A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations

Not Applicable

Completed

• Conditions: Loneliness; Depression; Anxiety; Quality of Life
• Interventions: Behavioral: Animal-assisted interaction; Behavioral: Conversational control

• Registration Number: NCT05089201
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The purpose of this research study is to test whether an animal-assisted interaction (AAI) intervention is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services. Participants will be patients admitted for an inpatient stay at Virginia Commonwealth University Health who meet the study entry requirements.

Detailed Description

Participants will be randomly assigned (like the flip of a coin) to receive one of the following interventions:

1. Animal-assisted interaction (a dog-handler team will visit them in their hospital room)

2. Conversational interaction with just participants and the handler

3. Treatment as usual (the regular services patients are currently receiving in the hospital)

Participation in this study will last six months. This includes the three days on which participants will receive one of the interventions described above, plus completing some questionnaires online or by phone one month and six months after the baseline visit. These questionnaires will ask questions about pet ownership, relationship with pets participants have had, loneliness, depression, anxiety, health-related quality of life, significant life events in the past year, and social supports. Approximately 180 individuals will participate in this study.

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-22
• Study Start: 2021-11-16
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 18 years of age or older
• Projected to be admitted to the hospital for the upcoming four days
• Speak English
• Able to provide consent.

Exclusion Criteria

• Fear of, or allergy to, dogs
• Documented contact precautions
• Cognitive impairment that prevents consent or completion of measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Animal-assisted interaction (AAI)	Animal-assisted interaction	Dogs and handlers will visit with patients for 20 minutes and discuss semi-scripted topics.
Conversational interaction	Conversational control	Handlers will have a 20 minute semi-scripted conversation with patients.

Primary Outcome Measures

Name	Time	Method
Attrition rate	30 months	Number of participants who do not complete the full study
Number of participants enrolled	2 years	The number of eligible patients who sigh consent forms and are randomized to a condition

Secondary Outcome Measures

Name	Time	Method
Change in loneliness	Baseline to 6 months	Loneliness will be assessed using the 20-item Revised (Version 3) University of California, Los Angeles Loneliness Scale (Rev University of California, Los Angeles - Loneliness Scale).
Change in anxiety	Baseline to 6 months	Anxiety will be measured using the 20-item scale of the State-Trait Anxiety Inventory for Adults (STAI-AD).
Change in depression	Baseline to 6 months	Depressive symptomology will be measured with the 10-item Center for Epidemiological Studies Depression short form (CESD-10) scale.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States