The Effects of Animal Assisted Therapy in Outpatient Psychiatry Clinics

NCT05326074 | Terminated DMC

• 1 other identifier: IRB00080233
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Psychiatric or Mood Diseases or Conditions

Keywords

Animal Assisted Therapy; Loneliness; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Month 6

Secondary Outcomes (1)

• Mean Arterial Blood Pressure

  Month 6

Study Arms (2)

Animal assisted therapy cohort

EXPERIMENTAL

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

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.

Interventions

Animal assisted therapy cohort OTHER

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

Animal assisted therapy cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Links

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

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Matt Kern, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: July 8, 2022
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: June 5, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)