AnxietyNCT04562948
Community Applications of the MindShift App
An observational study of Anxiety and Depression, run by University of Windsor at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Anxiety Generalized
- How many people
- 380 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2020to 12 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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. Seminal work from Statistics Canada has emphasized the need for greater access to psychotherapy in Canada. Moreover, 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. The internet and smartphones provide a novel format to provide information and relevant skills to a large number of users. Recent research indicates that internet-based variants of cognitive behavioural therapy may be efficacious treatments for anxiety and depressive disorders among other conditions. Critically, internet-based treatments are scalable; resources can be provided to many people instantaneously to help them in crises, such as the COVID-19 pandemic. Further study is needed to identify who may benefit from internet-based treatment or require psychotherapy in a more traditional format. For example, whereas mental health professionals receive extensive training in assessment and case formulation to adapt treatments to individuals, internet-based resources are fixed. However, their fixed nature allows internet-based resources to offer a range of tools for users to try in a process of finding those that benefit them in particular situations. Moreover, the ability to access resources on demand presents a unique benefit of internet-based treatments that may support goals of traditional psychotherapy formats to generalize skills into individuals' daily lives. Anxiety disorders are also frequently comorbid with myriad other psychological and psychiatric conditions. Existing treatments for other conditions are often complicated by the presence of a comorbid anxiety disorder, which may be associated with poorer prognosis. Whereas traditional psychotherapy formats consider how to organize treatment for multiple comorbid conditions, internet- and smartphone-enabled resources may help individuals manage concurrent anxiety to support traditional treatment in addressing comorbid conditions. For example, anxiety disorders are often comorbid with substance use disorders; internet- and smartphone-based resources for anxiety disorders may, therefore, supplement existing treatments for substance use disorders for some individuals.
In recent years, there has been a proliferation of smartphone-based apps advertised to help users' mental health and wellness. While many of these apps may use principles of evidence-based treatments, the efficacy, effectiveness, or clinical utility of most apps has not been empirically supported. Overall, internet-based mental health resources may provide useful help to people for whom traditional psychotherapy is not yet available or to augment existing treatment such as through helping to generalize therapeutic skills into one's daily life. 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. Specifically, the research team will examine person-specific and contextual moderators of change over time. For example, the person-specific moderator of baseline anxiety severity may demonstrate a non-linear association with change in anxiety severity over time, which would indicate that the smartphone-based resource is more helpful for individuals in a given range of baseline anxiety severity (e.g., low to moderate) while other treatment formats should be considered for individuals with severe baseline anxiety. Similarly, differences in the rate of anxiety symptom change over time will examine whether use of the app is associated with greater reductions in anxiety and distress when used alone or as an adjunct to traditional psychotherapy or pharmacotherapy. Finally, by examining comorbid conditions and concurrent treatments as moderators of change in anxiety severity over time, the present study will provide some of the first indications of whether use of the MindShift smartphone app to manage anxiety supports existing treatments for conditions frequently comorbid with anxiety disorders.
Adult participants 18 years of age and older will be recruited from Canada and the United States of America using a variety of online platforms and list serves. 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.
- Keywords
- eMental Health, mHealth, Anxiety
- Medical subject headings
- Anxiety Disorders, Depression, Generalized Anxiety Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (3)
Linear and non-linear change in depressive symptom severity over 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.
Measured: 16 weeks
Linear and non-linear change in functional impairment over 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.
Measured: 16 weeks
Linear and non-linear change in life satisfaction over 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start11 Nov 2020
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Windsor
- Sponsor type
- University, hospital or other
- Collaborators
- Anxiety Canada
- Responsible party
- Principal investigator, Lance M. Rappaport, University of Windsor
- Investigators
- Lance M Rappaport, Ph.D., Principal investigator, University of Windsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562948
- Sponsor's protocol ID
- MindShift
- Status last verified
- Oct 2022
- First submitted
- 11 Sep 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1.
PubMed 29422409Chorpita BF. Modular cognitive-behavioral therapy for childhood anxiety disorders. 2007: Guilford Press.
Clark LA, Watson D. Tripartite model of anxiety and depression: psychometric evidence and taxonomic implications. J Abnorm Psychol. 1991 Aug;100(3):316-36. doi: 10.1037//0021-843x.100.3.316.
