LonelinessAAINCT06860412
Efficacy of a Dog Assisted Group Intervention in Elderly with Unwanted Loneliness
A study testing Animal Assisted Intervention and Psychoeducational Intervention as Usual in people with Loneliness and Elderly (people Aged 65 or More), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the efficacy of a dog-assisted group intervention in elderly people with unwanted loneliness; in terms of improving the perception of unwanted loneliness and emotional well-being. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Loneliness, Elderly (people Aged 65 or More), Animal Assisted Therapy
- What is being tested?
- Animal Assisted Intervention and Psychoeducational Intervention as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2025to Mar 2026
- 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
- People who are 65 years of age or older assigned to the Primary Health Care Center.
- With a diagnosis of "living alone" registered in the computerized clinical history.
- Present unwanted loneliness with a score higher than 3 on the Three-Item Loneliness Scale (TIL Scale). The TIL Scale consists of three questions: How often do you feel that you lack company?, How often do you feel excluded?, How often do you feel isolated? The response options consist of a three-level Likert scale: "almost never", "sometimes" and "often"; the results being from 3 to 9 points.
- Delivery of the information sheet and signature of the informed consent.
Who cannot join
- If in the initial interview they declared having allergy to dogs.
- Significant fear of dogs
- Meets research criteria for a diagnosis of dementia.
- Do not understand or speak Catalan or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Dog Assisted Group Intervention in Elderly People with Unwanted Loneliness: Project "Paws with You"
The purpose of this study is to evaluate the efficacy of a dog-assisted group intervention in elderly people with unwanted loneliness; in terms of improving the perception of unwanted loneliness and emotional well-being. To analyze whether differences are obtained in social support and to determine the satisfaction of the participants. Participants will be recruited from a Primary Health Care Center. These objectives will be accomplished through a randomized clinical trial, single blind, two-arm study of AAT for elderly people with unwanted loneliness.
Read the detailed description
Background: Unwanted loneliness negatively affects the physical and psychological health of older adults, as well as increasing the likelihood of engaging in behaviors harmful to health. This is an increasing reality and is considered a public health problem. Animal-Assisted Therapy (AAT) is a planned, structured, goal-oriented therapeutic intervention directed by health professionals.
Purposes: To evaluate the efficacy of AAT (with therapy dogs) in elderly people with unwanted loneliness. To assess whether there are differences in the scores obtained after the group intervention regarding the perception of unwanted loneliness and emotional well-being. To analyze whether differences are obtained in social support. To determine participants' satisfaction with the group intervention.
Methodology: A two-arm randomized controlled clinical trial (control group (CG) and experimental group (EG)) with a simple blind (evaluator). Participants will be recruited from a Primary Health Care Center: aged 65 or older, diagnosed as "living alone," and experiencing unwanted loneliness. Intervention: The EG will participate in 9 psycho-educational group sessions (once-a week, 90 minutes) with a therapy dog as a facilitator. In the CG, the same sessions will be conducted without the therapy dog. Assessment: UCLA Loneliness Scale, Goldberg Anxiety and Depression Scale, Emotional Well-Being Scale (e-CAP), Duke-UNC-11 Functional Social Support Questionnaire, and Satisfaction Questionnaire.
- Being tested
- Animal Assisted Intervention, Psychoeducational Intervention as Usual
- Keywords
- Animal Assisted Therapy, Elderly, Loneliness, Social isolation, Primary Healthcare, Human-Animal Interactions
- Medical subject headings
- Social Isolation, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted InterventionBehavioural
This is a multimodal group intervention program that simultaneously carries out health education activities, physical activities, emotional activities and social interactions through the integration of a psychoeducational intervention and animal-assisted therapy for elderly people with unwanted loneliness.
Psychoeducational Intervention as UsualBehavioural
This psychoeducational intervention is a multimodal group intervention program that simultaneously carries out health education activities, physical activities, emotional activities and social interactions for elderly people with unwanted loneliness.
| Study group | Role | What they receive |
|---|---|---|
| Animal Assisted Intervention | Experimental | Participants assigned to the experimental arm will receive active non-pharmacological treatment utilizing a Psychoeducational Intervention accompanied by live therapy dogs. The experimental group will carry out a total of 9 group sessions of one and a half hour duration, on a weekly basis for 9 consecutive weeks. The groups will be formed by 10 participants. Receives: Behavioral: Animal Assisted Intervention |
| Psychoeducational Intervention as Usual | Active comparator | Participants assigned to the active comparator arm will receive active non-pharmacological treatment utilizing a psychoeducational intervention as usual. The participants carry out a total of 9 group sessions of one and a half hour duration, on a weekly basis for 9 consecutive weeks. The groups will be formed by 10 participants. Receives: Behavioral: Psychoeducational Intervention as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on UCLA (University of California at Los Angeles) scale at 9 weeks.
The UCLA scale has proven to be a useful and sensitive instrument for measuring feelings of loneliness in the elderly. The scale consists of 10 questions scored between 1 and 4 points, allowing a minimum score of 10 and a maximum of 40.
- Scores <20 may indicate a severe degree of loneliness.
- Scores between 20-30 may indicate a moderate degree of loneliness.
Measured: This scale was administered at baseline and at week 9
Secondary outcomes (3)
Change from baseline on Goldberg Anxiety and Depression Scale (GADS) at 9 weeks.
The Goldberg anxiety and depression scale is an 18 item self-report symptom inventory with "yes" and "no" response options, with two subscales: one for anxiety (9 items) and one for depression (9 items). Higher scores mean a worse outcome.
Measured: This scale was administered at baseline and at week 9
Change from baseline on Emotional Well-Being Scale at 9 weeks.
The questionnaire consists of seven items measured on a Likert scale, with five response options (1 = never and 5 = always) on how the individual has felt in the last two weeks; with a score range from 5 to 35, higher scores mean a better outcome.
Measured: This scale was administered at baseline and at week 9
Change from baseline on Duke-UNC-11 Functional Social Support Questionnaire at 9 weeks.
The Duke-UNC-11 questionnaire assesses confidential social support (availability of people to communicate with) and affective social support (demonstrations of love, affection, and empathy). Likert scale with scores from 1 to 5. It consists of 11 items with a score range from 11 to 55 (a score <32 indicates low perceived social support)
Measured: This scale was administered at baseline and at week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start12 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860412
- Sponsor's protocol ID
- Loneliness 25/020-P
- Acronym
- AAI
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Dog Assisted Group Intervention in Elderly People with Unwanted Loneliness: Project "Paws with You"
- ClinicalTrials.gov ID
- NCT06860412
- Acronym / sponsor ID
- AAI / Loneliness 25/020-P
- Keywords
- Animal Assisted Therapy, Elderly, Loneliness, Social isolation, Primary Healthcare, Human-Animal Interactions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 Mar 2025 (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 purpose of this study is to evaluate the efficacy of a dog-assisted group intervention in elderly people with unwanted loneliness; in terms of improving the perception of unwanted loneliness and emotional well-being. To analyze whether differences are obtained in social support and to determine the satisfaction of the participants. Participants will be recruited from a Primary Health Care Center. These objectives will be accomplished through a randomized clinical trial, single blind, two-arm study of AAT for elderly people with unwanted loneliness.
Detailed description
Background: Unwanted loneliness negatively affects the physical and psychological health of older adults, as well as increasing the likelihood of engaging in behaviors harmful to health. This is an increasing reality and is considered a public health problem. Animal-Assisted Therapy (AAT) is a planned, structured, goal-oriented therapeutic intervention directed by health professionals.
Purposes: To evaluate the efficacy of AAT (with therapy dogs) in elderly people with unwanted loneliness. To assess whether there are differences in the scores obtained after the group intervention regarding the perception of unwanted loneliness and emotional well-being. To analyze whether differences are obtained in social support. To determine participants' satisfaction with the group intervention.
