CClinicalTrials.gg
CompletedNCT05089201Updated Apr 12, 2024

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

An interventional study of Animal-assisted interaction and Conversational control in Loneliness, Depression and Anxiety, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Loneliness
  • Depression
  • Anxiety
  • Quality of Life
03

In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Fear of, or allergy to, dogs
  • Documented contact precautions
  • Cognitive impairment that prevents consent or completion of measures.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Animal-assisted interaction (AAI)

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

    Behavioral: Animal-assisted interaction

  • Active comparator
    Conversational interaction

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

    Behavioral: Conversational control

  • No intervention
    Treatment as usual

    Patients will receive treatment as usual.

Interventions

  • BehavioralAnimal-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

  • BehavioralConversational control

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

06

What researchers measure

Primary outcomes

  1. Number of participants enrolled

    The number of eligible patients who sigh consent forms and are randomized to a condition

    Time frame: 2 years

  2. Attrition rate

    Number of participants who do not complete the full study

    Time frame: 30 months

Secondary outcomes

  1. 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).

    Time frame: Baseline to 6 months

  2. Change in depression

    Depressive symptomology will be measured with the 10-item Center for Epidemiological Studies Depression short form (CESD-10) scale.

    Time frame: Baseline to 6 months

  3. Change in anxiety

    Anxiety will be measured using the 20-item scale of the State-Trait Anxiety Inventory for Adults (STAI-AD).

    Time frame: Baseline to 6 months

07

Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05089201
Lead sponsor
Virginia Commonwealth University
Collaborators
Waltham Petcare Science Institute, Human Animal Bond Research Institute (HABRI)
Responsible party
Sponsor
First posted
Oct 22, 2021
Start date
Nov 16, 2021
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Last update
Apr 12, 2024

Study contacts

Nancy R. Gee, PhD
principal investigator · Virginia Commonwealth University
Lisa Townsend, PhD
study director · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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