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

NCT06860412 | Active Not Recruiting DMC

• 1 other identifier: Loneliness 25/020-P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline on Goldberg Anxiety and Depression Scale (GADS) at 9 weeks.

  This scale was administered at baseline and at week 9

• Change from baseline on Emotional Well-Being Scale at 9 weeks.

  This scale was administered at baseline and at week 9

• Change from baseline on Duke-UNC-11 Functional Social Support Questionnaire at 9 weeks.

  This scale was administered at baseline and at week 9

Other Outcomes (1)

• Satisfaction questionnaire at the end of the intervention at week 9

  This questionnaire was administered at week 9

Study Arms (2)

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.

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.

Behavioral: Psychoeducational Intervention as Usual

Interventions

Animal Assisted Intervention 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.

Animal Assisted Intervention

Psychoeducational Intervention as Usual 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.

Psychoeducational Intervention as Usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Atenció Primària Bordeta-Magraners

Lleida, Lleida, 25001, Spain

Location

MeSH Terms

Conditions

Social Isolation; Human-Animal Interaction

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal statistician are blind to identifying participant information and group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 6, 2025
• Study Start: February 12, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)