Alzheimer Disease (AD)NCT07639645
Intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer
A study testing Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer in people with Alzheimer Disease (AD) and Unwanted Loneliness, run by University of Valencia at 1 site 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 65 years and older
- Conditions the study is for
- Alzheimer Disease (AD), Unwanted Loneliness, Family Caregivers
- What is being tested?
- Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Family caregivers of people with Alzheimer's disease (AD).
- Primary family caregivers who live with the person with AD.
- The person with AD must be enrolled in one of the adult day care centers where the study is conducted.
- Ability to communicate in Spanish and/or Valencian.
Who cannot join
- Presence of moderate or severe cognitive impairment, mental disorder, significant sensory impairment, disabling chronic illness, or any medical condition that contraindicates participation in any of the study activities.
- Family caregivers of institutionalized individuals.
- Family caregivers of people with AD who have died.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease
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 and improve the living with process of family caregivers of people with Alzheimer disease through multiple interventions (music therapy, health education)
Read the detailed description
This project proposes a multimodal and interdisciplinary intervention aimed at alleviating or reducing unwanted loneliness and improving the living with process of family caregivers of individuals with Alzheimer's disease (AD). In doing so, it seeks to enhance their health and overall quality of life. The intervention will include activities such as health education, physical activity and music therapy.
The interdisciplinary team will also incorporate citizen participation, specifically through the involvement of an individual who has previously been a family caregiver of a person with AD. There is a growing body of evidence indicating that citizen participation in healthcare is highly advisable, as it is expected to improve the quality and relevance of outcomes.
This is a prospective, longitudinal, analytical, and experimental study.
The proposed study will involve different groups and the program will last for a total of 12 weeks. The program will include the following activities:
Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.
Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, Alzheimer disease, 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
- Being tested
- Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer
- Keywords
- unwanted loneliness, living with process, alzheimer disease, family caregiver, multicomponent intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With AlzheimerBehavioural
The multimodal intervention will include these activities:
- Health education workshops
- Music therapy sessions
- Physical exercise adapted to the physical conditions of each participant.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The multimodal interventions includes:
1. Behavioral: Health education for family caregivers of patients with Alzheimer disease with unwanted loneliness Twelve health education workshops will be carried out. These include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.
2. Behavioral: Music therapy for community-dwelling individuals with unwanted loneliness Description: Music therapy workshops will implemented. The enjoyment and expression of feelings will encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. One session per week. Total 12 sessions
3. Behavioral: Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions. Receives: Behavioral: Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer |
| No intervention group | No intervention | This group will receive the ussual care in the day centers for familiar caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Jong Gierveld Lonelinss Scale
Loneliness Scale Social isolation will be 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: From the beginning of the enrollement until the end of the intervention at 12 weeks
Living with chronic conditions from the family perspective
Living with LTCs scale from the perspective of the family caregiver (EC- PC- Fam). This is an instrument adapted from the original EC- PC.29-31 The adaptation process of the instrument and prior pilot study have been previously described in detail.23 The validated version has 31 items and 5 domains: (1) acceptance, (2) coping, (3) self- management, (4) integration and (5) adaptation. All the items follow a Likert scale of 5 points answer system, from never or none (0) to always and much (4), except for the items from the acceptance domain, which must be inverted to obtain results such as never or none (4) or always or much (0). The scores range from 0 to 155, with a higher score indicating more positive living with LTCs.
Measured: From the enrollment to the end of the intervention at 12 weeks
Secondary outcomes (3)
Score in Goldberg Anxiety and Depression Scale.
The symptoms of anxiety and depression will be 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: From enrollement until the end of the intervention ar 12 weeks
The score in the EuroQQL-5
The EuroQOL- 5 Dimensions 5- Level version (EQ- 5D- 5L) is an instrument designed to generically measure HRQOL, which can be used by both a healthy population and an individual with pathologies. The instrument developed by the EUROQOL group32 has been validated in many countries, including Spain.33 34 Different versions can be found, and in the present study, the EQ- 5D- 5L was selected due to the increase in the specificity of the responses as compared with the EQ- 5D- 3L. It is a self- administered instrument in which individuals assess their own health, first in a descriptive manner for each of the dimensions (mobility, personal care, everyday activities, pain/ discomfort and anxiety/depression), with five levels, from 0 to 5, and then with a more general Visual Analogical Scale. For the Spanish context, the psycho metric properties of the EQ- 5D- 5L scale were analysed in patients35 with the results indicating a reliability of 0.86.
