AnxietyNCT05326074
The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics
A study testing Animal assisted therapy cohort in people with Anxiety and Depression, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will examine whether a session of animal-assisted therapy reduces anxiety levels and improves long-term clinical outcomes of outpatient psychiatric patients in regard to their Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ-9 - Depression assessment), Three Item Loneliness scale… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Psychiatric or Mood Diseases or Conditions
- What is being tested?
- Animal assisted therapy cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2022to 11 Aug 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient psychiatric patients of Dr. Matt Kern who meet the criteria to be diagnosed with Major Depressive Disorder and/or Generalized Anxiety Disorder via Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder (GAD-7)
Who cannot join
- Prior history of animal related trauma
- Participants that require psychiatric hospitalization during the experiment will have their information excluded from analysis
- Participants who have changes made to any Hypertension / Blood Pressure medications during the experiment will have their Blood Pressure measurements removed from final analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
This study will examine whether a session of animal-assisted therapy reduces anxiety levels and improves long-term clinical outcomes of outpatient psychiatric patients in regard to their Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ-9 - Depression assessment), Three Item Loneliness scale (TIL), and Mean Arterial Blood Pressure.
Read the detailed description
Previous research regarding the value and benefits of Animal-Assisted Therapy (AAT) has often been focused on outcomes within In-Patient settings. One project showed that AATs may offer a decrease in agitated behaviors and an increase in social interactions in people with dementia. Prior research shows a reduction in anxiety when interacting with dogs. These reductions were seen in acutely schizophrenic patients, and General In-patient psychiatric patients. However, prior research has often relied on more obscure assessments that do not offer the validity and reliability seen with the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder scale (GAD-7).
Physiological responses have also been measured and show a reduction in blood pressure, norepinephrine, and epinephrine levels within hospitalized patients interacting with AATs. Quality of life and happiness have been shown to improve with the presence of animals. Loneliness has been shown to decrease amongst older adults interacting with AATs once per week. No difference was seen between people interacting with a dog 3 times per week versus once per week, which lends support to the value of a research project where patients may only interact with an AAT once per week.
Other publications regarding AATs focused on the theoretical value and discuss how hypothetically the AATs may be beneficial to patients and their perceived loneliness, stress, anxiety, interactions with others, and depression. These projects offer strong suggestions on future research projects regarding the value of AAT.
The prior research is encouraging to the idea that AATs may be beneficial in out-patient settings to Psychiatrists working with depression and anxiety. Given these prior publications, a desire for further evidence and a project validated by commonly used Psychiatry assessments is proposed here.
- Being tested
- Animal assisted therapy cohort
- Keywords
- Animal Assisted Therapy, Loneliness, Depression, Anxiety
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal assisted therapy cohortOther
A therapy dog will be present in the room during the routine outpatient psychiatric visit.
| Study group | Role | What they receive |
|---|---|---|
| Animal assisted therapy cohort | Experimental | This arm will be the group that is randomized to receiving animal assisted therapy during outpatient office visits. Receives: Other: Animal assisted therapy cohort |
| Control therapy cohort | No intervention | This arm will be the group that will receive the standard outpatient psychiatric treatment without animal therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Anxiety Disorder-7 (GAD-7) scores
The GAD-7 scores will be collected during the duration of the study and then analyzed upon completion to determine if any significant differences are observed between study arms - a score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7
Measured: Month 6
Patient Health Questionnaire-9 (PHQ-9) scores
The PHQ-9 scores will be collected during the duration of the study and then analyzed upon completion to determine if any significant differences are observed between study arms - score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression
Measured: Month 6
Three-Item Loneliness Scale (TIL) scores
The TIL scores will be collected during the duration of the study and then analyzed upon completion to determine if any significant differences are observed between study arms - Each question is rated on a 3-point scale: 1 = Hardly Ever; 2 = Some of the Time; 3 = Often. All items are summed to give a total score
Measured: Month 6
Secondary outcomes (1)
Mean Arterial Blood Pressure
Blood Pressure measurements will be taken before and after outpatient visits for all study participants and then compared upon completion of the study
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start8 Jul 2022
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Why it stopped: IRB Concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Kern, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326074
- Sponsor's protocol ID
- IRB00080233
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics
- ClinicalTrials.gov ID
- NCT05326074
- Acronym / sponsor ID
- IRB00080233
- Keywords
- Animal Assisted Therapy, Loneliness, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB Concerns
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 13 Apr 2022 (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.
