Clinical trial NCT03922217: e-Mindfulness for Depression in Older Adults
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Mental Health Disorder
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: EMA Depression Scale
timeFrame: Change from baseline, established during the 4 weeks preceding the intervention, which will be measured in the 4 weeks following completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Health Mind Lab
state: Missouri
Study officials:
References:
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.