Stress, PsychologicalNCT03783793
Effects of a Mindfulness Meditation App on Subjective Well-Being in Undergraduate University Students
A study testing Mindfulness Training App and Cognitive Training With 2048 in people with Stress, Psychological, run by University of Toronto.
Trial summary
Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Mindfulness Training App and Cognitive Training With 2048
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2016to 5 May 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal or corrected-to-normal vision and hearing
- Be fluent in english
- Own an iPhone, iPad, or iPod with access to the internet
Who cannot join
None listed.
About this study
Official title: Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study
Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. This study aimed to investigate a newly developed mindfulness training app called Wildflowers, which was co-developed with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of mindfulness training through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.
Read the detailed description
Background: Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. This study aimed to investigate a newly developed mindfulness training app called Wildflowers, which was co-developed with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of mindfulness training through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.
Methods: Undergraduate students completed 3 weeks of mindfulness training with Wildflowers or 3 weeks of cognitive training with a game called 2048. State training effects were assessed through pre- and postsession ratings of current mood, stress level, and heart rate. Trait training effects were assessed through pre- and postintervention questionnaires canvassing subjective well-being and behavioral task measures of attentional control and interoceptive integration. State and trait training data were analyzed in a multilevel model using emergent latent factors (acceptance, awareness, and openness) to summarize the trait questionnaire battery.
- Conditions
- Stress, Psychological
- Being tested
- Mindfulness Training App, Cognitive Training With 2048
- Keywords
- mindfulness, attention, mobile health, interoception, mood
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training AppBehavioural
Mindfulness training in the study was performed using a new app called Wildflowers. With this app participants were able to choose and complete a variety of guided meditations over the 3 week training period. Wildflowers includes guided meditations such as breathing, body scans, and open monitoring practices and also provides didactic content in the form of lessons and information about the benefits of mindfulness training.
Cognitive Training With 2048Behavioural
The training app for the control condition was based on an open source code for a popular cognitive training app called 2048 that is marketed as a fun and relaxing puzzle game. Within 2048, participants slide numbered tiles around a grid, matching tiles of the same value. Instead of tiles disappearing, as in Candy Crush or other similar grid-sliding games, matching 2 numbered tiles in 2048 combines them into 1 new tile displaying the sum of the previous 2 numbers. For example, two 2-tiles linked side-by-side become a 4-tile, whereas 2 matched 4-tiles become an 8-tile, and so on. The goal is to match tiles until the sum of 2048 is reached on a single tile. There is no time limit.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training App | Experimental | Not described Receives: Behavioral: Mindfulness Training App |
| Cognitive Training With 2048 | Active comparator | Not described Receives: Behavioral: Cognitive Training With 2048 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Perceived Stress Scale
A 4-item self-report scale that measures the global perception of stress. The scale asks participants about their feelings and thoughts during the last month, and participants indicate on a 5-point Likert scale how often they thought or felt a certain way, with 0 being never and 4 being very often. A higher score on this measure represents higher levels of self-reported stress (worse outcome) with a minimum possible score of 0 and a maximum of 16.
Measured: 0 weeks and 3 weeks
Change on the Big Five Inventory
A 44-item self-report scale that measures the 5 dimensions of personality: extraversion, agreeableness, conscientiousness, neuroticism, and openness. On this scale, participants are asked if different characteristics apply to them. For each characteristic queried participants respond on a 5-point Likert scale, with 1 being disagree strongly and 5 being agree strongly. This scale yields 5 scores, one for each of the subscales: extraversion (min-max range: 8-40), agreeableness (min-max range: 9-45), conscientiousness (min-max range: 9-45), neuroticism (min-max range: 8-40), and openness (min-max range: 10-50). Higher values on each of the subscales represent higher levels of that particular personality trait.
Measured: 0 weeks and 3 weeks
Change on the Psychological Well-Being Scale
An 84-item self-report questionnaire that measures psychological well-being. Respondents rate statements on a 6-point likert scale, with 1 being strong disagreement and 6 being strong agreement. This measure yields 6 scores, one for each subscale: autonomy, self-acceptance, positive relations with others, environmental mastery, purpose in life, and personal growth. Each of these subscales have a possible minimum score of 14 and a maximum score of 84 with higher values representing a better outcome.
Measured: 0 weeks and 3 weeks
Change on the Acceptance and Action Questionnaire-II
A 7-item self-report scale that measures psychological inflexibility and experiential avoidance. Respondents rate a list of statements on a 7-point likert scale, with 1 being never true and 7 being always true. This measure yields one score with a possible minimum of 7 and a maximum of 49. Higher values represent greater levels of psychological inflexibility (worse outcome).
Measured: 0 weeks and 3 weeks
Change on the Philadelphia Mindfulness Scale
A 20-item self-report scale that measures 2 components of mindfulness: awareness and acceptance. Respondents rate a series of statements on a 5-point likert scale, with 1 being never and 5 being very often. This scale yields two scores, one for each subscale: awareness and acceptance. On the awareness scale the minimum possible score is 10 and the maximum is 50. Higher values on this subscale represent higher levels of awareness (better outcome). For the acceptance subscale, the minimum possible score is 10 and the maximum is 50, with higher values representing higher levels of acceptance (better outcome).
Measured: 0 weeks and 3 weeks
Change on the Multidimensional Assessment of Interoceptive Awareness
A 32-item self-report scale that measures the multidimensional construct of interoceptive body awareness. Respondents rate a list of statements on a 6-point likert scale, with 0 being never and 5 being always. This measure yields 8 scores, one for each of the subscales: noticing (min-max range: 0-20), not distracting (min-max range: 0-15), not worrying (min-max range: 0-15), attention regulation (min-max range: 0-35), emotional awareness (min-max range: 0-25), self-regulation (min-max range: 0-20), body listening (min-max range: 0-15), and trusting (min-max range: 0-15). On each of these subscales, higher values represent higher levels of interoceptive body awareness (better outcome).
Measured: 0 weeks and 3 weeks
Change on the Spiritual Experience Index-Revised
A 23-item self-report scale that measures a person's faith and spiritual journey. Respondents rate a list of statements on a 6-point likert scale, with 1 being strongly disagree and 6 being strongly agree. This measure yields two scores, one for each subscale: spiritual support (min-max range: 13-78) and spiritual openness (min-max range: 10-60). On the spiritual support subscale, higher values represent higher levels of spiritual support (better outcome). On the spiritual openness subscale, higher values represent higher levels of spiritual openness (better outcome).
Measured: 0 weeks and 3 weeks
Change on the Meaning in Life Questionnaire
A 10-item self-report scale that measures 2 dimensions of the meaning in life and as such includes 2 subscales: presence of meaning and search for meaning. Respondents rate statements on a 7-point Likert scale, with 1 being absolutely untrue and 7 being absolutely true. On the presence of meaning subscale the minimum possible score is 5 and the maximum is 35, with higher values representing the degree that participants feel they have meaning in their lives (better outcome). On the search for meaning subscale the minimum possible score is 5 and the maximum is 35, with higher values representing the extent that individuals are searching for meaning in their lives (better outcome).
Measured: 0 weeks and 3 weeks
Change on the Mood Board Circumplex
The mood board is a visual representation of negative and positive emotions on a spectrum, ranging from intense emotions to mild emotions. This mood board provides a maximum of 32 emotions that a participant can select by clicking on that emotion. This measure yields 4 scores one for each subscale. Each subscale has a minimum possible score of 0 and maximum of 8. Higher values on the intense negative emotions subscale represent greater levels of intense negative emotions (worse outcome). Higher values on the intense positive emotions subscale represents greater levels of intense positive emotions (better outcome). Higher values on the mild negative emotions subscale represents greater levels of mild negative emotions (worse outcome). Lastly, higher values on the mild positive emotions subscale represents greater levels of mild positive emotions (better outcome).
Measured: 0 weeks and 3 weeks
Change on the Centre for Research on Safe Driving-Attention Network Test
This is a 10-min version of the Attention Network Test that measures 3 different functions of attention:
alerting, orienting, and conflict monitoring.
Measured: 0 weeks and 3 weeks
Change on the Respiration Integration Task
This is a newly developed behavioral task created in our laboratory to assess interoceptive attention.
Measured: 0 weeks and 3 weeks
Change in Mood
Mood was measured via self-report on the smartphone app. This measurement was taken before and after each use of the smartphone app in their assigned condition.
Measured: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Change in Stress
Stress was measured using a visual analogue scale on a smartphone app where participants would rate their level of stress by sliding a bar along the scale. They would slide the bar to the green side of the scale if experiencing low levels of stress and to the red side of the scale if experiencing high levels of stress. This is a continuous scale with a minimum possible score of 0 and a maximum score of 1, with higher values representing greater levels of stress (worse outcome). This measurement was taken before and after each use of the smartphone app in their assigned condition.
Measured: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Change in Heart Rate
Heart rate was measured using the camera on the smartphone app using a well established algorithm. This measurement was taken before and after each use of the smartphone app in their assigned condition.
Measured: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start5 May 2016
- Primary completion5 May 2017
- Study completion5 May 2017
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 Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario centre for excellence vip program
- Responsible party
- Principal investigator, Norman Farb, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783793
- Sponsor's protocol ID
- 32099
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walsh KM, Saab BJ, Farb NA. Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study. JMIR Ment Health. 2019 Jan 8;6(1):e10844. doi: 10.2196/10844.
PubMed 30622094
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study
- ClinicalTrials.gov ID
- NCT03783793
- Acronym / sponsor ID
- 32099
- Conditions
- Stress, Psychological
- Keywords
- mindfulness, attention, mobile health, interoception, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario centre for excellence vip program
- Study start
- 5 May 2016 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 21 Dec 2018 (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.
Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. This study aimed to investigate a newly developed mindfulness training app called Wildflowers, which was co-developed with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of mindfulness training through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.
Detailed description
Background: Mindfulness training includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of non-judgment and curiosity. Following the success of 8-week, manualized group interventions, mindfulness training has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. This study aimed to investigate a newly developed mindfulness training app called Wildflowers, which was co-developed with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of mindfulness training through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.
Methods: Undergraduate students completed 3 weeks of mindfulness training with Wildflowers or 3 weeks of cognitive training with a game called 2048. State training effects were assessed through pre- and postsession ratings of current mood, stress level, and heart rate. Trait training effects were assessed through pre- and postintervention questionnaires canvassing subjective well-being and behavioral task measures of attentional control and interoceptive integration. State and trait training data were analyzed in a multilevel model using emergent latent factors (acceptance, awareness, and openness) to summarize the trait questionnaire battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training App | Experimental | Behavioral: Mindfulness Training App |
| Cognitive Training With 2048 | Active comparator | Behavioral: Cognitive Training With 2048 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal or corrected-to-normal vision and hearing
- Be fluent in english
- Own an iPhone, iPad, or iPod with access to the internet
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mindfulness Training AppMindfulness training in the study was performed using a new app called Wildflowers. With this app participants were able to choose and complete a variety of guided meditations over the 3 week training period. Wildflowers includes guided meditations such as breathing, body scans, and open monitoring practices and also provides didactic content in the form of lessons and information about the benefits of mindfulness training. | Behavioural | Mindfulness Training App |
| Cognitive Training With 2048The training app for the control condition was based on an open source code for a popular cognitive training app called 2048 that is marketed as a fun and relaxing puzzle game. Within 2048, participants slide numbered tiles around a grid, matching tiles of the same value. Instead of tiles disappearing, as in Candy Crush or other similar grid-sliding games, matching 2 numbered tiles in 2048 combines them into 1 new tile displaying the sum of the previous 2 numbers. For example, two 2-tiles linked side-by-side become a 4-tile, whereas 2 matched 4-tiles become an 8-tile, and so on. The goal is to match tiles until the sum of 2048 is reached on a single tile. There is no time limit. | Behavioural | Cognitive Training With 2048 |
Primary outcome
Change on the Perceived Stress Scale
Time frame: 0 weeks and 3 weeks
A 4-item self-report scale that measures the global perception of stress. The scale asks participants about their feelings and thoughts during the last month, and participants indicate on a 5-point Likert scale how often they thought or felt a certain way, with 0 being never and 4 being very often. A higher score on this measure represents higher levels of self-reported stress (worse outcome) with a minimum possible score of 0 and a maximum of 16.
Change on the Big Five Inventory
Time frame: 0 weeks and 3 weeks
A 44-item self-report scale that measures the 5 dimensions of personality: extraversion, agreeableness, conscientiousness, neuroticism, and openness. On this scale, participants are asked if different characteristics apply to them. For each characteristic queried participants respond on a 5-point Likert scale, with 1 being disagree strongly and 5 being agree strongly. This scale yields 5 scores, one for each of the subscales: extraversion (min-max range: 8-40), agreeableness (min-max range: 9-45), conscientiousness (min-max range: 9-45), neuroticism (min-max range: 8-40), and openness (min-max range: 10-50). Higher values on each of the subscales represent higher levels of that particular personality trait.
Change on the Psychological Well-Being Scale
Time frame: 0 weeks and 3 weeks
An 84-item self-report questionnaire that measures psychological well-being. Respondents rate statements on a 6-point likert scale, with 1 being strong disagreement and 6 being strong agreement. This measure yields 6 scores, one for each subscale: autonomy, self-acceptance, positive relations with others, environmental mastery, purpose in life, and personal growth. Each of these subscales have a possible minimum score of 14 and a maximum score of 84 with higher values representing a better outcome.
Change on the Acceptance and Action Questionnaire-II
Time frame: 0 weeks and 3 weeks
A 7-item self-report scale that measures psychological inflexibility and experiential avoidance. Respondents rate a list of statements on a 7-point likert scale, with 1 being never true and 7 being always true. This measure yields one score with a possible minimum of 7 and a maximum of 49. Higher values represent greater levels of psychological inflexibility (worse outcome).
