Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04566822 |
| Other study ID # |
STUDY00012385 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2020 |
| Est. completion date |
December 22, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Arizona State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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).
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.
