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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089201
• Other study ID #: HM20021567
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Loneliness
• Quality of Life

Intervention

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
• Conversational control
A handler alone will visit participants without a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Human Animal Bond Research Institute (HABRI), Waltham Petcare Science Institute

Country where clinical trial is conducted

United States, 

Outcome

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