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Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

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ClinicalTrials.gov Identifier: NCT03249116
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Tufts University

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Social Anxiety Social Anxiety Disorder of Childhood Other: animal-assisted intervention Other: active control Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Control
Active control - interaction with a therapy dog
Other: active control
Interaction with a stuffed dog

Experimental: Therapy dog - social
animal-assisted intervention - social interaction only with therapy dog during TSST.
Other: animal-assisted intervention
Interaction with a therapy dog

Experimental: Therapy dog - Social + physical
animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.
Other: animal-assisted intervention
Interaction with a therapy dog




Primary Outcome Measures :
  1. Self-reported affective experience [ Time Frame: change in state-level anxiety from baseline to recovery (2 hours) ]
    State-Trait Anxiety Inventory (state scale)


Secondary Outcome Measures :
  1. Autonomic physiological reactivity [ Time Frame: continuous through the 2 hour experiment ]
    heart rate

  2. Cognitive performance - number of errors [ Time Frame: 1 hour into 2 hour experiment ]
    number of errors during mental math task

  3. Cognitive performance - lowest number reached [ Time Frame: 1 hour into 2 hour experiment ]
    lowest number reached by participants on the mental math task



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Fear of dogs
  • Allergy to dogs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249116


Contacts
Contact: Megan K Mueller, PhD 508-887-4543 megan.mueller@tufts.edu

Locations
United States, Massachusetts
Cummings School of Veterinary Medicine at Tufts University Recruiting
North Grafton, Massachusetts, United States, 01536
Contact: Megan K Mueller, PhD    508-887-4543    megan.mueller@tufts.edu   
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Megan K Mueller, PhD Tufts University

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03249116     History of Changes
Other Study ID Numbers: 1R03HD091892-01 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tufts University:
human-animal interaction
animal-assisted intervention

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders