LonelinessNCT05089201
A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations
A study testing Animal-assisted interaction in people with Loneliness and Depression, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Depression, Anxiety
- What is being tested?
- Animal-assisted interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Projected to be admitted to the hospital for the upcoming four days
- Speak English
- Able to provide consent.
Who cannot join
- Fear of, or allergy to, dogs
- Documented contact precautions
- Cognitive impairment that prevents consent or completion of measures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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:
- 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.
- Conditions
- Loneliness, Depression, Anxiety, Quality of Life
- Being tested
- Animal-assisted interaction, Conversational control
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted interactionBehavioural
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 controlBehavioural
A handler alone will visit participants without a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted interaction (AAI) | Experimental | Dogs and handlers will visit with patients for 20 minutes and discuss semi-scripted topics. Receives: Behavioral: Animal-assisted interaction |
| Conversational interaction | Active comparator | Handlers will have a 20 minute semi-scripted conversation with patients. Receives: Behavioral: Conversational control |
| Treatment as usual | No intervention | Patients will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled
The number of eligible patients who sigh consent forms and are randomized to a condition
Measured: 2 years
Attrition rate
Number of participants who do not complete the full study
Measured: 30 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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).
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start16 Nov 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Waltham Petcare Science Institute, Human Animal Bond Research Institute (HABRI)
- Responsible party
- Sponsor
- Investigators
- Nancy R. Gee, PhD, Principal investigator, Virginia Commonwealth UniversityLisa Townsend, PhD, Study director, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089201
- Sponsor's protocol ID
- HM20021567
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41450829Gee 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.
PubMed 39790554
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations
- ClinicalTrials.gov ID
- NCT05089201
- Acronym / sponsor ID
- HM20021567
- Conditions
- Loneliness, Depression, Anxiety, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Waltham Petcare Science Institute, Human Animal Bond Research Institute (HABRI)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted interaction (AAI) | Experimental | Behavioral: Animal-assisted interactionDogs and handlers will visit with patients for 20 minutes and discuss semi-scripted topics. |
| Conversational interaction | Active comparator | Behavioral: Conversational controlHandlers will have a 20 minute semi-scripted conversation with patients. |
| Treatment as usual | No intervention | –Patients will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Projected to be admitted to the hospital for the upcoming four days
- Speak English
- Able to provide consent.
Key exclusion criteria (3 listed)
- Fear of, or allergy to, dogs
- Documented contact precautions
- Cognitive impairment that prevents consent or completion of measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted interactionA 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 | Behavioural | Animal-assisted interaction (AAI) |
| Conversational controlA handler alone will visit participants without a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay | Behavioural | Conversational interaction |
Primary outcome
Number of participants enrolled
Time frame: 2 years
The number of eligible patients who sigh consent forms and are randomized to a condition
Attrition rate
Time frame: 30 months
Number of participants who do not complete the full study
3 secondary outcomes
Change in loneliness
Time frame: Baseline to 6 months
Change in depression
Time frame: Baseline to 6 months
Change in anxiety
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 41450829Gee 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.
- Derived from this study: PubMed 39790554Gee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy R. Gee, PhD principal investigator
Virginia Commonwealth University
Lisa Townsend, PhD study director
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted interaction in people with Loneliness and Depression, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089201, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.