StressNCT04378530
Mindfulness Takes Practice
A study testing Personalized Anchoring Strategy and Fixed Anchoring Strategy in people with Stress and Habits, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of the study is to optimize the delivery of mHealth tools to support the formation of persistent mindfulness meditation routines. Aim 1: Identify the efficacy of the anchoring strategy on the persistence of daily meditation practice. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Personalized Anchoring Strategy and Fixed Anchoring Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 1 Jun 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or Women
- Between 18 and 60 years of age
- Able to read/understand English
- Have access to a smartphone on a daily basis
- Reside in the US or a US territory
- Willing to be randomized
- Willing to download a mobile application
- Paid for Calm but do not use it OR paid for 60 days and then after 30 days no activity
Who cannot join
- Currently using the Calm app or another meditation app
- Currently participating in >60 mins of meditation/yoga in one month within the last 6 months.
- Currently reside outside the United States
- Email provided is not associated with Calm account
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: Mindfulness Takes Practice: mHealth Tools for Building Persistent Mindfulness Meditation Habits
The purpose of the study is to optimize the delivery of mHealth tools to support the formation of persistent mindfulness meditation routines.
Aim 1: Identify the efficacy of the anchoring strategy on the persistence of daily meditation practice.
Read more
H1: Persistence (measured through repeated observations of panel regression models of the daily likelihood of mindfulness mediation over the 16-week follow-up period) will be greater among AG as compared to CG.
Aim 2: Determine participant phenotypes that are (a) associated with successfully anchoring daily meditation or (b) likely to need additional supports. Potential moderators of the anchoring strategy's success include participants' daily schedule, type of work, household composition, motivation, time and risk preferences, and prior exposure to mindfulness, which will be analyzed in the panel regression model framework above.
Aim 3: Determine the optimal type, timing, and sequence of push notifications for encouraging daily mindfulness meditation within and across study groups. The efficacy of each push notification type (tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders), timing, and dynamics on the anchoring of daily meditation will inform a subsequent, just-in-time adaptive intervention (JITAI).
Impact: This study will inform an optimal JITAI R01 proposal that will personalize the type and temporal dynamics of app-based daily supports for successfully routinizing daily meditation, and determine its effects on mental health, specifically PTSD. Lifetime prevalence of PTSD is 7% in adults and meditation is known to reduce PTSD. If effective
Read the detailed description
Recruitment: Participants will be recruited for a "health and well-being" study starting July, 2020. Interested participants will be directed to a Qualtrics link to complete an online eligibility screener. The screener will take approximately 3 minutes to complete (See Eligibility Survey). The survey will be free, voluntary, and available online. Participants will be allowed to skip questions in the survey.
Eligibility: Once eligibility is determined, eligible participants will be sent an informed consent. Ineligible participants will be sent an email notifying their status and why. Once an informed consent is signed and received, the participant will be notified of their random assignment and study start date. Participants will be randomized via an online randomizer (i.e., randomizer.com) to either the Anchor Group (intervention) or the control group.
Enrollment: The Research Team will email the participants instructions to download Calm (See Participant Scripts). On their study start date the participant will be sent their baseline questionnaires via a Qualtrics link. The measures will be online and should take approximately 20 minutes to complete (See Baseline Questionnaires).
Intervention: The study will run for 8-weeks. Intervention participants will receive access to the mobile application Calm and be recommended to participate in the meditation features. Each participant will receive push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. The control group will receive access to the mobile application Calm and be recommended to participate in the meditation features but will not be asked to watch the anchoring strategy video. The control group will also receive push notification reminders however, they will not be anchor strategy specific (See Push Notifications).
Tracking: Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question each evening (see Study Questionnaires).
Post-study: Post-study questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from Qualtrics (See Post-study questionnaires). The post-intervention surveys will be online and take about 20 minutes and the satisfaction survey will take about 5 minutes.
Follow up: Participants will receive a follow up survey to complete via Qualtrics at 16 weeks. Follow up questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from Qualtrics. The follow up surveys will be online and take about 20 minutes and the satisfaction survey will take about 5 minutes. The follow up surveys will be identical to the post-study questionnaires.
- Being tested
- Personalized Anchoring Strategy, Non-Anchoring Strategy Control, Fixed Anchoring Strategy
- Medical subject headings
- Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Anchoring StrategyBehavioural
Also called Personalized Cue
The study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders.
Participants will be asked to choose a cue to use as an anchoring strategy. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm).
Non-Anchoring Strategy ControlBehavioural
The study will run for 8 weeks. Control participants will participate in the meditation features in their Calm account. Each participant will receive non-anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The control group will not be provided an anchoring strategy video on the persistence of daily meditation practice and receive non-anchoring strategy specific push notification study reminders. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm).
