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

NCT05089201 | Completed

• 1 other identifier: HM20021567
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Depression; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in loneliness

  Baseline to 6 months

• Change in depression

  Baseline to 6 months

• Change in anxiety

  Baseline to 6 months

Study Arms (3)

Animal-assisted interaction (AAI)

EXPERIMENTAL

Dogs and handlers will visit with patients for 20 minutes and discuss semi-scripted topics.

Behavioral: Animal-assisted interaction

Conversational interaction

ACTIVE COMPARATOR

Handlers will have a 20 minute semi-scripted conversation with patients.

Behavioral: Conversational control

Treatment as usual

NO INTERVENTION

Patients will receive treatment as usual.

Interventions

Animal-assisted interaction BEHAVIORAL

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

Animal-assisted interaction (AAI)

Conversational control BEHAVIORAL

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

Conversational interaction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Waltham Petcare Science Institute: collaborator
• Human Animal Bond Research Institute (HABRI): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• Gee NR, Townsend L, Friedmann E, Barker SB, Thakre TP, Mueller MK. A pilot randomized controlled trial to examine the impact of a therapy dog intervention on loneliness in adult patients hospitalized in a psychiatric unit. Front Psychiatry. 2025 Dec 10;16:1582767. doi: 10.3389/fpsyt.2025.1582767. eCollection 2025.

  PMID: 41450829 DERIVED

• Gee NR, Townsend L, Friedmann E, Barker SB, Mueller MK. A Pilot Randomized Controlled Trial to Examine the Impact of a Therapy Dog Intervention on Loneliness in Hospitalized Older Adults. Innov Aging. 2024 Sep 16;8(11):igae085. doi: 10.1093/geroni/igae085. eCollection 2024.

  PMID: 39790554 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Nancy R. Gee, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Lisa Townsend, PhD

  Virginia Commonwealth University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 22, 2021
• Study Start: November 16, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)