Feasibility of a Mobile App on Sleep

NCT ID: NCT04045275

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2020-01-01

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.

Conditions

Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calm

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.

Group Type: EXPERIMENTAL

Calm

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Calm

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Calm.com, Inc.

INDUSTRY

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Huberty

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Huberty, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33411779 (View on PubMed)

Other Identifiers

STUDY00010050

Identifier Type: -

Identifier Source: org_study_id