Calm Sleep Coaching

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).

Conditions

• Sleep Disturbance

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• Arizona State University

  lead OTHER

Principal Investigators

• Jennifer Huberty, PhD · Arizona State University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-21

Primary Completion

2020-12-22

Completion

2020-12-22

Countries

• United States

Study Locations