Smartwatches to Manage Stress and Anxiety in Residential Settings

NCT04878965 | Completed

• 1 other identifier: 011-2020
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to conduct a prospective evaluation of a smartwatch technology and an associated application (developed by Awake Labs) in a clinical cohort from Centre for Addiction and Mental Health (CAMH) Adult Neurodevelopmental Services (ANS) and adults with developmental disabilities in the community who have received a watch.

Conditions

Baseline; Technology

Keywords

technology; anxiety; IDD/DD

Outcome Measures

Primary Outcomes (3)

• Observed/Self-Reported Emotion

  What is the person's perceived emotion? The person with the ipod (clinician, support worker) will receive a real-time notification when the smartwatch indicates the individual wearing the watch is experiencing strong emotions. The person with the ipod is to indicate which emotion they are experiencing (e.g., anxiety, happiness)

  3 months

• Observed/Self-Reported Antecedent Events

  What was happening before the notification? The person with the ipod (clinician, support worker) will receive a real-time notification when the smartwatch indicates the individual wearing the watch is experiencing strong emotions. The person with the ipod is to indicate what the person who is wearing the smartwatch was doing before immediately before the notification.

  3 months

• Observed/Self-Reported Consequent Events

  What happened after the notification?The person with the ipod (clinician, support worker) will receive a real-time notification when the smartwatch indicates the individual wearing the watch is experiencing strong emotions. The person with the ipod is to indicate what happened once they received the notification (e.g., deep breathing)

  3 months

Secondary Outcomes (3)

• Accuracy

  3 months

• Incident reports

  2-6 months

• PRN

  2-6 months

Study Arms (1)

Smartwatch

OTHER

Individuals receiving the smartwatch

Device: Smartwatch

Interventions

Smartwatch DEVICE

Smartwatch apparatus to measure strong emotions (e.g., anxiety)

Smartwatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with an intellectual and/or developmental disability
• living in the community or receiving services from CAMH ANS department

You may not qualify if:

• Under 18 years old

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health - ANS department

Toronto, Ontario, M6J 1H1, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kendra Thomson, PhD, BCBA-D

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be provided with a smartwatch to wear.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 10, 2021
• Study Start: April 26, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)