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

Study Overview
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Brief Summary
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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
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Participants will be randomly assigned (like the flip of a coin) to receive one of the following interventions: Animal-assisted interaction (a dog-handler team will visit them in their hospital room) Conversational interaction with just participants and the handler 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.

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

Conditions
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Loneliness, Depression, Anxiety, Quality of Life

Intervention / Treatment
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* Behavioral: Animal-assisted interaction
* Behavioral: Conversational control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |