Targeting Worry to Improve Sleep

Brown University

Status: Completed

Conditions: Sleep Disturbance; Anxiety

Treatments: Behavioral: App-Delivered Mindfulness Training (MT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03684057

R21AG062004 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

TAU + App-Delivered Mindfulness Training (MT)

Experimental group

Description:

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:

Behavioral: App-Delivered Mindfulness Training (MT)

Treatment as Usual (TAU)

Other group

Description:

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)

Treatment:

Behavioral: App-Delivered Mindfulness Training (MT)