Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

NCT ID: NCT03249116

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-09-01

Brief Summary

Adolescence and young adulthood is a critical period for the development of social anxiety, which is often linked to other mental health challenges such as depression, mood disorders, and substance abuse. Initial evidence suggests that interacting with animals can reduce stress and anxiety, but no research has tested whether this benefit extends to adolescents at risk for social anxiety disorder. Additionally, researchers and clinicians do not understand what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs). Therefore, the objectives of this study are to explore the specific mechanisms by which interacting with a therapy dog reduces anxiety, and to test whether such an interaction reduces anxiety in adolescents with varying levels of social anxiety.

Detailed Description

The specific aims of this project are to (1) test the mechanisms by which AAIs reduce anxiety, and (2) determine if the anxiolytic effect of social and physical interaction is moderated by level of pre-existing social anxiety. To achieve these aims, 75 adolescents (age 13-17) will undergo a well-validated laboratory-based social evaluative stressor, the Trier Social Stress Task for Children, and be randomly assigned to one of three conditions: 1) no interaction with a dog (control condition), 2) social interaction only (no physical interaction) with a therapy dog; or 3) social interaction plus physical interaction with a therapy dog. Using a multivariate approach, three levels of outcome data will be collected: a) self-reported experience (anxiety), b) autonomic physiology (heart rate), and c) behavioral performance (error rates on mental math task). In addition, the interactions will be videotaped and behavioral coding will be used to explore the specific social behaviors between the participant and the dog that may predict anxiety reduction (such as frequency or type of social referencing or physical contact).

Conditions

Social Anxiety Disorder; Social Anxiety; Social Anxiety Disorder of Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control - interaction with a stuffed dog

Active control - interaction with a stuffed dog

Group Type: ACTIVE_COMPARATOR

active control

Intervention Type: OTHER

Interaction with a stuffed dog

Therapy dog - social

animal-assisted intervention - social interaction only with therapy dog during stress task.

Group Type: EXPERIMENTAL

animal-assisted intervention

Intervention Type: OTHER

Interaction with a therapy dog

Therapy dog - Social + physical

animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.

Group Type: EXPERIMENTAL

animal-assisted intervention

Intervention Type: OTHER

Interaction with a therapy dog

Interventions

animal-assisted intervention

Interaction with a therapy dog

Intervention Type: OTHER

active control

Interaction with a stuffed dog

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Low, mid-range, and high levels of social anxiety

Exclusion Criteria

• Fear of dogs
• Allergy to dogs

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Megan K Mueller

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan K Mueller, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Cummings School of Veterinary Medicine at Tufts University

North Grafton, Massachusetts, United States

Countries

United States

References

Mueller MK, Anderson EC, King EK, Urry HL. Null effects of therapy dog interaction on adolescent anxiety during a laboratory-based social evaluative stressor. Anxiety Stress Coping. 2021 Jul;34(4):365-380. doi: 10.1080/10615806.2021.1892084. Epub 2021 Mar 2.

Reference Type: DERIVED

PMID: 33650444 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R03HD091892-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link