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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Loneliness; Animal Assisted Therapy; Elderly (people Aged 65 or More)
• Intervention / Treatment: Behavioral: Animal Assisted Intervention; Behavioral: Psychoeducational Intervention as Usual

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25001
    • Centre Atenció Primària Bordeta-Magraners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Animal Assisted Intervention; 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.	Behavioral: Animal Assisted Intervention; 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.
Active Comparator: Psychoeducational Intervention as Usual; 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.	Behavioral: Psychoeducational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This scale was administered at baseline and at week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	This scale was administered at baseline and at week 9
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.	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.	This scale was administered at baseline and at week 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire at the end of the intervention at week 9	Satisfaction 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.	This questionnaire was administered at week 9

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Loneliness; Animal Assisted Therapy; Primary Healthcare; Social isolation; Human-Animal Interactions
• Other Study ID Numbers: Loneliness 25/020-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No