Targeting Worry to Improve Sleep

Anxiety Clinical Trial

Official title:

Targeting Worry to Improve Sleep Using App-Based Mindfulness Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684057
• Other study ID #: R21AG062004
• Secondary ID: R21AG062004
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: February 26, 2020

Study information

• Verified date: September 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• App-Delivered Mindfulness Training (MT)
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

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Worry	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	Baseline, 2 months
Secondary	Change in Total Sleep Time (TST)	A Fitbit will be used to assess sleep trends over a 1 week period	Baseline, 2 months
Secondary	Changes in Non-reactivity	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.	Baseline, 2 months