Community Applications of the MindShift App

NCT04562948 | Completed

• 1 other identifier: MindShift
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

Despite considerable, replicated evidence of the efficacy and effectiveness of cognitive behavioural therapy, there is an insufficient number of professionals (e.g., psychologists, psychiatrists) in North America to provide evidence-based psychotherapy to all who need it. For example, in light of the COVID-19 pandemic, there is a greater need for resources that are scalable to help a large portion of the public to manage anxiety and attendant psychological distress. One promising avenue to increase the availability of evidence-based mental healthcare relies on technological developments, such as smartphone-enabled apps, to disseminate principles derived from existing evidence-based psychotherapies. However, further research is needed to understand for whom and in what contexts internet- and smartphone-enabled resources are helpful. The present study will examine the utility of one such smartphone enabled app, MindShift, developed by Anxiety Canada in consultation with Canadian and American experts in evidence-based psychotherapy for anxiety disorders. Specifically, the main aim of the present study is to evaluate the effectiveness of the MindShift app to help users manage anxiety and related psychological distress as compared to anxiety and distress prior to app use. Two secondary, exploratory aims of the present study are to examine possible moderators that indicate for whom or in what contexts use of the MindShift app is particularly helpful. Adult participants 18 years of age and older will be recruited from Canada and the United States of America. Following informed consent, participants will complete baseline assessment of anxiety symptom severity, depressive symptom severity, daily functional impairment, quality of life, alcohol use, use of illicit psychoactive substances, stress associated with the COVID-19 pandemic, and demographic information. Following baseline assessment, participants will be instructed in downloading the MindShift app to their personal mobile phone running either iOS or Android OS software. Participants will then use the MindShift app as they choose for the 16-week duration of the study. Finally, participants will be asked to complete follow-up assessments 2, 4, 8, 12, and 16 weeks following baseline assessment. Follow-up assessments will assess anxiety symptom severity, depressive symptom severity, functional impairment, and quality of life satisfaction on the same measures administered at baseline.

Conditions

Anxiety; Depression; Anxiety Generalized; Anxiety Disorders and Symptoms

Keywords

eMental Health; mHealth; Anxiety

Outcome Measures

Primary Outcomes (1)

• Linear and non-linear change in generalized anxiety severity over 16 weeks

  The Generalized Anxiety Disorder 7-item scale (GAD-7) assesses self-reported severity of generalized anxiety symptoms over the past 2 weeks, specifically symptoms associated with Generalized Anxiety Disorder. The minimum score is 0; the maximum score is 21. Higher scores indicate greater levels of symptom severity. The GAD-7 will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. The primary outcome measure is linear and non-linear change in generalized anxiety symptom severity over 16 weeks.

  16 weeks

Secondary Outcomes (3)

• Linear and non-linear change in depressive symptom severity over 16 weeks

  16 weeks

• Linear and non-linear change in functional impairment over 16 weeks

  16 weeks

• Linear and non-linear change in life satisfaction over 16 weeks

  16 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults in Canada and the United States of America recruited through the Anxiety Canada website; advertisements on social media; and email announcements to Canadian and American psychologists and psychiatrists.

You may qualify if:

• Resident of Canada or the United States of America
• Report any distress related to anxiety
• Are sufficiently comfortable with the English Language to complete study measures
• Have regular access to a smartphone or mobile device that runs the Android or iOS operating systems. This is required to download and use the MindShift app.
• Have semi-regular access to the internet through a computer or mobile device, which is required to complete study assessments.

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Windsor: lead
• Anxiety Canada: collaborator

Study Sites (1)

University of Windsor

Windsor, Ontario, N9B 3P4, Canada

Location

Related Publications (18)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lance M Rappaport, Ph.D.

  University of Windsor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 24, 2020
• Study Start: November 11, 2020
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)