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Clinical Trials/NCT03249116
NCT03249116
Completed
N/A

Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety

Tufts University1 site in 1 country75 target enrollmentOctober 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Social Anxiety Disorder
Sponsor
Tufts University
Enrollment
75
Locations
1
Primary Endpoint
Self-reported Affective Experience
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
September 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Megan K Mueller

Assistant Professor

Tufts University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Fear of dogs
  • Allergy to dogs

Outcomes

Primary Outcomes

Self-reported Affective Experience

Time Frame: 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.

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).

Secondary Outcomes

  • Autonomic Physiological Reactivity: Electrodermal Activity(Continuous through the 2 hour experiment.)
  • Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses(1 hour into 2 hour experiment)
  • Cognitive Performance - Number of Errors(1 hour into 2 hour experiment)
  • Autonomic Reactivity: Heart Rate(continuous through the 2 hour experiment)

Study Sites (1)

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