PubMed 1918611Forand NR, Huibers MJH, DeRubeis RJ. Prognosis moderates the engagement-outcome relationship in unguided cCBT for depression: A proof of concept for the prognosis moderation hypothesis. J Consult Clin Psychol. 2017 May;85(5):471-483. doi: 10.1037/ccp0000182. Epub 2017 Feb 2.
PubMed 28150952Grant BF, Stinson FS, Dawson DA, Chou SP, Dufour MC, Compton W, Pickering RP, Kaplan K. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2004 Aug;61(8):807-16. doi: 10.1001/archpsyc.61.8.807.
PubMed 15289279Hasin D, Kilcoyne B. Comorbidity of psychiatric and substance use disorders in the United States: current issues and findings from the NESARC. Curr Opin Psychiatry. 2012 May;25(3):165-71. doi: 10.1097/YCO.0b013e3283523dcc.
PubMed 22449770Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
PubMed 23459093Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.
PubMed 15939839Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.
PubMed 9107147Kessler RC, Gruber M, Hettema JM, Hwang I, Sampson N, Yonkers KA. Co-morbid major depression and generalized anxiety disorders in the National Comorbidity Survey follow-up. Psychol Med. 2008 Mar;38(3):365-74. doi: 10.1017/S0033291707002012. Epub 2007 Nov 30.
PubMed 18047766Khantzian EJ. The self-medication hypothesis of substance use disorders: a reconsideration and recent applications. Harv Rev Psychiatry. 1997 Jan-Feb;4(5):231-44. doi: 10.3109/10673229709030550.
PubMed 9385000Loucas CE, Fairburn CG, Whittington C, Pennant ME, Stockton S, Kendall T. E-therapy in the treatment and prevention of eating disorders: A systematic review and meta-analysis. Behav Res Ther. 2014 Dec;63:122-31. doi: 10.1016/j.brat.2014.09.011. Epub 2014 Oct 5.
PubMed 25461787Mohr DC, Burns MN, Schueller SM, Clarke G, Klinkman M. Behavioral intervention technologies: evidence review and recommendations for future research in mental health. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):332-8. doi: 10.1016/j.genhosppsych.2013.03.008. Epub 2013 May 8.
PubMed 23664503Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2016 Mar 12;3(3):CD011565. doi: 10.1002/14651858.CD011565.pub2.
PubMed 26968204Paschou M, Sakkopoulos E, Tsakalidis A. easyHealthApps: e-Health Apps dynamic generation for smartphones & tablets. J Med Syst. 2013 Jun;37(3):9951. doi: 10.1007/s10916-013-9951-6. Epub 2013 May 12.
PubMed 23666429
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Applications of the MindShift App
- ClinicalTrials.gov ID
- NCT04562948
- Acronym / sponsor ID
- MindShift
- Keywords
- eMental Health, mHealth, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of WindsorUniversity, hospital or other
- Collaborators
- Anxiety Canada
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Seminal work from Statistics Canada has emphasized the need for greater access to psychotherapy in Canada. Moreover, 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. The internet and smartphones provide a novel format to provide information and relevant skills to a large number of users. Recent research indicates that internet-based variants of cognitive behavioural therapy may be efficacious treatments for anxiety and depressive disorders among other conditions. Critically, internet-based treatments are scalable; resources can be provided to many people instantaneously to help them in crises, such as the COVID-19 pandemic. Further study is needed to identify who may benefit from internet-based treatment or require psychotherapy in a more traditional format. For example, whereas mental health professionals receive extensive training in assessment and case formulation to adapt treatments to individuals, internet-based resources are fixed. However, their fixed nature allows internet-based resources to offer a range of tools for users to try in a process of finding those that benefit them in particular situations. Moreover, the ability to access resources on demand presents a unique benefit of internet-based treatments that may support goals of traditional psychotherapy formats to generalize skills into individuals' daily lives. Anxiety disorders are also frequently comorbid with myriad other psychological and psychiatric conditions. Existing treatments for other conditions are often complicated by the presence of a comorbid anxiety disorder, which may be associated with poorer prognosis. Whereas traditional psychotherapy formats consider how to organize treatment for multiple comorbid conditions, internet- and smartphone-enabled resources may help individuals manage concurrent anxiety to support traditional treatment in addressing comorbid conditions. For example, anxiety disorders are often comorbid with substance use disorders; internet- and smartphone-based resources for anxiety disorders may, therefore, supplement existing treatments for substance use disorders for some individuals.