This study will examine whether a session of animal-assisted therapy reduces anxiety levels and improves long-term clinical outcomes of outpatient psychiatric patients in regard to their Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ-9 - Depression assessment), Three Item Loneliness scale (TIL), and Mean Arterial Blood Pressure.
Detailed description
Previous research regarding the value and benefits of Animal-Assisted Therapy (AAT) has often been focused on outcomes within In-Patient settings. One project showed that AATs may offer a decrease in agitated behaviors and an increase in social interactions in people with dementia. Prior research shows a reduction in anxiety when interacting with dogs. These reductions were seen in acutely schizophrenic patients, and General In-patient psychiatric patients. However, prior research has often relied on more obscure assessments that do not offer the validity and reliability seen with the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder scale (GAD-7).
Physiological responses have also been measured and show a reduction in blood pressure, norepinephrine, and epinephrine levels within hospitalized patients interacting with AATs. Quality of life and happiness have been shown to improve with the presence of animals. Loneliness has been shown to decrease amongst older adults interacting with AATs once per week. No difference was seen between people interacting with a dog 3 times per week versus once per week, which lends support to the value of a research project where patients may only interact with an AAT once per week.
Other publications regarding AATs focused on the theoretical value and discuss how hypothetically the AATs may be beneficial to patients and their perceived loneliness, stress, anxiety, interactions with others, and depression. These projects offer strong suggestions on future research projects regarding the value of AAT.
The prior research is encouraging to the idea that AATs may be beneficial in out-patient settings to Psychiatrists working with depression and anxiety. Given these prior publications, a desire for further evidence and a project validated by commonly used Psychiatry assessments is proposed here.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal assisted therapy cohort | Experimental | Other: Animal assisted therapy cohortThis arm will be the group that is randomized to receiving animal assisted therapy during outpatient office visits. |
| Control therapy cohort | No intervention | –This arm will be the group that will receive the standard outpatient psychiatric treatment without animal therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatient psychiatric patients of Dr. Matt Kern who meet the criteria to be diagnosed with Major Depressive Disorder and/or Generalized Anxiety Disorder via Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder (GAD-7)
Key exclusion criteria (3 listed)
- Prior history of animal related trauma
- Participants that require psychiatric hospitalization during the experiment will have their information excluded from analysis
- Participants who have changes made to any Hypertension / Blood Pressure medications during the experiment will have their Blood Pressure measurements removed from final analysis
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 therapy cohortA therapy dog will be present in the room during the routine outpatient psychiatric visit. | Other | Animal assisted therapy cohort |
Primary outcome
General Anxiety Disorder-7 (GAD-7) scores
Time frame: Month 6
The GAD-7 scores will be collected during the duration of the study and then analyzed upon completion to determine if any significant differences are observed between study arms - a score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7
Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: Month 6
The PHQ-9 scores will be collected during the duration of the study and then analyzed upon completion to determine if any significant differences are observed between study arms - score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression
Three-Item Loneliness Scale (TIL) scores
Time frame: Month 6
The TIL scores will be collected during the duration of the study and then analyzed upon completion to determine if any significant differences are observed between study arms - Each question is rated on a 3-point scale: 1 = Hardly Ever; 2 = Some of the Time; 3 = Often. All items are summed to give a total score
1 secondary outcome
Mean Arterial Blood Pressure
Time frame: Month 6
Results and safety
The study was stopped early (reason given: IRB Concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Animal-assisted therapy on happiness and life quality of chronic psychiatric patients living in psychiatric residential care homes: a randomized controlled studyLink provided by the sponsor.
- 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.
Matt Kern, MD principal investigator
Wake Forest University Health Sciences
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 therapy cohort in people with Anxiety and Depression, run by Wake Forest University Health Sciences 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 1 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: stopped early, as of the sponsor's last update on 5 Jun 2023. 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 was stopped early (reason given: IRB Concerns). Results are not available in the source record.
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?
General Anxiety Disorder-7 (GAD-7) scores (time frame: Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.