Calm Sleep Coaching

December 22, 2020 updated by: Arizona State University

Testing the Feasibility and Preliminary Effects of a Six-week Online Program, "Calm Sleep Coaching", in Adults With Sleep Disturbance

The Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic, with more than 70 million US adults experiencing insomnia each year. However, access to current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for Insomnia [CBT-I]) is limited due to the need for specialized providers as well as monetary and logistical barriers that prevent many individuals from attending in-person treatment sessions (e.g., scheduling, transportation, childcare). Novel modes of delivery are needed to extend the benefits of these treatments to a wider range of individuals in need.

The purpose of this study is to evaluate Calm Sleep Coaching in adults with sleep disturbance (score of greater than or equal to 8 on the Insomnia Severity Index) by 1) determining the feasibility (i.e., acceptability, demand) of Calm Sleep Coaching and 2) determining the preliminary effects of Calm Sleep Coaching on primary (sleep quality) and secondary outcomes (i.e., symptoms of insomnia, mental health, well-being, resilience, and productivity). Investigators also aim to explore coaches' experiences with implementation of Calm Sleep Coaching using an investigator developed survey and assess the participants stage of change (transtheoretical model) throughout the program. Investigators hypothesize that 1) Calm Sleep Coaching will be feasible among individuals with sleep disturbance and 2) participating in the Calm Sleep Coaching program is associated with improvements in primary and secondary outcomes compared to the control group (with greater improvements observed among those participating in higher touch coaching interventions).

Investigators aim to recruit N=200 participants. Participants will be randomized into one of four groups: 1) High-touch intervention (N=50; real-time video and chat messaging, coach response via live videos), 2) medium-touch intervention (N=50; real-time video and pre-recorded video and chat messaging with response from coach), 3) low-touch intervention (N=50; chat messaging with response from coach), or 4) Sleep education control (N=50; no coaching).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic, with more than 70 million US adults experiencing insomnia each year. However, access to current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for Insomnia [CBT-I]) is limited due to the need for specialized providers as well as monetary and logistical barriers that prevent many individuals from attending in-person treatment sessions (e.g., scheduling, transportation, childcare). Novel modes of delivery are needed to extend the benefits of these treatments to a wider range of individuals in need.

For many individuals, digital intervention platforms may serve as an attractive alternative to receiving treatment and health services that are otherwise difficult to access. The Calm app is a consumer-based meditation smartphone app that is easy to use, inexpensive, and widely accessible (currently over 3.1 million paying subscribers). Recent surveys (N=12,151; N=11,210) indicate that between 76 and 89% of the Calm app subscribers were experiencing sleep difficulties when they downloaded the app, and 63-76% downloaded the Calm app specifically to improve their sleep. Given the Calm apps popularity and the need for techniques to improve sleep, leveraging the Calm apps existing platform will allow for efficient dissemination of a digital sleep intervention (i.e., Calm Sleep Coaching).

The Calm app has developed a new 6-week online sleep-coaching school (Calm Sleep Coaching) to improve the quality and quantity of sleep for individuals who complete the program. The development of Calm Sleep Coaching was informed by evidence-based techniques (e.g., CBTi, mindfulness practices, Self-Determination Theory, and Social Cognitive Theory). However, the feasibility and effectiveness of Calm Sleep Coaching has not yet been evaluated.

Therefore, the purpose of this study is to evaluate Calm Sleep Coaching in adults with sleep disturbance (score of greater than or equal to 8 on the Insomnia Severity Index) by 1) determining the feasibility (i.e., acceptability, demand) of Calm Sleep Coaching and 2) determining the preliminary effects of Calm Sleep Coaching on primary (sleep quality) and secondary outcomes (i.e., symptoms of insomnia, mental health, well-being, resilience, and productivity). Investigators also aim to explore coaches' experiences with implementation of Calm Sleep Coaching using an investigator developed survey and assess the participants stage of change (transtheoretical model) throughout the program. Investigators hypothesize that 1) Calm Sleep Coaching will be feasible among individuals with sleep disturbance and 2) participating in the Calm Sleep Coaching program is associated with improvements in primary and secondary outcomes compared to the control group (with greater improvements observed among those participating in higher touch coaching interventions).

Investigators aim to recruit N=200 participants. Participants will be randomized into one of four groups: 1) High-touch intervention (N=50; real-time video and chat messaging, coach response via live videos), 2) medium-touch intervention (N=50; real-time video and pre-recorded video and chat messaging with response from coach), 3) low-touch intervention (N=50; chat messaging with response from coach), or 4) Sleep education control (N=50; no coaching).

STUDY OBJECTIVES

Aim 1: Examine the feasibility (acceptability, demand) of the Calm Sleep Coaching six-week program in adults with sleep disturbance (N=200).

Acceptability is defined as participant satisfaction with content including perceived appropriateness and usefulness of Calm Sleep Coaching for improving sleep. Acceptability will be measured using an investigator developed satisfaction survey. H1.1: At least 70% of participants will report that overall, they were satisfied with Calm Sleep Coaching. H1.2: At least 70% of participants will perceive the components of Calm Sleep Coaching to be appropriate and useful for reducing or managing sleep disturbance.

