Targeting Worry to Improve Sleep
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Jul 2019
Shorter than P25 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2020
CompletedResults Posted
Study results publicly available
October 10, 2022
CompletedOctober 10, 2022
September 1, 2022
7 months
September 24, 2018
July 21, 2022
September 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Worry
Baseline, 2 months
Change in Total Sleep Time (TST)
Baseline, 2 months
Changes in Non-reactivity
Baseline, 2 months
Study Arms (2)
TAU + App-Delivered Mindfulness Training (MT)
EXPERIMENTALThe 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)
OTHERIndividuals 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)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Brown University
Providence, Rhode Island, 02903, United States
Related Publications (1)
Gao M, Roy A, Deluty A, Sharkey KM, Hoge EA, Liu T, Brewer JA. Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training. Psychosom Med. 2022 Jun 1;84(5):632-642. doi: 10.1097/PSY.0000000000001083. Epub 2022 Apr 14.
PMID: 35420589DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Judson Brewer
- Organization
- Brown University
Study Officials
- PRINCIPAL INVESTIGATOR
Judson Brewer, MD, PhD
Brown University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2018
First Posted
September 25, 2018
Study Start
July 25, 2019
Primary Completion
February 26, 2020
Study Completion
February 26, 2020
Last Updated
October 10, 2022
Results First Posted
October 10, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share