Measured: From enrollement until the end of the intervention at 12 weeks
Score in Zarit Test for caregiver burden
Zarit test: This scale is included to verify the external validity (divergent validity) of the EC- PC- Fam. This scale, originally named Caregiver Burden Interview, is designed to assess the burden of caregivers of indi viduals with dementia, from the general theory of the items39. It has 22 items that evaluate the negative repercussions on specific areas of daily life associated with caregiving: physical health, psychological health, social activities and economic resources. As opposed to the original, the version validated in Spain40 includes a 5- point Likert scale, for a total score that ranges from 22 to 110. In this study, different cut- off points were proposed: from 22 to 46, without burden; from 47 to 55, with burden and from 56 to 110, intense burden. The scale obtained an internal consistency of 0.91 and test-retest reliability of 0.96.
Measured: From enrollement until the end of the intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease (AD)Studies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- The Faculty of Nursing and Podiatry, University of Valencia.
- Responsible party
- Principal investigator, Silvia Corchón Arreche, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639645
- Sponsor's protocol ID
- 2024-ENFPOD-3741812
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marin-Maicas P, Portillo MC, Corchon S, Ambrosio L. Methodological Proposal for the Adaptation of the Living with Long-Term Conditions Scale to the Family Caregiver. Nurs Rep. 2024 Feb 27;14(1):532-544. doi: 10.3390/nursrep14010041.
PubMed 38535713Mafla-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 39728634Marin-Maicas P, Ambrosio L, Corchon S, Gonzalez-Moreno J, Portillo MC. Living with long-term conditions: validation of a new instrument for family caregivers in a Spanish-speaking population. BMJ Open. 2024 Sep 20;14(9):e088773. doi: 10.1136/bmjopen-2024-088773.
PubMed 39306353Sanchez-Martinez V, Cauli O, Corchon S. Long-Term Caregiving Impact and Self-Care Strategies in Family Caregivers of People with Neuropsychiatric Disorders: A Mixed-Method Study. Diseases. 2024 Nov 14;12(11):292. doi: 10.3390/diseases12110292.
PubMed 39589966Marin-Maicas P, Corchon S, Ambrosio L, Portillo MC. Living with Long Term Conditions from the Perspective of Family Caregivers. A Scoping Review and Narrative Synthesis. Int J Environ Res Public Health. 2021 Jul 8;18(14):7294. doi: 10.3390/ijerph18147294.
PubMed 34299745Ibanez-Del Valle V, Corchon S, Zaharia G, Cauli O. Social and Emotional Loneliness in Older Community Dwelling-Individuals: The Role of Socio-Demographics. Int J Environ Res Public Health. 2022 Dec 10;19(24):16622. doi: 10.3390/ijerph192416622.
PubMed 36554512Zaharia G, Ibanez-Del Valle V, Cauli O, Corchon S. The Long-Lasting Effect of Multidisciplinary Interventions for Emotional and Social Loneliness in Older Community-Dwelling Individuals: A Systematic Review. Nurs Rep. 2024 Dec 6;14(4):3847-3863. doi: 10.3390/nursrep14040281.
PubMed 39728642
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07639645
- Acronym / sponsor ID
- 2024-ENFPOD-3741812
- Keywords
- unwanted loneliness, living with process, alzheimer disease, family caregiver, multicomponent intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- The Faculty of Nursing and Podiatry, University of Valencia.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (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 and improve the living with process of family caregivers of people with Alzheimer disease through multiple interventions (music therapy, health education)
Detailed description
This project proposes a multimodal and interdisciplinary intervention aimed at alleviating or reducing unwanted loneliness and improving the living with process of family caregivers of individuals with Alzheimer's disease (AD). In doing so, it seeks to enhance their health and overall quality of life. The intervention will include activities such as health education, physical activity and music therapy.
The interdisciplinary team will also incorporate citizen participation, specifically through the involvement of an individual who has previously been a family caregiver of a person with AD. There is a growing body of evidence indicating that citizen participation in healthcare is highly advisable, as it is expected to improve the quality and relevance of outcomes.
This is a prospective, longitudinal, analytical, and experimental study.
The proposed study will involve different groups and the program will last for a total of 12 weeks. The program will include the following activities:
Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.
Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, Alzheimer disease, 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With AlzheimerThe multimodal interventions includes: 1. Behavioral: Health education for family caregivers of patients with Alzheimer disease with unwanted loneliness Twelve health education workshops will be carried out. These include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others. 2. Behavioral: Music therapy for community-dwelling individuals with unwanted loneliness Description: Music therapy workshops will implemented. The enjoyment and expression of feelings will encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. One session per week. Total 12 sessions 3. Behavioral: Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions. |
| No intervention group | No intervention | –This group will receive the ussual care in the day centers for familiar caregiver |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Family caregivers of people with Alzheimer's disease (AD).
- Primary family caregivers who live with the person with AD.
- The person with AD must be enrolled in one of the adult day care centers where the study is conducted.
- Ability to communicate in Spanish and/or Valencian.
Key exclusion criteria (3 listed)
- Presence of moderate or severe cognitive impairment, mental disorder, significant sensory impairment, disabling chronic illness, or any medical condition that contraindicates participation in any of the study activities.
- Family caregivers of institutionalized individuals.
- Family caregivers of people with AD who have died.
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 |
|---|---|---|
| Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With AlzheimerThe multimodal intervention will include these activities: 1. Health education workshops 2. Music therapy sessions 3. Physical exercise adapted to the physical conditions of each participant. | Behavioural | Experimental group |
Primary outcome
Score on the Jong Gierveld Lonelinss Scale
Time frame: From the beginning of the enrollement until the end of the intervention at 12 weeks
Loneliness Scale Social isolation will be 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.
Living with chronic conditions from the family perspective
Time frame: From the enrollment to the end of the intervention at 12 weeks
Living with LTCs scale from the perspective of the family caregiver (EC- PC- Fam). This is an instrument adapted from the original EC- PC.29-31 The adaptation process of the instrument and prior pilot study have been previously described in detail.23 The validated version has 31 items and 5 domains: (1) acceptance, (2) coping, (3) self- management, (4) integration and (5) adaptation. All the items follow a Likert scale of 5 points answer system, from never or none (0) to always and much (4), except for the items from the acceptance domain, which must be inverted to obtain results such as never or none (4) or always or much (0). The scores range from 0 to 155, with a higher score indicating more positive living with LTCs.
3 secondary outcomes
Score in Goldberg Anxiety and Depression Scale.
Time frame: From enrollement until the end of the intervention ar 12 weeks
The score in the EuroQQL-5
Time frame: From enrollement until the end of the intervention at 12 weeks
Score in Zarit Test for caregiver burden
Time frame: From enrollement until the end of the intervention at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 38535713Marin-Maicas P, Portillo MC, Corchon S, Ambrosio L. Methodological Proposal for the Adaptation of the Living with Long-Term Conditions Scale to the Family Caregiver. Nurs Rep. 2024 Feb 27;14(1):532-544. doi: 10.3390/nursrep14010041.
- Background: 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.
- Background: PubMed 39306353Marin-Maicas P, Ambrosio L, Corchon S, Gonzalez-Moreno J, Portillo MC. Living with long-term conditions: validation of a new instrument for family caregivers in a Spanish-speaking population. BMJ Open. 2024 Sep 20;14(9):e088773. doi: 10.1136/bmjopen-2024-088773.
- Background: PubMed 39589966Sanchez-Martinez V, Cauli O, Corchon S. Long-Term Caregiving Impact and Self-Care Strategies in Family Caregivers of People with Neuropsychiatric Disorders: A Mixed-Method Study. Diseases. 2024 Nov 14;12(11):292. doi: 10.3390/diseases12110292.
- Background: PubMed 34299745Marin-Maicas P, Corchon S, Ambrosio L, Portillo MC. Living with Long Term Conditions from the Perspective of Family Caregivers. A Scoping Review and Narrative Synthesis. Int J Environ Res Public Health. 2021 Jul 8;18(14):7294. doi: 10.3390/ijerph18147294.
- Background: PubMed 36554512Ibanez-Del Valle V, Corchon S, Zaharia G, Cauli O. Social and Emotional Loneliness in Older Community Dwelling-Individuals: The Role of Socio-Demographics. Int J Environ Res Public Health. 2022 Dec 10;19(24):16622. doi: 10.3390/ijerph192416622.
- Background: PubMed 39728642Zaharia G, Ibanez-Del Valle V, Cauli O, Corchon S. The Long-Lasting Effect of Multidisciplinary Interventions for Emotional and Social Loneliness in Older Community-Dwelling Individuals: A Systematic Review. Nurs Rep. 2024 Dec 6;14(4):3847-3863. doi: 10.3390/nursrep14040281.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer in people with Alzheimer Disease (AD) and Unwanted Loneliness, run by University of Valencia at 1 site 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Corchón, PhD (0034 963864182, Silvia.Corchon@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Jong Gierveld Lonelinss Scale (time frame: From the beginning of the enrollement until the end of the intervention at 12 weeks). The study lists 2 primary outcomes in all. 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 NCT07639645, which also lists 7 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 15 Jun 2026.