Community Applications of the MindShift App
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04562948 |
Recruitment Status :
Completed
First Posted : September 24, 2020
Last Update Posted : November 2, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
Anxiety Depression Anxiety Generalized Anxiety Disorders and Symptoms |
Study Type : | Observational |
Actual Enrollment : | 380 participants |
Observational Model: | Ecologic or Community |
Time Perspective: | Prospective |
Official Title: | Community Applications of the MindShift App |
Actual Study Start Date : | November 11, 2020 |
Actual Primary Completion Date : | April 12, 2022 |
Actual Study Completion Date : | April 12, 2022 |
- Linear and non-linear change in generalized anxiety severity over 16 weeks [ Time Frame: 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.
- Linear and non-linear change in depressive symptom severity over 16 weeks [ Time Frame: 16 weeks ]The Patient Health Questionnaire (PHQ-9) assesses self-reported severity of depressive symptoms over the past 2 weeks. The minimum score is 0; the maximum score is 27. Higher scores indicate greater levels of depressive symptom severity. The PHQ-9 will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. This secondary outcome measure is linear and non-linear change in depressive symptom severity over 16 weeks.
- Linear and non-linear change in functional impairment over 16 weeks [ Time Frame: 16 weeks ]The Work and Social Adjustment Scale (WSAS) assesses self-reported global functional impairment related to physical and psychiatric distress. The minimum score is 0; the maximum score is 40. Higher scores indicate higher levels of functional impairment related to physical and psychiatric distress. The WSAS will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. This secondary outcome measure is linear and non-linear change in functional impairment over 16 weeks.
- Linear and non-linear change in life satisfaction over 16 weeks [ Time Frame: 16 weeks ]The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) assesses one's perceived global quality of life.The minimum score is 16; the maximum score is 80. Higher scores indicate higher levels of life satisfaction. The Q-LES-Q-SF will be administered at baseline and at 2-, 4-, 8-, 12-, and 16-week planned follow up assessments. This secondary outcome measure is linear and non-linear change in life satisfaction over 16 weeks.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562948
Canada, Ontario | |
University of Windsor | |
Windsor, Ontario, Canada, N9B 3P4 |
Principal Investigator: | Lance M Rappaport, Ph.D. | University of Windsor |
Responsible Party: | Lance M. Rappaport, Assistant Professor, University of Windsor |
ClinicalTrials.gov Identifier: | NCT04562948 |
Other Study ID Numbers: |
MindShift |
First Posted: | September 24, 2020 Key Record Dates |
Last Update Posted: | November 2, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | The research team has planned to make data available to other researchers through request to the study principal investigator. Given funding provided by Anxiety Canada and the focused nature of the present study, this IPD plan was considered a careful way to protect potentially identifiable information while limiting the risk that multiple research teams work on identical data analytic projects. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
eMental Health mHealth Anxiety |
Anxiety Disorders Mental Disorders |