e-Mindfulness for Depression in Older Adults

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03922217
• Other study ID #: 201811036
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: December 5, 2023

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Mental Disorders
• Mental Health Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine, Health Mind Lab	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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