Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

NCT03249116 | Completed Results

• 1 other identifier: 1R03HD091892-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

human-animal interaction; animal-assisted intervention

Outcome Measures

Primary Outcomes (1)

• Self-reported Affective Experience

  The state scale of the State-Trait Anxiety Inventory (STAI) was used to measure state-level anxiety. We used the six-item short form of the STAI, which asks participants to rate how each of the six words reflects their feelings (calm, upset, relaxed, worried, tense, content). The short form was originally administered as a four-point scale, which we further modified to a three-point scale for feasibility in administering repeatedly over a short time period (response options for each item followed the format: very calm, calm, not calm). Responses to the six items were used to create a sum score at each time point with a possible range of 3 to 18 (higher scores indicate higher levels of anxiety).

  Self-reported anxiety was measured at six time points, during: (Time 1; 0 min) baseline, (Time 2; 30 min) anticipation, (Time 3; 35 min) preparation, (Time 4; 45 min) speech, (Time 5; 60 min) recovery period 1, and (Time 6; 75 min) recovery period 2.

Secondary Outcomes (4)

• Autonomic Physiological Reactivity: Electrodermal Activity

  Continuous through the 2 hour experiment.

• Autonomic Reactivity: Heart Rate

  continuous through the 2 hour experiment

• Cognitive Performance - Number of Errors

  1 hour into 2 hour experiment

• Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses

  1 hour into 2 hour experiment

Study Arms (3)

Control - interaction with a stuffed dog

ACTIVE COMPARATOR

Active control - interaction with a stuffed dog

Other: active control

Therapy dog - social

EXPERIMENTAL

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

Other: animal-assisted intervention

Therapy dog - Social + physical

EXPERIMENTAL

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

Other: animal-assisted intervention

Interventions

animal-assisted intervention OTHER

Interaction with a therapy dog

Therapy dog - Social + physical; Therapy dog - social

active control OTHER

Interaction with a stuffed dog

Control - interaction with a stuffed dog

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Fear of dogs
• Allergy to dogs

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Cummings School of Veterinary Medicine at Tufts University

North Grafton, Massachusetts, 01536, United States

Location

Related Publications (1)

• 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.

  PMID: 33650444 DERIVED

MeSH Terms

Conditions

Phobia, Social; Human-Animal Interaction

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Behavior

Limitations and Caveats

Heart rate data was of poor quality due to movement artifacts and therefore unable to be reliably interpreted.

Results Point of Contact

• Title: Dr. Megan K Mueller
• Organization: Tufts University

megan.mueller@tufts.edu

508-887-4543

Study Officials

• Megan K Mueller, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: October 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (1)