Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249116
• Other study ID #: 1R03HD091892-01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Fear of dogs

• Allergy to dogs

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety
• Social Anxiety Disorder
• Social Anxiety Disorder of Childhood

Intervention

Other:
• animal-assisted intervention
Interaction with a therapy dog
• active control
Interaction with a stuffed dog

Locations

Country	Name	City	State
United States	Cummings School of Veterinary Medicine at Tufts University	North Grafton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Continuous through the 2 hour experiment.
Secondary	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.	continuous through the 2 hour experiment
Secondary	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.	1 hour into 2 hour experiment
Secondary	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.	1 hour into 2 hour experiment