In recent years, there has been a proliferation of smartphone-based apps advertised to help users' mental health and wellness. While many of these apps may use principles of evidence-based treatments, the efficacy, effectiveness, or clinical utility of most apps has not been empirically supported. Overall, internet-based mental health resources may provide useful help to people for whom traditional psychotherapy is not yet available or to augment existing treatment such as through helping to generalize therapeutic skills into one's daily life. 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. Specifically, the research team will examine person-specific and contextual moderators of change over time. For example, the person-specific moderator of baseline anxiety severity may demonstrate a non-linear association with change in anxiety severity over time, which would indicate that the smartphone-based resource is more helpful for individuals in a given range of baseline anxiety severity (e.g., low to moderate) while other treatment formats should be considered for individuals with severe baseline anxiety. Similarly, differences in the rate of anxiety symptom change over time will examine whether use of the app is associated with greater reductions in anxiety and distress when used alone or as an adjunct to traditional psychotherapy or pharmacotherapy. Finally, by examining comorbid conditions and concurrent treatments as moderators of change in anxiety severity over time, the present study will provide some of the first indications of whether use of the MindShift smartphone app to manage anxiety supports existing treatments for conditions frequently comorbid with anxiety disorders.
Adult participants 18 years of age and older will be recruited from Canada and the United States of America using a variety of online platforms and list serves. 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Linear and non-linear change in depressive symptom severity over 16 weeks
Time frame: 16 weeks
Linear and non-linear change in functional impairment over 16 weeks
Time frame: 16 weeks
Linear and non-linear change in life satisfaction over 16 weeks
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 29422409Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1.
- BackgroundChorpita BF. Modular cognitive-behavioral therapy for childhood anxiety disorders. 2007: Guilford Press.
- Background: PubMed 1918611Clark LA, Watson D. Tripartite model of anxiety and depression: psychometric evidence and taxonomic implications. J Abnorm Psychol. 1991 Aug;100(3):316-36. doi: 10.1037//0021-843x.100.3.316.
- Background: PubMed 28150952Forand NR, Huibers MJH, DeRubeis RJ. Prognosis moderates the engagement-outcome relationship in unguided cCBT for depression: A proof of concept for the prognosis moderation hypothesis. J Consult Clin Psychol. 2017 May;85(5):471-483. doi: 10.1037/ccp0000182. Epub 2017 Feb 2.
- Background: PubMed 15289279Grant BF, Stinson FS, Dawson DA, Chou SP, Dufour MC, Compton W, Pickering RP, Kaplan K. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2004 Aug;61(8):807-16. doi: 10.1001/archpsyc.61.8.807.
- Background: PubMed 22449770Hasin D, Kilcoyne B. Comorbidity of psychiatric and substance use disorders in the United States: current issues and findings from the NESARC. Curr Opin Psychiatry. 2012 May;25(3):165-71. doi: 10.1097/YCO.0b013e3283523dcc.
- Background: PubMed 23459093Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
- Background: PubMed 15939839Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.
- Background: PubMed 9107147Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.
- Background: PubMed 18047766Kessler RC, Gruber M, Hettema JM, Hwang I, Sampson N, Yonkers KA. Co-morbid major depression and generalized anxiety disorders in the National Comorbidity Survey follow-up. Psychol Med. 2008 Mar;38(3):365-74. doi: 10.1017/S0033291707002012. Epub 2007 Nov 30.
- Background: PubMed 9385000Khantzian EJ. The self-medication hypothesis of substance use disorders: a reconsideration and recent applications. Harv Rev Psychiatry. 1997 Jan-Feb;4(5):231-44. doi: 10.3109/10673229709030550.
- Background: PubMed 25461787Loucas CE, Fairburn CG, Whittington C, Pennant ME, Stockton S, Kendall T. E-therapy in the treatment and prevention of eating disorders: A systematic review and meta-analysis. Behav Res Ther. 2014 Dec;63:122-31. doi: 10.1016/j.brat.2014.09.011. Epub 2014 Oct 5.
- Individual participant dataSharing planned: No. 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.
Related trials for Anxiety
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lance M Rappaport, Ph.D. principal investigator
University of Windsor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by University of Windsor at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear and non-linear change in generalized anxiety severity over 16 weeks (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562948, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.