Targeting Worry to Improve Sleep

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeting Worry to Improve Sleep Using App-Based Mindfulness Training

Conditions
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Anxiety, Sleep Disturbance

Intervention / Treatment
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* Behavioral: App-Delivered Mindfulness Training (MT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score > 40 on the Penn State Worry Questionnaire (PSWQ) Score ≥ to 40% on Worry Interfering with Sleep Scale (WISS) Owns a smartphone Willing to wear a sleep tracker for at least 1 week Exclusion Criteria: Any usage of psychotropic medication: not on a stable dosage 6+ weeks Medical disorder of the severity that would interfere with ability to attend visits and complete study milestones Use of benzodiazepine or hypnotic sleep aid on as needed (i.e. prn) Known sleep disorder Psychotic disorder Post-traumatic Stress Disorder Severe depression (Score > 3 on PHQ-2) Current shift work employment BMI > 35 Evening caffeine use Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + App-Delivered Mindfulness Training (MT)<br>The Unwinding Anxiety program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment. | Behavioral: App-Delivered Mindfulness Training (MT)<br>* 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<br>|
| Other: Treatment as Usual (TAU)<br>Individuals in the TAU group will complete the assessments without an intervention. (Note: participants will be transitioned to the Unwinding Anxiety program following the 2-month wait list control period) | Behavioral: App-Delivered Mindfulness Training (MT)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 2 months | 
| Change in Total Sleep Time (TST) | A Fitbit will be used to assess sleep trends over a 1 week period | 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. | Baseline, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Worry