Fixed Anchoring StrategyBehavioural
Also called Fixed Cue
The study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. Participants will be asked to use a cue given by the research team. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm).
| Study group | Role | What they receive |
|---|---|---|
| Personalized Cue | Experimental | Participants in the intervention group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Participants will be asked to select a cue to use to remember to meditate. Receives: Behavioral: Personalized Anchoring Strategy |
| Study control | Active comparator | Participants in the control group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive non-anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Receives: Behavioral: Non-Anchoring Strategy Control |
| Fixed Cue | Experimental | Participants in the intervention group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Participants will be given a specific cue (i.e. leaving the bathroom in the morning) to use to remember to meditate. Receives: Behavioral: Fixed Anchoring Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of daily meditation
Persistence of daily meditation will be measured using objective app usage data provided by the Calm app informatics. Data will be on daily meditation minutes and an indicator for any daily meditation. We will measure change in persistence in daily meditation throughout the study.
Measured: Change measured over study (8 weeks) and follow up (16 weeks) periods.
Secondary outcomes (9)
Stress
Stress will be measured using the Perceived Stress Scale -10 item, with scores ranging from 10-40) and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Anxiety
Anxiety will be measured using the Hospital Anxiety and Depression Scale, with scores ranging from 0-21, and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Depression
Depression will be measured using the Hospital Anxiety and Depression Scale, with scores ranging from 0-21, and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Global Health
Global health will be measured using the PROMIS Global Health Scale v1.2, with scores ranging from 4-20, and higher scores indicate a better outcome.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
PTSD
PTSD will be measured using the Impact of Events Scale-Revised, with scores ranging from 0-88, with higher scores indicating a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Emotional Regulation
Emotional regulation will be measured using the Difficulties in Emotional Regulation -18, with scores ranging from 18-90, with higher scores indicating a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
HABIT
Habit will be measured using the habit questionnaire scored is the sum across the four questions (which are individually scored from 1-5 based on degree of agreement), where a higher score indicates more behavioral automaticity (strong habit).
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
COVID-19
COVID-19 as a mediator to the other health and well-being measures will be measured through a COVID-19 questionnaire created by the researcher. The items are scored from 1-5 with higher scores indicating COVID as a more significant mediator.
Measured: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Feasibility: Acceptability
Acceptability will be measured using a satisfaction survey at the end of the study, following all other measures (satisfied with the intervention and perceive daily meditation and app components as appropriate and useful)
Measured: Measured at post-intervention about experience in study (8 weeks) and follow up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start27 Jul 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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 StressStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Stecher, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378530
- Sponsor's protocol ID
- STUDY00011788
- Status last verified
- Jul 2022
- First submitted
- 13 Apr 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stecher C, Sullivan M, Huberty J. Using Personalized Anchors to Establish Routine Meditation Practice With a Mobile App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 22;9(12):e32794. doi: 10.2196/32794.
PubMed 34941558
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Takes Practice: mHealth Tools for Building Persistent Mindfulness Meditation Habits
- ClinicalTrials.gov ID
- NCT04378530
- Acronym / sponsor ID
- STUDY00011788
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 7 May 2020 (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.
The purpose of the study is to optimize the delivery of mHealth tools to support the formation of persistent mindfulness meditation routines.
Aim 1: Identify the efficacy of the anchoring strategy on the persistence of daily meditation practice.
H1: Persistence (measured through repeated observations of panel regression models of the daily likelihood of mindfulness mediation over the 16-week follow-up period) will be greater among AG as compared to CG.
Aim 2: Determine participant phenotypes that are (a) associated with successfully anchoring daily meditation or (b) likely to need additional supports. Potential moderators of the anchoring strategy's success include participants' daily schedule, type of work, household composition, motivation, time and risk preferences, and prior exposure to mindfulness, which will be analyzed in the panel regression model framework above.
Aim 3: Determine the optimal type, timing, and sequence of push notifications for encouraging daily mindfulness meditation within and across study groups. The efficacy of each push notification type (tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders), timing, and dynamics on the anchoring of daily meditation will inform a subsequent, just-in-time adaptive intervention (JITAI).
Impact: This study will inform an optimal JITAI R01 proposal that will personalize the type and temporal dynamics of app-based daily supports for successfully routinizing daily meditation, and determine its effects on mental health, specifically PTSD. Lifetime prevalence of PTSD is 7% in adults and meditation is known to reduce PTSD. If effective
Detailed description
Recruitment: Participants will be recruited for a "health and well-being" study starting July, 2020. Interested participants will be directed to a Qualtrics link to complete an online eligibility screener. The screener will take approximately 3 minutes to complete (See Eligibility Survey). The survey will be free, voluntary, and available online. Participants will be allowed to skip questions in the survey.
