapted to the physical conditions of each participant. Receives: 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 |
| Centre 2. Music Therapy, Health education workshops and Physical exercise workshops | Experimental | Arm Description: Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged. Health education workshops. Physical exercise adapted to the physical conditions of each participant. Receives: 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 |
| Centre 3. Music Therapy, Health education workshops and Physical exercise workshops | Experimental | Arm Description: Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged. Health education workshops. Physical exercise adapted to the physical conditions of each participant. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to three groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María-Vanesa Ibáñez-del-Valle, University of Valencia
- Investigators
- Vanessa Ibáñez del Valle, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382181
- Sponsor's protocol ID
- 2023- ENFPOD-2621979
- Other IDs
- Silvia Corchón Arreche, Omar Cauli
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results are expected to be shared through scientific articles in peer-reviewed journals.
Publications
Zaharia G, Valle VI, Corchon S, Cauli O. Association between salivary oxytocin concentration and social loneliness in older adults: Findings from an uncontrolled pre-post multimodal intervention study. Psychoneuroendocrinology. 2026 Oct;192:107968. doi: 10.1016/j.psyneuen.2026.107968. Epub 2026 Jul 20.
PubMed 42475809Mafla-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.
PubMed 39728634
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness: Music Therapy, Health Education, and Physical Exercise
- ClinicalTrials.gov ID
- NCT06382181
- Acronym / sponsor ID
- 2023- ENFPOD-2621979
- Conditions
- Loneliness, Mental Health Disorder
- Keywords
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were assigned to three groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Centre 1. Music Therapy, Health education workshops and Physical exercise workshops | Experimental | 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 lonelinessThrough listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged. Health education workshops. Physical exercise adapted to the physical conditions of each participant. |
| Centre 2. Music Therapy, Health education workshops and Physical exercise workshops | Experimental | 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 lonelinessArm Description: Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged. Health education workshops. Physical exercise adapted to the physical conditions of each participant. |
| Centre 3. Music Therapy, Health education workshops and Physical exercise workshops | Experimental | 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 lonelinessArm Description: Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged. Health education workshops. Physical exercise adapted to the physical conditions of each participant. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- + Severe mental disorder or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy for community-dwelling individuals with unwanted lonelinessAlso: Music therapyMusic 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. | Behavioural | Centre 1. Music Therapy, Health education workshops and Physical exercise workshops, Centre 2. Music Therapy, Health education workshops and Physical exercise workshops, Centre 3. Music Therapy, Health education workshops and Physical exercise workshops |
| Health education for community-dwelling individuals with unwanted lonelinessAlso: Health educationTwelve health education workshops were carried out. They included group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others. | Behavioural | Centre 1. Music Therapy, Health education workshops and Physical exercise workshops, Centre 2. Music Therapy, Health education workshops and Physical exercise workshops, Centre 3. Music Therapy, Health education workshops and Physical exercise workshops |
| Physical exercise for community-dwelling individuals with unwanted lonelinessAlso: Physical exerciseThis intervention was implemented with 2 group sessions each week for 13 weeks. It included physical exercise adapted to the physical conditions of each participant. | Behavioural | Centre 1. Music Therapy, Health education workshops and Physical exercise workshops, Centre 2. Music Therapy, Health education workshops and Physical exercise workshops, Centre 3. Music Therapy, Health education workshops and Physical exercise workshops |
Primary outcome
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.
1 secondary outcome
Score on Goldberg Anxiety and Depression Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 42475809Zaharia G, Valle VI, Corchon S, Cauli O. Association between salivary oxytocin concentration and social loneliness in older adults: Findings from an uncontrolled pre-post multimodal intervention study. Psychoneuroendocrinology. 2026 Oct;192:107968. doi: 10.1016/j.psyneuen.2026.107968. Epub 2026 Jul 20.
- Derived from this study: PubMed 39728634Mafla-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.
- Individual participant dataSharing planned: No. Results are expected to be shared through scientific articles in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Ibáñez del Valle, PhD principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy for community-dwelling individuals with unwanted loneliness, Health education for community-dwelling individuals with unwanted loneliness and Physical exercise for community-dwelling individuals with unwanted loneliness in people with Loneliness and Mental Health Disorder, run by University of Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Jong Gierveld Loneliness Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382181, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.