The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics

NCT ID: NCT05326074

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2022-08-11

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.

Conditions

Anxiety; Depression; Psychiatric or Mood Diseases or Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Animal assisted therapy cohort

This arm will be the group that is randomized to receiving animal assisted therapy during outpatient office visits.

Group Type: EXPERIMENTAL

Animal assisted therapy cohort

Intervention Type: OTHER

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

Control therapy cohort

This arm will be the group that will receive the standard outpatient psychiatric treatment without animal therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Animal assisted therapy cohort

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Kern, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-020-02980-8

Animal-assisted therapy on happiness and life quality of chronic psychiatric patients living in psychiatric residential care homes: a randomized controlled study

Other Identifiers

IRB00080233

Identifier Type: -

Identifier Source: org_study_id