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Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

Primary Purpose

Social Anxiety Disorder, Social Anxiety, Social Anxiety Disorder of Childhood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
animal-assisted intervention
active control
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Social Anxiety Disorder focused on measuring human-animal interaction, animal-assisted intervention

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Fear of dogs
  • Allergy to dogs

Sites / Locations

  • Cummings School of Veterinary Medicine at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control - interaction with a stuffed dog

Therapy dog - social

Therapy dog - Social + physical

Arm Description

Active control - interaction with a stuffed dog

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Autonomic Physiological Reactivity: Electrodermal Activity
Electrodermal activity (EDA) was recorded at 4 Hz by an Empatica E4 wristband sensor. EDA is reported in μSiemens with higher values representing higher levels of autonomic reactivity. EDA was recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration.
Autonomic Reactivity: Heart Rate
Heart rate (beats per minute) Heart rate was measured via photoplethysmography from the Empatica E4 wristband using Empatica's proprietary algorithm, which automatically imputes missing data from the photoplethysmograph signal and corrects for motion artifacts. The heart rate is computed as the average heart rate values that spans 10 seconds. This average HR is computed at 1 Hz. HRwas recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration.
Cognitive Performance - Number of Errors
Number of errors (incorrect answer to subtraction task) during mental math task; better performance was characterized by fewer errors. Number of errors ranged from 0 to 8.
Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses
Highest number of correct responses in serial subtraction task. To adjust for the different levels of subtraction based on age level, lowest number reached was operationalized by calculating the number of correct responses (a higher score indicating better performance). Number of correct answers ranged from 1 to 41.

Full Information

First Posted
August 8, 2017
Last Updated
September 12, 2020
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT03249116
Brief Title
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions
Official Title
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Social Anxiety, Social Anxiety Disorder of Childhood
Keywords
human-animal interaction, animal-assisted intervention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - interaction with a stuffed dog
Arm Type
Active Comparator
Arm Description
Active control - interaction with a stuffed dog
Arm Title
Therapy dog - social
Arm Type
Experimental
Arm Description
animal-assisted intervention - social interaction only with therapy dog during stress task.
Arm Title
Therapy dog - Social + physical
Arm Type
Experimental
Arm Description
animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.
Intervention Type
Other
Intervention Name(s)
animal-assisted intervention
Intervention Description
Interaction with a therapy dog
Intervention Type
Other
Intervention Name(s)
active control
Intervention Description
Interaction with a stuffed dog
Primary Outcome Measure Information:
Title
Self-reported Affective Experience
Description
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).
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.
Secondary Outcome Measure Information:
Title
Autonomic Physiological Reactivity: Electrodermal Activity
Description
Electrodermal activity (EDA) was recorded at 4 Hz by an Empatica E4 wristband sensor. EDA is reported in μSiemens with higher values representing higher levels of autonomic reactivity. EDA was recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration.
Time Frame
Continuous through the 2 hour experiment.
Title
Autonomic Reactivity: Heart Rate
Description
Heart rate (beats per minute) Heart rate was measured via photoplethysmography from the Empatica E4 wristband using Empatica's proprietary algorithm, which automatically imputes missing data from the photoplethysmograph signal and corrects for motion artifacts. The heart rate is computed as the average heart rate values that spans 10 seconds. This average HR is computed at 1 Hz. HRwas recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration.
Time Frame
continuous through the 2 hour experiment
Title
Cognitive Performance - Number of Errors
Description
Number of errors (incorrect answer to subtraction task) during mental math task; better performance was characterized by fewer errors. Number of errors ranged from 0 to 8.
Time Frame
1 hour into 2 hour experiment
Title
Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses
Description
Highest number of correct responses in serial subtraction task. To adjust for the different levels of subtraction based on age level, lowest number reached was operationalized by calculating the number of correct responses (a higher score indicating better performance). Number of correct answers ranged from 1 to 41.
Time Frame
1 hour into 2 hour experiment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Low, mid-range, and high levels of social anxiety Exclusion Criteria: Fear of dogs Allergy to dogs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan K Mueller, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cummings School of Veterinary Medicine at Tufts University
City
North Grafton
State/Province
Massachusetts
ZIP/Postal Code
01536
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33650444
Citation
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.
Results Reference
derived

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Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

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