The purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.
In this study, 80 individuals with worry interfering with sleep will be randomized to receive Unwinding Anxiety or to Treatment as Usual (50/50 chance). The active intervention period will last 2 months, with an optional 2-month follow-up period in which the intervention remains available. Changes in mindfulness, emotional reactivity, cognition and sleep behavior at specified time points will be measured. The primary engagement targets will be non-reactivity and worry. The primary behavioral outcome target will be sleep.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Unwinding Anxiety is an app-delivered mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (\~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on the self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time
Brown University
Providence, Rhode Island, United States
Change in Worry-related Sleep Disturbances
5 questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) pertaining to anxiety and sleep will be used to assess worry-related sleep disturbances over the past 7 days. These questions are on a 5-point Likert scale where 1 is "Not at all" and 5 is "Very much". Scores can range from 5 to 25 and higher scores indicate a worse outcome.
Time frame: Baseline, 2 months
Change in Worry
Penn State Worry Questionnaire (PSWQ) will be used to assess worry. The PSWQ is a 16-item questionnaire that uses a 5-point Likert scale where 1 is "Not at all typical of me" and 5 is "Very typical of me". Scores can range from 16 to 80 and higher scores indicate a worse outcome
Time frame: Baseline, 2 months
Change in Total Sleep Time (TST)
A Fitbit will be used to assess sleep trends over a 1 week period
Time frame: Baseline, 2 months
Changes in Non-reactivity
Non-reactivity subscale from the 15-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measure changes in emotional reactivity. This subscale is based on responses to 3 questions measured on a 5-point Likert scale where 1 is "Never or rarely" and 5 is "Very often or always true". Scores can range from 3 to 15 and higher scores indicate a better outcome.
Time frame: Baseline, 2 months
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