An interventional study of Animal assisted therapy cohort in Anxiety, Depression and Psychiatric or Mood Diseases or Conditions, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 7 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
This arm will be the group that is randomized to receiving animal assisted therapy during outpatient office visits.
Other: Animal assisted therapy cohort
This arm will be the group that will receive the standard outpatient psychiatric treatment without animal therapy.
A therapy dog will be present in the room during the routine outpatient psychiatric visit.
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
Time frame: 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
Time frame: 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
Time frame: Month 6
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
Time frame: Month 6
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Plan to share: No
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences