Anxiety, Sleep Disturbance
Conditions
Keywords
Worry
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.
Detailed 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.
Interventions
BEHAVIORALApp-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
Sponsors
National Institute on Aging (NIA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Worry-related Sleep Disturbances | Baseline, 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Worry | Baseline, 2 months | 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 |
| Change in Total Sleep Time (TST) | Baseline, 2 months | A Fitbit will be used to assess sleep trends over a 1 week period |
| Changes in Non-reactivity | Baseline, 2 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAU + 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 | 36 |
| 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 | 35 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Treatment as Usual (TAU) | Total | TAU + App-Delivered Mindfulness Training (MT) |
|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 16.8 | 41 years STANDARD_DEVIATION 18 | 42.2 years STANDARD_DEVIATION 18.5 |
| Highest level of education completed Associate's degree | 3 Participants | 5 Participants | 2 Participants |
| Highest level of education completed Bachelor's degree | 8 Participants | 19 Participants | 11 Participants |
| Highest level of education completed Graduate degree | 16 Participants | 33 Participants | 17 Participants |
| Highest level of education completed High school or GED | 0 Participants | 2 Participants | 2 Participants |
| Highest level of education completed Some college | 8 Participants | 12 Participants | 4 Participants |
| Income ≥$100,000 | 10 Participants | 22 Participants | 12 Participants |
| Income <$15,000-$44,999 | 6 Participants | 15 Participants | 9 Participants |
| Income $45,000-$99,999 | 9 Participants | 21 Participants | 12 Participants |
| Income Prefer not to answer | 10 Participants | 13 Participants | 3 Participants |
| Marital status Married | 16 Participants | 25 Participants | 9 Participants |
| Marital status Never married | 16 Participants | 33 Participants | 17 Participants |
| Marital status Separated/divorced | 2 Participants | 9 Participants | 7 Participants |
| Marital status Widowed | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized ≥2 races | 4 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic, Latinx, Spanish | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 23 Participants | 44 Participants | 21 Participants |
| Sex/Gender, Customized Female | 32 Participants | 57 Participants | 25 Participants |
| Sex/Gender, Customized Male | 3 Participants | 12 Participants | 9 Participants |
| Sex/Gender, Customized Prefer not to answer | 0 Participants | 2 Participants | 2 Participants |
| Work status Employed full-time | 22 Participants | 41 Participants | 19 Participants |
| Work status Employed part-time | 6 Participants | 18 Participants | 12 Participants |
| Work status Homemaker | 0 Participants | 1 Participants | 1 Participants |
| Work status Retired | 3 Participants | 5 Participants | 2 Participants |
| Work status Unemployed | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 0 / 36 | 0 / 35 |
| serious Total, serious adverse events | 0 / 36 | 0 / 35 |
Outcome results
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.
Time frame: Baseline, 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAU + App-Delivered Mindfulness Training (MT) | Change in Worry-related Sleep Disturbances | -4 units on a scale |
| Treatment as Usual (TAU) | Change in Worry-related Sleep Disturbances | -1 units on a scale |
Secondary
Change in Total Sleep Time (TST)
A Fitbit will be used to assess sleep trends over a 1 week period
Time frame: Baseline, 2 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAU + App-Delivered Mindfulness Training (MT) | Change in Total Sleep Time (TST) | 9 minutes |
| Treatment as Usual (TAU) | Change in Total Sleep Time (TST) | 3 minutes |
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
Time frame: Baseline, 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAU + App-Delivered Mindfulness Training (MT) | Change in Worry | -9 units on a scale |
| Treatment as Usual (TAU) | Change in Worry | 0.0 units on a scale |
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.
Time frame: Baseline, 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAU + App-Delivered Mindfulness Training (MT) | Changes in Non-reactivity | 4.5 units on a scale |
| Treatment as Usual (TAU) | Changes in Non-reactivity | 0 units on a scale |