e-Mindfulness for Depression in Older Adults (MMW)

A Clinical Trial to Assess the Effect of Internet-delivered Mindfulness on Depressive Symptoms and Cognitive Function in Older Adults With Major Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; Mental Health Disorder
• Intervention / Treatment: Behavioral: Mindful My Way

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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine, Health Mind Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; This group will be given the Mindfulness mobile intervention, Mindful My Way (MMW)	Behavioral: 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 Names: MMW

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMA Depression Scale	Scale Range: 0-8 (0-no depressive symptoms; 8-worst depressive symptoms measurable with this scale)	Change from baseline, established during the 4 weeks preceding the intervention, which will be measured in the 4 weeks following completion of the intervention

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Mental Disorders
• Other Study ID Numbers: 201811036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No