An interventional study of Animal Assisted Intervention and Psychoeducational Intervention as Usual in Loneliness, Elderly (people Aged 65 or More) and Animal Assisted Therapy, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Active, not recruiting at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment
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.
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.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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
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 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.
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.
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.
Time frame: 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.
Time frame: 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.
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.
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)
Time frame: This scale was administered at baseline and at week 9
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.
Time frame: This questionnaire was administered at week 9
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina