NCT03922217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

March 28, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

3.7 years

First QC Date

March 13, 2019

Last Update Submit

July 22, 2024

Conditions

DepressionMental Health Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Mindfulness

EXPERIMENTAL

This group will be given the Mindfulness mobile intervention, Mindful My Way (MMW)

Behavioral: Mindful My Way

Interventions

Mindful My WayBEHAVIORAL

Mindful My Way (MMW) is a mobile application created for iOS, designed to delivered a form of mindfulness-based therapy to depressed older adults

Also known as: MMW
Mindfulness

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine, Health Mind Lab

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • 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.

    PMID: 36301604DERIVED

MeSH Terms

Conditions

DepressionMental Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 13, 2019

First Posted

April 19, 2019

Study Start

March 28, 2019

Primary Completion

December 5, 2022

Study Completion

December 5, 2023

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

US(1)