AnxietyNCT03684057
Targeting Worry to Improve Sleep
A study testing App-Delivered Mindfulness Training (MT) in people with Anxiety and Sleep Disturbance, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Sleep Disturbance
- What is being tested?
- App-Delivered Mindfulness Training (MT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Severe depression (Score > 3 on PHQ-2)
- Current shift work employment
- BMI > 35
- Evening caffeine use
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Worry to Improve Sleep Using App-Based Mindfulness Training
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.
Read the 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.
- Conditions
- Anxiety, Sleep Disturbance
- Being tested
- App-Delivered Mindfulness Training (MT)
- Keywords
- Worry
- Medical subject headings
- Anxiety Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-Delivered Mindfulness Training (MT)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| TAU + App-Delivered Mindfulness Training (MT) | Experimental | The 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. Receives: Behavioral: App-Delivered Mindfulness Training (MT) |
| Treatment as Usual (TAU) | Other | 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) Receives: Behavioral: App-Delivered Mindfulness Training (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 months
Secondary outcomes (3)
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
Measured: Baseline, 2 months
Change in Total Sleep Time (TST)
A Fitbit will be used to assess sleep trends over a 1 week period
Measured: Baseline, 2 months
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.
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start25 Jul 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Judson Brewer, MD, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684057
- Sponsor's protocol ID
- R21AG062004
- Other IDs
- R21AG062004
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2018
- Last updated
- 10 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35420589
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Worry to Improve Sleep Using App-Based Mindfulness Training
- ClinicalTrials.gov ID
- NCT03684057
- Acronym / sponsor ID
- R21AG062004
- Conditions
- Anxiety, Sleep Disturbance
- Keywords
- Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 10 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + App-Delivered Mindfulness Training (MT) | Experimental | Behavioral: App-Delivered Mindfulness Training (MT)The 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) | Other | Behavioral: App-Delivered Mindfulness Training (MT)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | TAU + App-Delivered Mindfulness Training (MT), Treatment as Usual (TAU) |
Primary outcome
Change in Worry-related Sleep Disturbances
Time frame: 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.
3 secondary outcomes
Change in Worry
Time frame: Baseline, 2 months
Change in Total Sleep Time (TST)
Time frame: Baseline, 2 months
Changes in Non-reactivity
Time frame: Baseline, 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35420589Gao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judson Brewer, MD, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-Delivered Mindfulness Training (MT) in people with Anxiety and Sleep Disturbance, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Worry-related Sleep Disturbances (time frame: Baseline, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022; AzTrials last refreshed its copy on 28 Oct 2026.