e-Mindfulness for Depression (MMW)
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|ClinicalTrials.gov Identifier: NCT03922217|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression Mental Health Disorder||Device: Mindful My Way||Not Applicable|
The investigators will conduct a clinical trial using a smartphone app to collect data on depressive symptoms and cognitive function, and a website to deliver pre-recorded mindfulness sessions. The clinical trial will evaluate feasibility, acceptability, and efficacy with respect to depressive and cognitive symptoms, in a population of older adults at least 65 years of age with a current, active major depressive episode. This online, internet-delivered mindfulness meditation course is termed "Mindful My Way", consisting of 10 approximately one-hour classes consisting of mindfulness content (e.g., meditations) that a participant can watch on his or her computer or mobile device.
Assessment measures include a baseline diagnostic and screening assessment conducted by phone, plus:
- Pre-mindfulness and post-mindfulness : (a) (1) 4 weeks of cognitive testing delivered via app (brief game-like tests delivered up to 4 times daily); and (2) 4 weeks of depressive symptom surveys (8 depressive symptoms delivered 4 times daily) end of study, (b) a MADRS via phone interview (brief clinical interview of depressive symptom severity).
- During the mindfulness class: questions on participant preferences in order to evaluate the feasibility and acceptability of the mindfulness course, delivered via app.
All of these remote smartphone-based assessment techniques have been previously used in Wash U IRB-approved studies. (IRB # 201612089, IRB # 201709118).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|Official Title:||A Clinical Trial to Assess the Effect of Internet-delivered Mindfulness on Depressive Symptoms and Cognitive Function in Older Adults With Major Depression|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||March 5, 2020|
|Estimated Study Completion Date :||March 5, 2020|
This group will be given the Mindfulness mobile intervention, Mindful My Way (MMW)
Device: Mindful My Way
Mindful My Way (MMW) is a mobile application created for iOS, designed to delivered a form of mindfulness-based therapy to depressed older adults
Other Name: MMW
- EMA Depression Scale [ Time Frame: Change from baseline, established during the 4 weeks preceding the intervention, which will be measured in the 4 weeks following completion of the intervention ]Scale Range: 0-8 (0-no depressive symptoms; 8-worst depressive symptoms measurable with this scale)
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): NCT03922217
|Contact: Aaron Mofsen, MDfirstname.lastname@example.org|
|Contact: Julie Schweigeremail@example.com|
|United States, Missouri|
|Washington University School of Medicine, Health Mind Lab||Recruiting|
|Saint Louis, Missouri, United States, 63108|
|Contact: Mary Stephens, BS 314-747-1134 firstname.lastname@example.org|