Calm Sleep Coaching

• ClinicalTrials.gov Identifier: NCT04566822
• Recruitment Status: Completed
• First Posted: September 28, 2020
• Last Update Posted: December 24, 2020
• Sponsor: Arizona State University
• Information provided by (Responsible Party): Arizona State University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Sleep Disturbance	Behavioral: High Touch intervention; Behavioral: Medium Touch intervention; Behavioral: Low Touch intervention; Behavioral: Sleep Education Control	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 388 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The participants will be blinded as to which group is receiving the intervention being assessed
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Testing the Feasibility and Preliminary Effects of a Six-week Online Program, "Calm Sleep Coaching", in Adults With Sleep Disturbance
• Actual Study Start Date: September 21, 2020
• Actual Primary Completion Date: December 22, 2020
• Actual Study Completion Date: December 22, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: High-touch intervention; 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	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.
Experimental: medium-touch intervention; 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	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.
Experimental: low-touch intervention; 1 Live video coaching session (week 1); Chat messaging with 24-48 hour response time	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.
Sham Comparator: Sleep education control; Weekly sleep education for six weeks; No interaction with coach	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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Arizona State University

Phoenix, Arizona, United States, 85004

Sponsors and Collaborators

Arizona State University

Investigators

• Principal Investigator: Jennifer Huberty, PhD; Arizona State University

More Information

• Responsible Party: Arizona State University
• ClinicalTrials.gov Identifier: NCT04566822
• Other Study ID Numbers: STUDY00012385
• First Posted: September 28, 2020
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dyssomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders