Calm Sleep Coaching

Sleep Disturbance Clinical Trial

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

Status Completed

Clinical Trial Summary

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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

• NCT number: NCT04566822
• Study type: Interventional
• Source: Arizona State University
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Completion date: December 22, 2020