N/A N=80 Randomized Single-blind Treatment

Targeting Worry to Improve Sleep

Anxiety · Sleep Disturbance

Bottom Line

View on ClinicalTrials.gov: NCT03684057 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Change in Worry-related Sleep Disturbances — -4; -1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: App-Delivered Mindfulness Training (MT) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brown University
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Worry-related Sleep Disturbances	-4; -1	—
SECONDARY Change in Worry	-9; 0.0	—
SECONDARY Change in Total Sleep Time (TST)	9; 3	—
SECONDARY Changes in Non-reactivity	4.5; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03684057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.