- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249116
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions
September 12, 2020 updated by: Megan K Mueller, Tufts University
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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North Grafton, Massachusetts, United States, 01536
- Cummings School of Veterinary Medicine at Tufts University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Low, mid-range, and high levels of social anxiety
Exclusion Criteria:
- Fear of dogs
- Allergy to dogs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control - interaction with a stuffed dog
Active control - interaction with a stuffed dog
|
Interaction with a stuffed dog
|
EXPERIMENTAL: Therapy dog - social
animal-assisted intervention - social interaction only with therapy dog during stress task.
|
Interaction with a therapy dog
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EXPERIMENTAL: Therapy dog - Social + physical
animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.
|
Interaction with a therapy dog
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomic Physiological Reactivity: Electrodermal Activity
Time Frame: Continuous through the 2 hour experiment.
|
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.
|
Autonomic Reactivity: Heart Rate
Time Frame: continuous through the 2 hour experiment
|
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.
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continuous through the 2 hour experiment
|
Cognitive Performance - Number of Errors
Time Frame: 1 hour into 2 hour experiment
|
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.
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1 hour into 2 hour experiment
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Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses
Time Frame: 1 hour into 2 hour experiment
|
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.
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1 hour into 2 hour experiment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Megan K Mueller, PhD, Tufts University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
September 1, 2019
Study Completion (ACTUAL)
September 1, 2019
Study Registration Dates
First Submitted
August 8, 2017
First Submitted That Met QC Criteria
August 10, 2017
First Posted (ACTUAL)
August 15, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2020
Last Update Submitted That Met QC Criteria
September 12, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R03HD091892-01 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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