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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Anxiety; Loneliness
• Intervention / Treatment: Behavioral: Animal-assisted interaction; Behavioral: Conversational control

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Animal-assisted interaction (AAI); Dogs and handlers will visit with patients for 20 minutes and discuss semi-scripted topics.	Behavioral: Animal-assisted interaction; A dog-handler team or a handler alone will visit participants with a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay
Active Comparator: Conversational interaction; Handlers will have a 20 minute semi-scripted conversation with patients.	Behavioral: Conversational control; A handler alone will visit participants without a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay
No Intervention: Treatment as usual; Patients will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in loneliness	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).	Baseline to 6 months
Change in depression	Depressive symptomology will be measured with the 10-item Center for Epidemiological Studies Depression short form (CESD-10) scale.	Baseline to 6 months
Change in anxiety	Anxiety will be measured using the 20-item scale of the State-Trait Anxiety Inventory for Adults (STAI-AD).	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Human Animal Bond Research Institute (HABRI); Waltham Petcare Science Institute
• Investigators: Principal Investigator: Nancy R. Gee, PhD, Virginia Commonwealth University; Study Director: Lisa Townsend, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HM20021567

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