Targeting Worry to Improve Sleep



Status:Not yet recruiting
Conditions:Anxiety, Anxiety, Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:January 2019
End Date:May 2021
Contact:Judson Brewer, MD, PhD
Email:judson_brewer@brown.edu
Phone:401-863-2826

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Targeting Worry to Improve Sleep Using App-Based Mindfulness Training

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, 64 individuals with worry interfering with sleep will be randomized to receive
Unwinding Anxiety or to wait-list control (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.

Inclusion Criteria:

- Score > 40 on the Penn State Worry Questionnaire (PSWQ)

- Score ≥ to 50% 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 > 32 on PROMIS Emotional Distress - Depression)

- Current shift work employment

- Weight > 250 lbs

- Evening caffeine use

- Pregnant women
We found this trial at
1
site
69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Principal Investigator: Judson Brewer, MD, PhD
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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mi
from
Providence, RI
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