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Clinical Trials/NCT05326074
NCT05326074
Terminated
Not Applicable

The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics

Wake Forest University Health Sciences1 site in 1 country7 target enrollmentJuly 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Wake Forest University Health Sciences
Enrollment
7
Locations
1
Primary Endpoint
General Anxiety Disorder-7 (GAD-7) scores
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2022
End Date
August 11, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Mean Arterial Blood Pressure(Month 6)

Study Sites (1)

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