Social Anxiety Disorder Clinical Trial
Official title:
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety
Verified date | September 2020 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cummings School of Veterinary Medicine at Tufts University | North Grafton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University |
United States,
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 |
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