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Efficacy of a Dog Assisted Group Intervention in Elderly with Unwanted Loneliness

Efficacy of a Dog Assisted Group Intervention in Elderly People with Unwanted Loneliness: Project Paws with You

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06860412
Acronym
AAI
Enrollment
20
Registered
2025-03-06
Start date
2025-02-12
Completion date
2026-03-31
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Animal Assisted Therapy, Elderly (people Aged 65 or More), Loneliness

Keywords

Animal Assisted Therapy, Elderly, Loneliness, Social isolation, Primary Healthcare, Human-Animal Interactions

Brief 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. 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.

Interventions

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.

BEHAVIORALPsychoeducational Intervention as Usual

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.

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The principal statistician are blind to identifying participant information and group assignment.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline on UCLA (University of California at Los Angeles) scale at 9 weeks.This scale was administered at baseline and at week 9The 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.

Secondary

MeasureTime frameDescription
Change from baseline on Goldberg Anxiety and Depression Scale (GADS) at 9 weeks.This scale was administered at baseline and at week 9The 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.
Change from baseline on Emotional Well-Being Scale at 9 weeks.This scale was administered at baseline and at week 9The 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.
Change from baseline on Duke-UNC-11 Functional Social Support Questionnaire at 9 weeks.This scale was administered at baseline and at week 9The 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)

Other

MeasureTime frameDescription
Satisfaction questionnaire at the end of the intervention at week 9This questionnaire was administered at week 9Satisfaction will be evaluated through a self-administered questionnaire to analyze the participants' satisfaction with the methodology, organization and resources, and the usefulness of the intervention. It will be scored on a 10-point Likert scale, from totally disagree to totally agree.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026