Methodology: A two-arm randomized controlled clinical trial (control group (CG) and experimental group (EG)) with a simple blind (evaluator). Participants will be recruited from a Primary Health Care Center: aged 65 or older, diagnosed as "living alone," and experiencing unwanted loneliness. Intervention: The EG will participate in 9 psycho-educational group sessions (once-a week, 90 minutes) with a therapy dog as a facilitator. In the CG, the same sessions will be conducted without the therapy dog. Assessment: UCLA Loneliness Scale, Goldberg Anxiety and Depression Scale, Emotional Well-Being Scale (e-CAP), Duke-UNC-11 Functional Social Support Questionnaire, and Satisfaction Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal Assisted Intervention | Experimental | Behavioral: Animal Assisted InterventionParticipants assigned to the experimental arm will receive active non-pharmacological treatment utilizing a Psychoeducational Intervention accompanied by live therapy dogs. The experimental group will carry out a total of 9 group sessions of one and a half hour duration, on a weekly basis for 9 consecutive weeks. The groups will be formed by 10 participants. |
| Psychoeducational Intervention as Usual | Active comparator | Behavioral: Psychoeducational Intervention as UsualParticipants assigned to the active comparator arm will receive active non-pharmacological treatment utilizing a psychoeducational intervention as usual. The participants carry out a total of 9 group sessions of one and a half hour duration, on a weekly basis for 9 consecutive weeks. The groups will be formed by 10 participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People who are 65 years of age or older assigned to the Primary Health Care Center.
- With a diagnosis of "living alone" registered in the computerized clinical history.
- Present unwanted loneliness with a score higher than 3 on the Three-Item Loneliness Scale (TIL Scale). The TIL Scale consists of three questions: How often do you feel that you lack company?, How often do you feel excluded?, How often do you feel isolated? The response options consist of a three-level Likert scale: "almost never", "sometimes" and "often"; the results being from 3 to 9 points.
- Delivery of the information sheet and signature of the informed consent.
Key exclusion criteria (4 listed)
- If in the initial interview they declared having allergy to dogs.
- Significant fear of dogs
- Meets research criteria for a diagnosis of dementia.
- Do not understand or speak Catalan or Spanish
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 |
|---|---|---|
| Animal Assisted InterventionThis is a multimodal group intervention program that simultaneously carries out health education activities, physical activities, emotional activities and social interactions through the integration of a psychoeducational intervention and animal-assisted therapy for elderly people with unwanted loneliness. | Behavioural | Animal Assisted Intervention |
| Psychoeducational Intervention as UsualThis psychoeducational intervention is a multimodal group intervention program that simultaneously carries out health education activities, physical activities, emotional activities and social interactions for elderly people with unwanted loneliness. | Behavioural | Psychoeducational Intervention as Usual |
Primary outcome
Change from baseline on UCLA (University of California at Los Angeles) scale at 9 weeks.
Time frame: This scale was administered at baseline and at week 9
The UCLA scale has proven to be a useful and sensitive instrument for measuring feelings of loneliness in the elderly. The scale consists of 10 questions scored between 1 and 4 points, allowing a minimum score of 10 and a maximum of 40. * Scores <20 may indicate a severe degree of loneliness. * Scores between 20-30 may indicate a moderate degree of loneliness.
3 secondary outcomes
Change from baseline on Goldberg Anxiety and Depression Scale (GADS) at 9 weeks.
Time frame: This scale was administered at baseline and at week 9
Change from baseline on Emotional Well-Being Scale at 9 weeks.
Time frame: This scale was administered at baseline and at week 9
Change from baseline on Duke-UNC-11 Functional Social Support Questionnaire at 9 weeks.
Time frame: This scale was administered at baseline and at week 9
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 12 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Intervention and Psychoeducational Intervention as Usual in people with Loneliness and Elderly (people Aged 65 or More), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 4 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. 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?
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?
Change from baseline on UCLA (University of California at Los Angeles) scale at 9 weeks. (time frame: This scale was administered at baseline and at week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.