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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Massachusetts
      • North Grafton, Massachusetts, United States, 01536
        • Cummings School of Veterinary Medicine at Tufts University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Control - interaction with a stuffed dog
Active control - interaction with a stuffed dog
Other: active control
Interaction with a stuffed dog
EXPERIMENTAL: Therapy dog - social
animal-assisted intervention - social interaction only with therapy dog during stress task.
Other: animal-assisted intervention
Interaction with a therapy dog
EXPERIMENTAL: Therapy dog - Social + physical
animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.
Other: animal-assisted intervention
Interaction with a therapy dog

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
1 hour into 2 hour experiment
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.
1 hour into 2 hour experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tufts University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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