Calm Sleep Coaching
Testing the Feasibility and Preliminary Effects of a Six-week Online Program, "Calm Sleep Coaching", in Adults With Sleep Disturbance
1 other identifier
interventional
388
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedDecember 24, 2020
December 1, 2020
3 months
September 17, 2020
December 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep Disturbance
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 Outcomes (7)
Sleep Quality: Pittsburgh Sleep Diaries
Change from baseline to post-intervention (week 6)
Stress
Change from baseline to post-intervention (week 6)
Depression
Change from baseline to post-intervention (week 6)
Anxiety
Change from baseline to post-intervention (week 6)
Well-being
Change from baseline to post-intervention (week 6)
- +2 more secondary outcomes
Study Arms (4)
High-touch intervention
EXPERIMENTAL* 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
medium-touch intervention
EXPERIMENTAL* 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
low-touch intervention
EXPERIMENTAL* 1 Live video coaching session (week 1) * Chat messaging with 24-48 hour response time
Sleep education control
SHAM COMPARATOR* Weekly sleep education for six weeks * No interaction with coach
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Greater than or equal to 60 minutes/month of meditation for the past six months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona State University
Phoenix, Arizona, 85004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Huberty, PhD
Arizona State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 28, 2020
Study Start
September 21, 2020
Primary Completion
December 22, 2020
Study Completion
December 22, 2020
Last Updated
December 24, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share