Feasibility of a Mobile App on Sleep

NCT04045275 | Completed

• 1 other identifier: STUDY00010050
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (13)

• Acceptability, as measured by participants' satisfaction with the content in the mindful meditation app

  Participants' satisfaction will be measured by participant responses to the item, "On a scale of 1-5 (1=did not enjoy at all, 5=very much enjoyed), how would you rate your overall enjoyment with using Calm (i.e., likeable, pleasurable)?" on an investigator-developed survey. Participants rate their satisfaction on a five-point scale, ranging from 1 (did not enjoy at all) to 5 (very much enjoyed).

  Participant satisfaction is measured immediately after the the conclusion of the 8-week intervention.

• Acceptability, as measured by participants' perceptions of the appropriateness of the content in the mindful meditation app

  Participants' perceptions of appropriateness will be measured using six items on investigator-developed survey. Items inquire about participants' perceptions regarding the app's ease of use, aesthetics and graphics, and adequacy of the instruction (all rated on 1-5 scales, with higher ratings reflecting greater perceived appropriateness), and three items about the appropriateness of the duration of daily meditations, sleep meditations, and Sleep Stories (rated on a 1-4 scale, with higher ratings reflecting greater perceived appropriateness). Average scores will be reported for each item.

  Participants' perceptions of appropriateness are measured immediately after the the conclusion of the 8-week intervention.

• 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)

  The amount of time that participants use the app will be recorded by Calm (internally) and shared with Arizona State University.

  Duration use app use is recorded continuously throughout the 8-week intervention.

• Demand, as assessed by the the comparative frequency of participants use of meditation, sleep meditation, and Sleep Stories

  The frequency of using individual app components will be recorded by Calm (internally) and shared with Arizona State University.

  Frequency of use app use is recorded continuously throughout the 8-week intervention.

• Demand, as assessed by the the comparative duration of participants use of meditation, sleep meditation, and Sleep Stories

  The amount of time that participants use the app individual app components will be recorded by Calm (internally) and shared with Arizona State University.

  Duration use app use is recorded continuously throughout the 8-week intervention.

• 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

  Sleep duration will be calculated using participants' reports of the time they fell asleep at night, the time that they woke up in the morning, and the amount time spent awake after waking up during the night. These times are self-reported in a gold-standard daily sleep diary.

  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.

• 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

  The amount of time required to fall asleep will be measured by participants' self-reports in their daily sleep diaries.

  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.

• 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

  The frequency of mid-sleep awakenings will be measured by participants' self-reports in their daily sleep diaries.

  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.

• 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

  The amount of time spent awake after mid-sleep awakenings will be measured by participants' self-reports in their daily sleep diaries.

  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.

• 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

  Sleep quality will be measured by participants' responses to the question, "How would you rate the quality of your sleep? (1= very poor and 5= very good)," which is included in participants' daily sleep diaries.

  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.

• 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

  The Pre-Sleep Arousal Scale is a 16-item self-report questionnaire that measures arousal before sleep. Items describe symptoms of cognitive and somatic arousal. Using a five-point scale (1, not at all; 2, slightly: 3, moderately; 4, a lot; 5, extremely), participants rate extent to which they generally experience each symptom as they attempt to fall asleep. The Pre-Sleep Arousal Scale is comprised of two eight-item subscales, which assess Cognitive Somatic arousal. Subscale scores are determined by summing ratings from the included items. Possible scores on each subscale range from 8 to 40, with higher scores indicating greater pre-sleep arousal.

  The Pre-Sleep Arousal Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention

• 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

  The Fatigue Severity Scale is a nine-item self-report measure of fatigue and the extent to which fatigue interferes with daily living. Respondents rate the extent to which they agree with statements about their experience with fatigue during the past week. Items are scored on a seven-point scale ranging from 1 to 7 (1=strongly disagree, 7=strongly agree). Total scores range from 1 to 7, reflecting the mean rating of the items. Higher scores indicate greater fatigue.

  The Fatigue Severity Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention

• 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

  The Epworth Sleepiness Scale is an eight-item measure of daytime sleepiness. Respondents use a four-point scale to rate the likeliness that they would doze off or fall asleep in eight situations involving activities with low levels of stimulation, relative immobility, and relaxation, based on their usual way of life in recent times. Item ratings range from 0 to 3 (0=would never doze, 3=high chance of dozing). Items are summed to calculate a total score, ranging from 0 to 24, with higher scores indicating greater sleepiness.

  The Epworth Sleepiness Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention

Secondary Outcomes (5)

• 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

  The Depression Anxiety Stress Scale-21 Items will be completed at immediately before (i.e., baseline) and immediately after the intervention

• 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

  The Hospital Anxiety and Depression Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention

• 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

  The Depression Anxiety Stress Scale-21 Items will be completed at immediately before (i.e., baseline) and immediately after the intervention

• 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

  The Hospital Anxiety and Depression Scale will be completed at immediately before (i.e., baseline) and immediately after the intervention

• 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

  The Depression Anxiety Stress Scale-21 Items will be completed at immediately before (i.e., baseline) and immediately after the intervention

Study Arms (2)

Calm

EXPERIMENTAL

The intervention will occur across 8 weeks. During Week 1, it is suggested to intervention participants that they complete "7 days of Calm" meditation series (7 meditations, each approximately 10 minutes long, created to help users learn the basics of mindfulness meditations. For the remaining weeks (Week 2- Week 8) intervention participants will be asked to meditate for 10 minutes per day using any of the meditation sessions/features. Throughout the intervention, participants not completing 30 minutes of meditation per week will be sent reminders texts/emails.

Behavioral: Calm

Control

NO INTERVENTION

This group is a wait-list control group who will receive the intervention following the 8-week waiting period. Participants in this condition are instructed not to start meditating before the waiting period. After the 8-week waiting period, waitlist participants will receive the same intervention as described in the Calm Arm.

Interventions

Calm BEHAVIORAL

Calm provides daily, 10-minute, guided meditations grounded in mindfulness-based stress reduction (MBSR) and Vipassana meditation. Calm also offers "Sleep Stories," developed using techniques from Cognitive Behavioral Therapy and Relaxation Technique. Clam also includes behavioral components to reinforce sustained practice.

Calm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Arizona State University: lead
• Calm.com, Inc.: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• 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.

  PMID: 33411779 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Calmodulin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Intracellular Calcium-Sensing Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Calcium-Binding Proteins; Carrier Proteins; Proteins

Study Officials

• Jennifer Huberty, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: August 5, 2019
• Study Start: June 10, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)