Demand is defined as the number of sessions attended with the sleep coaches and compliance with sleep diaries. H1.3: At least 70% of participants will attend 4/6 of Calm Sleep Coaching sessions and (2) at least 70% will complete 70% of daily sleep diaries.

Aim 2: Test the preliminary effects of the Calm Sleep Coaching program on primary (sleep quality) and secondary outcomes (i.e., symptoms of insomnia, mental health, well-being, resilience, and productivity). Investigators will test associations between participation in Calm Sleep Coaching and changes in sleep disturbance (primary outcome) and symptoms related to sleep disturbance (secondary outcomes; i.e., stress, anxiety, depressive symptoms, well-being, resilience and productivity) compared to those in a sleep education control group. H2.1: Participating in 6 weeks of Calm Sleep Coaching will be associated with reductions in sleep disturbance. H2.2: Participating in 6 weeks of Calm Sleep Coaching will be associated with improvement in symptoms related to sleep disturbance.

Aim 3 (exploratory): Assess coaches experiences with implementation of Calm Sleep Coaching via investigator developed survey. Questions asked will assess general experiences, challenges, usability, content, and recommendations for change.

Aim 4 (exploratory): Assess the participants stage of change (transtheoretical model) throughout the program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Own a smartphone
  • Reside in the US or a US territory
  • Only English speakers
  • Score of greater than or equal to 8 on the Insomnia Severity Index
  • Willing to download the Calm app to their smartphone
  • Willing to be randomized

Exclusion Criteria:

• Greater than or equal to 60 minutes/month of meditation for the past six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-touch intervention
  • 6 live video coaching sessions
  • Coaching/feedback is tailored to the individual and adaptive to their progress
  • Member can send the Coach messages between sessions, but the Coach will not respond until the live session
Behavioral: High Touch intervention
The Calm app is downloadable by participants onto their smartphone to access the Calm app and Calm Sleep Coaching. The Calm app is used to deliver the intervention to experimental group participants.
Experimental: medium-touch intervention
  • 3 live video coaching sessions
  • 2 live videos are optional (recommended for end of Weeks 3 and 5, but member can take advantage of them anytime)
  • 2-4 pre-recorded video sessions at end of the week. Pre-recorded videos provided in the absence of live sessions
  • Chat messaging between sessions with 24-48 hour response time
Behavioral: Medium Touch intervention
The Calm app is downloadable by participants onto their smartphone to access the Calm app and Calm Sleep Coaching. The Calm app is used to deliver the intervention to experimental group participants.
Experimental: low-touch intervention
  • 1 Live video coaching session (week 1)
  • Chat messaging with 24-48 hour response time
Behavioral: Low Touch intervention
The Calm app is downloadable by participants onto their smartphone to access the Calm app and Calm Sleep Coaching. The Calm app is used to deliver the intervention to experimental group participants.
Sham Comparator: Sleep education control
  • Weekly sleep education for six weeks
  • No interaction with coach
Behavioral: Sleep Education Control
Participants in the sleep education control will not have access to a coach. Weekly sleep education will be accessible to the participant on a weekly basis. The sleep education content will be the same that is provided to the intervention participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Disturbance
Time Frame: Change from baseline to post-intervention (week 6)
Sleep Disturbance will be measured with the Insomnia Severity Index. Scores range from 0-28 with higher score indicates more severe insomnia.
Change from baseline to post-intervention (week 6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Quality: Pittsburgh Sleep Diaries
Time Frame: Change from baseline to post-intervention (week 6)
Sleep Quality will be measured using the Pittsburgh Sleep Diaries. Scores range from 0-8 with higher scores indicating greater sleep quality.
Change from baseline to post-intervention (week 6)
Stress
Time Frame: Change from baseline to post-intervention (week 6)
Stress will be measured using the Perceived Stress Scale. Scores on the PSS-10 range from 0-40 with greater scores indicating greater stress.
Change from baseline to post-intervention (week 6)
Depression
Time Frame: Change from baseline to post-intervention (week 6)
Depression will be measured using the Patient Health Questionnaire Depression Scale-8. Score on the PHQ-8 range from 0-24 with higher scores indicating greater depressive symptoms.
Change from baseline to post-intervention (week 6)
Anxiety
Time Frame: Change from baseline to post-intervention (week 6)
Anxiety will be measured using the General Anxiety Disorder-7. Scores on the GAD-7 range from 0-21 with higher scores indicating greater anxiety.
Change from baseline to post-intervention (week 6)
Well-being
Time Frame: Change from baseline to post-intervention (week 6)
Well-being will be measured using the World Health Organization-Five Well-Being Index. Scores on the WHO-5 range from 0-25 with higher scores indicating greater sense of well-being.
Change from baseline to post-intervention (week 6)
Resilience
Time Frame: Change from baseline to post-intervention (week 6)
Resilience will be measured using the Connor-Davis Brief Resilience Scale. Scores on the CD-RISC-10 range from 0-40 with higher scores indicating greater resilience.
Change from baseline to post-intervention (week 6)
Productivity
Time Frame: Change from baseline to post-intervention (week 6)
Productivity will be measured using the Work Productivity and Activity Impairment Questionnaire. Scores on the WPAI:GH are provided as a percentage with higher numbers indicating greater impairment and less productivity.
Change from baseline to post-intervention (week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00012385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disturbance

Clinical Trials on High Touch intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings