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OpenTrials
Completed

NCT Number: NCT05089201

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.

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Key information

Conditions

Loneliness Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Number of participants enrolled

    Time frame: 2 years

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

  2. Attrition rate

    Time frame: 30 months

    Number of participants who do not complete the full study

Secondary outcomes

  1. Change in loneliness

    Time frame: Baseline to 6 months

    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).

  2. Change in depression

    Time frame: Baseline to 6 months

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

  3. Change in anxiety

    Time frame: Baseline to 6 months

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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Human Animal Bond Research Institute (HABRI)
  • Waltham Petcare Science Institute

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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