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e-Mindfulness for Depression (MMW)

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ClinicalTrials.gov Identifier: NCT03922217
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Study Description
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Brief Summary:
This clinical trial will test whether depression symptoms and cognitive functioning are impacted by internet-delivered mindfulness training following the principles of mindfulness meditation. The population is adults ages 65+ experiencing a current major depressive episode. Participants will receive an approximate 10-week instruction in mindfulness meditation, provided remotely through internet. Outcomes are depressive symptoms, assessed via clinical interview and self-report, and cognitive function, assessed via smartphone-delivered cognitive tests and surveys. The total duration of participation is approximately 18 weeks.

Condition or disease Intervention/treatment Phase
Depression Mental Health Disorder Device: Mindful My Way Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open label
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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, 2021
Estimated Study Completion Date : March 5, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 65 or older
  • DSM-V diagnosis of Major Depressive Disorder or Bipolar, Depressed type and experiencing depressive symptoms consistent with current major depressive episode
  • Not currently psychotic and no history of psychosis within the previous 12 months; psychosis reported in the distant past may not be exclusionary if brief, per PI's judgment
  • English speaking
  • Able to give informed consent
  • iOS smartphone user with internet access
  • iOS operating system 6 or newer
  • Internet access to view internet mindfulness course

Exclusion Criteria:

  • Confirmed psychotic disorder, history of primary post-traumatic stress disorder
  • Current or recent substance use disorder that according to the PI's judgement would confound the interpretation of the study results
  • Any severe Axis II personality disorder or psychotic disorder that, in the PI's judgement, could confound diagnosis or adherence to treatment
  • Meets DSM-V criteria for Mental Retardation
  • Acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others including any prior serious attempts (e.g., those requiring hospitalization) at the PI discretion
  • Current incarceration
  • Inability to cognitively manage the tasks required in this study
  • Unstable medical condition (e.g. uncontrolled diabetes mellitus or hypertension)
  • Concurrent cognitive training, such as brain-training software, regular engagement in mindfulness practice and/or yoga x) significant neurological condition (e.g. stroke, seizure disorder, multiple sclerosis), that in the PI's judgment, could confound the interpretation of study results
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Aaron Mofsen, MD 3143625154 mofsena@wustl.edu
Contact: Julie Schweiger 3143625154 schweigj@wustl.edu

Locations
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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    m.stephens@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
More Information
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Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03922217    
Other Study ID Numbers: 201811036
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders