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The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics

The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05326074
Enrollment
7
Registered
2022-04-13
Start date
2022-07-08
Completion date
2022-08-11
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Psychiatric or Mood Diseases or Conditions

Keywords

Animal Assisted Therapy, Loneliness, Depression, Anxiety

Brief 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 (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.

Interventions

OTHERAnimal assisted therapy cohort

A therapy dog will be present in the room during the routine outpatient psychiatric visit.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
General Anxiety Disorder-7 (GAD-7) scoresMonth 6The 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) scoresMonth 6The 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) scoresMonth 6The 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

Secondary

MeasureTime frameDescription
Mean Arterial Blood PressureMonth 6Blood Pressure measurements will be taken before and after outpatient visits for all study participants and then compared upon completion of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026