Clinical trial NCT04045275: Feasibility of a Mobile App on Sleep
Official title: Feasibility and Preliminary Effects of a Mobile App on Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Calm.com, Inc.
First posted: 2019-08-05
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design was a randomized control trial with baseline and post-intervention assessments (8 wks from baseline). Individuals reporting sleep difficulties were randomized to either a meditation mobile app intervention (Calm) group or a delayed response group. Participants were randomized after the completion of baseline and informed consent.
Primary purpose: TREATMENT

Brief summary: This study investigates the feasibility and effects of a mindfulness meditation mobile application on sleep for individuals reporting sleep disturbances.

Detailed description: The purpose of this study is to investigate the effects of a mindfulness meditation mobile application on sleep in individuals reporting sleep disturbances.

The investigator's guiding hypothesis is that the combined elements of a consumer-based mobile meditation app, Calm (e.g., daily mindfulness meditation, sleep stories and behavioral components), will be feasible, accepted and associated with sustained improvement in sleep among individuals who self-identify as having sleep disturbances. Calm provides daily, 10-minute, guided meditations grounded in mindfulness-based stress reduction (MBSR) and Vipassana meditation. Uniquely, Calm also offers "Sleep Stories", developed using techniques from Cognitive Behavioral Therapy and Relaxation Technique.

This is a randomized control feasibility study with an intervention and waitlist control.

Aim 1: Examine the feasibility of using a consumer-based mindful meditation app for \>10 mins/day over eight weeks for 100 adults who self-identify as sleep disturbed.

Aim 2: Explore the preliminary effects of Calm on sleep disturbance and emotional symptoms associated with sleep disturbance (i.e. stress, anxiety, depressive symptoms) as compared to those in a wait-list control group.

Recruitment: Participants will be recruited nationally via Internet-based strategies including social media (e.g. Facebook, Twitter, Instagram), social networking sites and email listservs. Recruitment flyers will be posted on social media websites. ResearchMatch.org will be also be utilized as a recruitment tool for this protocol.

Eligibility: Inclusion criteria are: (1) self-identify as sleep disturbed (i.e., score \>10 on the Insomnia Severity Index), (2) \>18 years of age, (3) English speaking, (4) willing to download the Calm app to their smartphone, and (5) have not practiced meditation more than 60 minutes a month in the past six months (6) willing to be randomized. Participants will report use of medication for sleep at baseline, mid-intervention and post-intervention and not excluded for medication.

Enrollment: Interested participants will complete a brief (5-10 minute) eligibility screener via Qualtrics. Participants will not be made know of sponsor name before randomization assignment to avoid disclosing the app that they will be using. Eligible participants will be asked to sign an electronic informed consent prior to the start of the intervention. After informed consents have been completed, participants (N=100) will be identified. Once eligible participants have been identified, they will be emailed instructions. Ineligible participants will be notified by email.

Tracking: Intervention participants (n=50) usage will be continuously tracked throughout the intervention by Calm.

Post-intervention: Post-intervention questionnaire will be emailed to intervention and control participants via a link from Qualtrics. All participants will have access to Calm after the 8-week study period, but will not be asked to meditate.

Eligibility criteria: Inclusion Criteria:

* self-identify as sleep disturbed (i.e., score \>10 on the Insomnia Severity Index)
* at least 18 years of age
* English speaking
* willing to download Clam app on their smartphone
* willing to be randomized

Exclusion Criteria:

* have participated in more than 60 minutes of meditation/month within the past six months

