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

NCT ID: NCT06860412

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2026-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Animal Assisted Intervention

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Psychoeducational Intervention as Usual

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Atenció Primària Bordeta-Magraners

Lleida, Lleida, Spain

Countries

Spain

Other Identifiers

Loneliness 25/020-P

Identifier Type: -

Identifier Source: org_study_id