Trial Outcomes & Findings for Targeting Worry to Improve Sleep (NCT NCT03684057)
NCT ID: NCT03684057
Last Updated: 2022-10-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, 2 months
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
TAU and 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
|
Treatment as Usual (TAU)
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
TAU and 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
|
Treatment as Usual (TAU)
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
Targeting Worry to Improve Sleep
Baseline characteristics by cohort
| Measure |
TAU + App-Delivered Mindfulness Training (MT)
n=36 Participants
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
|
Treatment as Usual (TAU)
n=35 Participants
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 18.5 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
41 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latinx, Spanish
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
≥2 races
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Highest level of education completed
High school or GED
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Highest level of education completed
Some college
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Highest level of education completed
Associate's degree
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Highest level of education completed
Bachelor's degree
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Highest level of education completed
Graduate degree
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Work status
Employed full-time
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Work status
Employed part-time
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Work status
Homemaker
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Work status
Retired
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Work status
Unemployed
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital status
Never married
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Marital status
Married
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Marital status
Separated/divorced
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital status
Widowed
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Income
<$15,000-$44,999
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Income
$45,000-$99,999
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Income
≥$100,000
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Income
Prefer not to answer
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 months5 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.
Outcome measures
| Measure |
TAU + App-Delivered Mindfulness Training (MT)
n=36 Participants
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
|
Treatment as Usual (TAU)
n=35 Participants
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
|---|---|---|
|
Change in Worry-related Sleep Disturbances
|
-4 units on a scale
Interval -8.0 to -2.8
|
-1 units on a scale
Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPenn 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
Outcome measures
| Measure |
TAU + App-Delivered Mindfulness Training (MT)
n=36 Participants
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
|
Treatment as Usual (TAU)
n=35 Participants
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
|---|---|---|
|
Change in Worry
|
-9 units on a scale
Interval -12.2 to -1.0
|
0.0 units on a scale
Interval -4.0 to 2.5
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: Fitbit data was not available for both wear periods (due to a failure to wear and/or technical issues) for 11 participants in the TAU + MT group and for 14 participants in the TAU group.
A Fitbit will be used to assess sleep trends over a 1 week period
Outcome measures
| Measure |
TAU + App-Delivered Mindfulness Training (MT)
n=25 Participants
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
|
Treatment as Usual (TAU)
n=21 Participants
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
|---|---|---|
|
Change in Total Sleep Time (TST)
|
9 minutes
Interval -28.0 to 34.0
|
3 minutes
Interval -21.0 to 37.0
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsNon-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.
Outcome measures
| Measure |
TAU + App-Delivered Mindfulness Training (MT)
n=36 Participants
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
|
Treatment as Usual (TAU)
n=35 Participants
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)
App-based mindfulness training: Unwinding Anxiety is an app-based 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
|
|---|---|---|
|
Changes in Non-reactivity
|
4.5 units on a scale
Interval 1.0 to 6.0
|
0 units on a scale
Interval -2.0 to 2.5
|
Adverse Events
TAU and App-delivered Mindfulness Training (MT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place