Targeting Worry to Improve Sleep

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
TAU + App-Delivered Mindfulness Training (MT)	App-Delivered Mindfulness Training (MT)	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.
Treatment as Usual (TAU)	App-Delivered Mindfulness Training (MT)	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)

Primary Outcome Measures

Name	Time	Method
Change in Worry-related Sleep Disturbances	Baseline, 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Non-reactivity	Baseline, 2 months	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.
Change in Worry	Baseline, 2 months	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
Change in Total Sleep Time (TST)	Baseline, 2 months	A Fitbit will be used to assess sleep trends over a 1 week period