Primary outcomes:
measure: Acceptability, as measured by participants' satisfaction with the content in the mindful meditation app
timeFrame: Participant satisfaction is measured immediately after the the conclusion of the 8-week intervention.
measure: Acceptability, as measured by participants' perceptions of the appropriateness of the content in the mindful meditation app
timeFrame: Participants' perceptions of appropriateness are measured immediately after the the conclusion of the 8-week intervention.
measure: Demand, as assessed by the percentage of participants who use the mindful meditation app for the 70% of the prescribed weekly minutes (≥ 70 minutes/week)
timeFrame: Duration use app use is recorded continuously throughout the 8-week intervention.
measure: Demand, as assessed by the the comparative frequency of participants use of meditation, sleep meditation, and Sleep Stories
timeFrame: Frequency of use app use is recorded continuously throughout the 8-week intervention.
measure: Demand, as assessed by the the comparative duration of participants use of meditation, sleep meditation, and Sleep Stories
timeFrame: Duration use app use is recorded continuously throughout the 8-week intervention.
measure: Preliminary effects of the mindfulness meditation app on sleep disturbance, as assessed by changes in participants' nightly sleep duration over the course of the 8-week intervention period
timeFrame: Sleep diaries are completed daily throughout the 8-week intervention. Each morning, participants report on the previous night's sleep. Participants submit their daily diary entries at the end of each week.
measure: Preliminary effects of the mindfulness meditation app on sleep disturbance, as assessed by changes in the amount of time required for participants' to fall asleep over the course of the 8-week intervention period
timeFrame: Sleep diaries are completed daily throughout the 8-week intervention. Each morning, participants report on the previous night's sleep. Participants submit their daily diary entries at the end of each week.
measure: Preliminary effects of the mindfulness meditation app on sleep disturbance, as assessed by changes in the frequency of participants' nightly mid-sleep awakenings over the course of the 8-week intervention period
timeFrame: Sleep diaries are completed daily throughout the 8-week intervention. Each morning, participants report on the previous night's sleep. Participants submit their daily diary entries at the end of each week.
measure: Preliminary effects of the mindfulness meditation app on sleep disturbance, as assessed by changes in the amount of time spent awake after mid-sleep awakenings over the course of the 8-week intervention period
timeFrame: Sleep diaries are completed daily throughout the 8-week intervention. Each morning, participants report on the previous night's sleep. Participants submit their daily diary entries at the end of each week.
measure: Preliminary effects of the mindfulness meditation app on sleep disturbance, as assessed by changes in participants rating of sleep quality over the course of the 8-week intervention period
timeFrame: Sleep diaries are completed daily throughout the 8-week intervention. Each morning, participants report on the previous night's sleep. Participants submit their daily diary entries at the end of each week.
measure: Preliminary effects of the mindfulness meditation app on sleep disturbance, as assessed by changes in participants' pre- and post-intervention scores on the Cognitive and Somatic Arousal subscales of the Pre-Sleep Arousal Scale
timeFrame: The Pre-Sleep Arousal Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention
measure: Preliminary effects of the mindfulness meditation app on sleep fatigue, as assessed by changes in participants' pre- and post-intervention scores on the Fatigue Severity Scale
timeFrame: The Fatigue Severity Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention
measure: Preliminary effects of the mindfulness meditation app on sleepiness, as assessed by changes in participants' pre- and post-intervention scores on the Epworth Sleepiness Scale
timeFrame: The Epworth Sleepiness Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention
Secondary outcomes:
measure: Preliminary effects of the mindfulness meditation app on depression, as assessed by changes in participants' pre- and post-intervention scores on the Depression Anxiety Stress Scale-21 Items
timeFrame: The Depression Anxiety Stress Scale-21 Items will be completed at immediately before (i.e., baseline) and immediately after the intervention
measure: Preliminary effects of the mindfulness meditation app on depression, as assessed by changes in participants' pre- and post-intervention scores on the Hospital Anxiety and Depression Scale
timeFrame: The Hospital Anxiety and Depression Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention
measure: Preliminary effects of the mindfulness meditation app on anxiety, as assessed by changes in participants' pre- and post-intervention scores on the Depression Anxiety Stress Scale-21 Items
timeFrame: The Depression Anxiety Stress Scale-21 Items will be completed at immediately before (i.e., baseline) and immediately after the intervention
measure: Preliminary effects of the mindfulness meditation app on anxiety, as assessed by changes in participants' pre- and post-intervention scores on the Hospital Anxiety and Depression Scale
timeFrame: The Hospital Anxiety and Depression Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention
measure: Preliminary effects of the mindfulness meditation app on stress, as assessed by changes in participants' pre- and post-intervention scores on the Depression Anxiety Stress Scale-21 Items
timeFrame: The Depression Anxiety Stress Scale-21 Items will be completed at immediately before (i.e., baseline) and immediately after the intervention
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Jennifer Huberty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huberty JL, Green J, Puzia ME, Larkey L, Laird B, Vranceanu AM, Vlisides-Henry R, Irwin MR. Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244717. doi: 10.1371/journal.pone.0244717. eCollection 2021.