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Completed

NCT Number: NCT04566822

Calm Sleep Coaching

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Touch intervention

Behavioral

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.

Medium Touch intervention

Behavioral

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.

Low Touch intervention

Behavioral

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.

Sleep Education Control

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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