Back to resultse-Mindfulness for Depression in Older Adults (MMW)
Primary Purpose
Depression, Mental Health Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful My Way
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- Washington University School of Medicine, Health Mind Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness
Arm Description
This group will be given the Mindfulness mobile intervention, Mindful My Way (MMW)
Outcomes
Primary Outcome Measures
EMA Depression Scale
Scale Range: 0-8 (0-no depressive symptoms; 8-worst depressive symptoms measurable with this scale)
Secondary Outcome Measures
Full Information
NCT ID
NCT03922217
First Posted
March 13, 2019
Last Updated
January 27, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03922217
Brief Title
e-Mindfulness for Depression in Older Adults
Acronym
MMW
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study 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.
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 or RedCap survey, 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mental Health Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open label
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
This group will be given the Mindfulness mobile intervention, Mindful My Way (MMW)
Intervention Type
Device
Intervention Name(s)
Mindful My Way
Other Intervention Name(s)
MMW
Intervention Description
Mindful My Way (MMW) is a mobile application created for iOS, designed to delivered a form of mindfulness-based therapy to depressed older adults
Primary Outcome Measure Information:
Title
EMA Depression Scale
Description
Scale Range: 0-8 (0-no depressive symptoms; 8-worst depressive symptoms measurable with this 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Washington University School of Medicine, Health Mind Lab
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36301604
Citation
Schweiger A, Rodebaugh TL, Lenze EJ, Keenoy K, Hassenstab J, Kloeckner J, Gettinger TR, Nicol GE. Mindfulness Training for Depressed Older Adults Using Smartphone Technology: Protocol for a Fully Remote Precision Clinical Trial. JMIR Res Protoc. 2022 Oct 27;11(10):e39233. doi: 10.2196/39233.
Results Reference
derived
Learn more about this trial
e-Mindfulness for Depression in Older Adults
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