Clinical trial NCT03783793: Effects of a Mindfulness Meditation App on Subjective Well-Being in Undergraduate University Students
Official title: Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: mindfulness
attention
mobile health
interoception
mood
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ontario centre for excellence vip program
First posted: 2018-12-21
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* Normal or corrected-to-normal vision and hearing
* Be fluent in english
* Own an iPhone, iPad, or iPod with access to the internet

Primary outcomes:
measure: Change on the Perceived Stress Scale
timeFrame: 0 weeks and 3 weeks
measure: Change on the Big Five Inventory
timeFrame: 0 weeks and 3 weeks
measure: Change on the Psychological Well-Being Scale
timeFrame: 0 weeks and 3 weeks
measure: Change on the Acceptance and Action Questionnaire-II
timeFrame: 0 weeks and 3 weeks
measure: Change on the Philadelphia Mindfulness Scale
timeFrame: 0 weeks and 3 weeks
measure: Change on the Multidimensional Assessment of Interoceptive Awareness
timeFrame: 0 weeks and 3 weeks
measure: Change on the Spiritual Experience Index-Revised
timeFrame: 0 weeks and 3 weeks
measure: Change on the Meaning in Life Questionnaire
timeFrame: 0 weeks and 3 weeks
measure: Change on the Mood Board Circumplex
timeFrame: 0 weeks and 3 weeks
measure: Change on the Centre for Research on Safe Driving-Attention Network Test
timeFrame: 0 weeks and 3 weeks
measure: Change on the Respiration Integration Task
timeFrame: 0 weeks and 3 weeks
measure: Change in Mood
timeFrame: 0 minutes and approximately 10 minutes, every day for 3 weeks.
measure: Change in Stress
timeFrame: 0 minutes and approximately 10 minutes, every day for 3 weeks.
measure: Change in Heart Rate
timeFrame: 0 minutes and approximately 10 minutes, every day for 3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.