Change on the Philadelphia Mindfulness Scale
Time frame: 0 weeks and 3 weeks
A 20-item self-report scale that measures 2 components of mindfulness: awareness and acceptance. Respondents rate a series of statements on a 5-point likert scale, with 1 being never and 5 being very often. This scale yields two scores, one for each subscale: awareness and acceptance. On the awareness scale the minimum possible score is 10 and the maximum is 50. Higher values on this subscale represent higher levels of awareness (better outcome). For the acceptance subscale, the minimum possible score is 10 and the maximum is 50, with higher values representing higher levels of acceptance (better outcome).
Change on the Multidimensional Assessment of Interoceptive Awareness
Time frame: 0 weeks and 3 weeks
A 32-item self-report scale that measures the multidimensional construct of interoceptive body awareness. Respondents rate a list of statements on a 6-point likert scale, with 0 being never and 5 being always. This measure yields 8 scores, one for each of the subscales: noticing (min-max range: 0-20), not distracting (min-max range: 0-15), not worrying (min-max range: 0-15), attention regulation (min-max range: 0-35), emotional awareness (min-max range: 0-25), self-regulation (min-max range: 0-20), body listening (min-max range: 0-15), and trusting (min-max range: 0-15). On each of these subscales, higher values represent higher levels of interoceptive body awareness (better outcome).
Change on the Spiritual Experience Index-Revised
Time frame: 0 weeks and 3 weeks
A 23-item self-report scale that measures a person's faith and spiritual journey. Respondents rate a list of statements on a 6-point likert scale, with 1 being strongly disagree and 6 being strongly agree. This measure yields two scores, one for each subscale: spiritual support (min-max range: 13-78) and spiritual openness (min-max range: 10-60). On the spiritual support subscale, higher values represent higher levels of spiritual support (better outcome). On the spiritual openness subscale, higher values represent higher levels of spiritual openness (better outcome).
Change on the Meaning in Life Questionnaire
Time frame: 0 weeks and 3 weeks
A 10-item self-report scale that measures 2 dimensions of the meaning in life and as such includes 2 subscales: presence of meaning and search for meaning. Respondents rate statements on a 7-point Likert scale, with 1 being absolutely untrue and 7 being absolutely true. On the presence of meaning subscale the minimum possible score is 5 and the maximum is 35, with higher values representing the degree that participants feel they have meaning in their lives (better outcome). On the search for meaning subscale the minimum possible score is 5 and the maximum is 35, with higher values representing the extent that individuals are searching for meaning in their lives (better outcome).
Change on the Mood Board Circumplex
Time frame: 0 weeks and 3 weeks
The mood board is a visual representation of negative and positive emotions on a spectrum, ranging from intense emotions to mild emotions. This mood board provides a maximum of 32 emotions that a participant can select by clicking on that emotion. This measure yields 4 scores one for each subscale. Each subscale has a minimum possible score of 0 and maximum of 8. Higher values on the intense negative emotions subscale represent greater levels of intense negative emotions (worse outcome). Higher values on the intense positive emotions subscale represents greater levels of intense positive emotions (better outcome). Higher values on the mild negative emotions subscale represents greater levels of mild negative emotions (worse outcome). Lastly, higher values on the mild positive emotions subscale represents greater levels of mild positive emotions (better outcome).
Change on the Centre for Research on Safe Driving-Attention Network Test
Time frame: 0 weeks and 3 weeks
This is a 10-min version of the Attention Network Test that measures 3 different functions of attention: alerting, orienting, and conflict monitoring.
Change on the Respiration Integration Task
Time frame: 0 weeks and 3 weeks
This is a newly developed behavioral task created in our laboratory to assess interoceptive attention.
Change in Mood
Time frame: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Mood was measured via self-report on the smartphone app. This measurement was taken before and after each use of the smartphone app in their assigned condition.
Change in Stress
Time frame: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Stress was measured using a visual analogue scale on a smartphone app where participants would rate their level of stress by sliding a bar along the scale. They would slide the bar to the green side of the scale if experiencing low levels of stress and to the red side of the scale if experiencing high levels of stress. This is a continuous scale with a minimum possible score of 0 and a maximum score of 1, with higher values representing greater levels of stress (worse outcome). This measurement was taken before and after each use of the smartphone app in their assigned condition.
Change in Heart Rate
Time frame: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Heart rate was measured using the camera on the smartphone app using a well established algorithm. This measurement was taken before and after each use of the smartphone app in their assigned condition.
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 Dec 2018.
- Derived from this study: PubMed 30622094Walsh KM, Saab BJ, Farb NA. Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study. JMIR Ment Health. 2019 Jan 8;6(1):e10844. doi: 10.2196/10844.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training App and Cognitive Training With 2048 in people with Stress, Psychological, run by University of Toronto.
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 3 inclusion and 0 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change on the Perceived Stress Scale (time frame: 0 weeks and 3 weeks). The study lists 14 primary outcomes in all. 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 NCT03783793, 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 Dec 2018.