DepressionMMWNCT03922217
e-Mindfulness for Depression in Older Adults
A study testing Mindful My Way in people with Depression and Mental Health Disorder, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Mental Health Disorder
- What is being tested?
- Mindful My Way
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine, Health Mind Lab
St Louis, Missouri, 63108
About this study
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
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.
Read the 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).
- Conditions
- Depression, Mental Health Disorder
- Being tested
- Mindful My Way
- Medical subject headings
- Depression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful My WayBehavioural
Also called MMW
Mindful My Way (MMW) is a mobile application created for iOS, designed to delivered a form of mindfulness-based therapy to depressed older adults
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | This group will be given the Mindfulness mobile intervention, Mindful My Way (MMW) Receives: Behavioral: Mindful My Way |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMA Depression Scale
Scale Range: 0-8 (0-no depressive symptoms; 8-worst depressive symptoms measurable with this scale)
Measured: Change from baseline, established during the 4 weeks preceding the intervention, which will be measured in the 4 weeks following completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start28 Mar 2019
- Primary completion5 Dec 2022
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Lenze, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922217
- Sponsor's protocol ID
- 201811036
- Acronym
- MMW
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2019
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36301604
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03922217
- Acronym / sponsor ID
- MMW / 201811036
- Conditions
- Depression, Mental Health Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindful My WayThis group will be given the Mindfulness mobile intervention, Mindful My Way (MMW) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful My WayAlso: MMWMindful My Way (MMW) is a mobile application created for iOS, designed to delivered a form of mindfulness-based therapy to depressed older adults | Behavioural | Mindfulness |
Primary outcome
EMA Depression 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
Scale Range: 0-8 (0-no depressive symptoms; 8-worst depressive symptoms measurable with this scale)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Derived from this study: PubMed 36301604Schweiger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful My Way in people with Depression and Mental Health Disorder, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMA Depression 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.