Eligibility: Once eligibility is determined, eligible participants will be sent an informed consent. Ineligible participants will be sent an email notifying their status and why. Once an informed consent is signed and received, the participant will be notified of their random assignment and study start date. Participants will be randomized via an online randomizer (i.e., randomizer.com) to either the Anchor Group (intervention) or the control group.
Enrollment: The Research Team will email the participants instructions to download Calm (See Participant Scripts). On their study start date the participant will be sent their baseline questionnaires via a Qualtrics link. The measures will be online and should take approximately 20 minutes to complete (See Baseline Questionnaires).
Intervention: The study will run for 8-weeks. Intervention participants will receive access to the mobile application Calm and be recommended to participate in the meditation features. Each participant will receive push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. The control group will receive access to the mobile application Calm and be recommended to participate in the meditation features but will not be asked to watch the anchoring strategy video. The control group will also receive push notification reminders however, they will not be anchor strategy specific (See Push Notifications).
Tracking: Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question each evening (see Study Questionnaires).
Post-study: Post-study questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from Qualtrics (See Post-study questionnaires). The post-intervention surveys will be online and take about 20 minutes and the satisfaction survey will take about 5 minutes.
Follow up: Participants will receive a follow up survey to complete via Qualtrics at 16 weeks. Follow up questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from Qualtrics. The follow up surveys will be online and take about 20 minutes and the satisfaction survey will take about 5 minutes. The follow up surveys will be identical to the post-study questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Cue | Experimental | Behavioral: Personalized Anchoring StrategyParticipants in the intervention group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Participants will be asked to select a cue to use to remember to meditate. |
| Study control | Active comparator | Behavioral: Non-Anchoring Strategy ControlParticipants in the control group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive non-anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. |
| Fixed Cue | Experimental | Behavioral: Fixed Anchoring StrategyParticipants in the intervention group will be recommended to participate in at least 10 minutes per day of meditation via a smartphone application for 8 weeks. Participants will receive anchoring specific push notifications and will respond to one, multiple-choice EMA (ecological momentary assessment) question 1x per day. Participants will be given a specific cue (i.e. leaving the bathroom in the morning) to use to remember to meditate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men or Women
- Between 18 and 60 years of age
- Able to read/understand English
- Have access to a smartphone on a daily basis
- Reside in the US or a US territory
Key exclusion criteria (4 listed)
- Currently using the Calm app or another meditation app
- Currently participating in >60 mins of meditation/yoga in one month within the last 6 months.
- Currently reside outside the United States
- Email provided is not associated with Calm account
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 |
|---|---|---|
| Personalized Anchoring StrategyAlso: Personalized CueThe study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. Participants will be asked to choose a cue to use as an anchoring strategy. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm). | Behavioural | Personalized Cue |
| Non-Anchoring Strategy ControlThe study will run for 8 weeks. Control participants will participate in the meditation features in their Calm account. Each participant will receive non-anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The control group will not be provided an anchoring strategy video on the persistence of daily meditation practice and receive non-anchoring strategy specific push notification study reminders. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm). | Behavioural | Study control |
| Fixed Anchoring StrategyAlso: Fixed CueThe study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. Participants will be asked to use a cue given by the research team. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm). | Behavioural | Fixed Cue |
Primary outcome
Persistence of daily meditation
Time frame: Change measured over study (8 weeks) and follow up (16 weeks) periods.
Persistence of daily meditation will be measured using objective app usage data provided by the Calm app informatics. Data will be on daily meditation minutes and an indicator for any daily meditation. We will measure change in persistence in daily meditation throughout the study.
9 secondary outcomes
Stress
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Anxiety
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Depression
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Global Health
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
PTSD
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Emotional Regulation
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
HABIT
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
COVID-19
Time frame: Change from baseline (week 0) to post-intervention (week 8) to follow up (week 16)
Feasibility: Acceptability
Time frame: Measured at post-intervention about experience in study (8 weeks) and follow up (16 weeks)
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 19 Jul 2022.
- Derived from this study: PubMed 34941558Stecher C, Sullivan M, Huberty J. Using Personalized Anchors to Establish Routine Meditation Practice With a Mobile App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 22;9(12):e32794. doi: 10.2196/32794.
- Individual participant dataSharing planned: No
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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.
Chad Stecher, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Anchoring Strategy and Fixed Anchoring Strategy in people with Stress and Habits, run by Arizona State University 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 4 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 19 Jul 2022. 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?
Persistence of daily meditation (time frame: Change measured over study (8 weeks) and follow up (16 weeks) periods.). 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 NCT04378530, 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 19 Jul 2022.