Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy

NCT05285956 | Terminated

• 1 other identifier: Calm2021-102
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Test the effects of using Calm for its impact on stress, anxiety, and sleep in pregnant women using the following aims: Aim #1: Determine the feasibility of using Calm. Aim #2: Determine the preliminary efficacy of using Calm on stress, anxiety, and sleep. Exploratory Aim #3: Explore the preliminary efficacy of using Calm on self-reported birth outcomes

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (4)

• Change in Stress (Perceived Stress Scale)

  The Perceived Stress Scale (PSS) is a 10-item scale. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.

  Baseline, 4 weeks, 8 weeks

• Change in Sleep Quality (Pittsburgh Sleep Quality Index)

  The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions. The items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to form one "global" score, with a range of 0-21, "0" indicating no difficulty, and "21" indicating severe difficulties in all areas.

  Baseline, 4 weeks, 8 weeks

• Change in Depressive Symptoms (Edinburgh Postnatal Depression Scale)

  The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable, efficient, and proven effective screening tool for identifying patients at risk for "perinatal" depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. The scale indicates how the mother has felt during the previous week.

  Baseline, 4 weeks, 8 weeks

• Change in Anxiety (Pregnancy Related Anxiety Questionnaire)

  The Pregnancy Related Anxiety Questionnaire, Revised version 2 (PRAQ-R2 ) contains 10 questions, grouped into three subscales: fear of giving birth (FoGB; items 1, 2, and 6), worries of bearing a physically or mentally handicapped child (WaHC; items 4, 9, 10, and 11); and concern about own appearance (CoA; items 3, 5, and 7). An additional item is ("I am anxious about the delivery"). The total score (ranging from 10 to 50 points) and the sum of item scores that make up the three subscales are calculated. Higher scores are assumed to indicate increased pregnancy related anxiety intensity. No clinical cutoff point is currently defined for this tool.

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (3)

• Self-Reported Baby's Gestational Age at Birth

  2 weeks post due date

• Self-Reported Baby's Birth Weight

  2 weeks post due date

• Self-reported Childbirth Experience

  2 weeks post due date

Study Arms (2)

Intervention

EXPERIMENTAL

Participants (n=90) will be provided free access to and asked to register for the consumer-based mobile meditation app, Calm, on their phone. Participants will then receive an email containing one year of free access to Calm. Participants will be asked to use Calm at least 10 minutes per day for 8 weeks. Women will be asked to use 10 sessions of specific pregnancy content for the first four weeks and then will have autonomy to use the app how they prefer for the remainder of the study period (with continued encouragement to use the pregnancy meditations)

Behavioral: Calm app

Control

NO INTERVENTION

Participants (n=90) will be asked to continue with usual care and complete survey measures at each time point.

Interventions

Calm app BEHAVIORAL

Calm is a popular, subscription-based, meditation app accessible across web-based and smartphone platforms (iOS and Android) with over 100 million downloads and four million subscribers. The app offers a range of content rooted in mindfulness principles to help users incorporate mindfulness into their lives and generally promote wellbeing (e.g., a large library of guided meditations including the 10-minute Daily Calm, Sleep Stories, educational courses, mindful movement, music, and nature scenes and sounds). Calm also teaches users the basics of mindfulness, includes components to remind users to meditate, track user activity, and allow users to share their status with others. The feasibility of the app and its efficacy for improving mental health outcomes (i.e., stress, anxiety, and depressive symptoms), mindfulness, and sleep have been previously tested in various populations providing evidence that using Calm may improve wellbeing.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women 14-16 or 28-30 weeks gestation
• Resident of United States
• Access to regular WiFI
• Access to a smartphone regularly
• Willing to download an app onto their smartphone
• Score of \>13 on Perceived Stress Scale (PSS-10)\] 31 and sleep quality \[score of \>5 on Pittsburgh Sleep Quality Index (PSQI)\]
• Have not practiced meditation more than 60 minutes a month in the past six months
• Willing to be randomized to one of two groups.

You may not qualify if:

• \<18 years of age
• Unable to consent
• First trimester (less than 14 weeks)

Sponsors & Collaborators

• Calm.com, Inc.: lead

Study Sites (1)

Calm, Inc.

San Francisco, California, 94105, United States

Location

Related Publications (6)

• Huberty J, Puzia ME, Green J, Vlisides-Henry RD, Larkey L, Irwin MR, Vranceanu AM. A mindfulness meditation mobile app improves depression and anxiety in adults with sleep disturbance: Analysis from a randomized controlled trial. Gen Hosp Psychiatry. 2021 Nov-Dec;73:30-37. doi: 10.1016/j.genhosppsych.2021.09.004. Epub 2021 Sep 11.

  PMID: 34537477 BACKGROUND

• Huberty JL, Green J, Puzia ME, Larkey L, Laird B, Vranceanu AM, Vlisides-Henry R, Irwin MR. Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244717. doi: 10.1371/journal.pone.0244717. eCollection 2021.

  PMID: 33411779 BACKGROUND

• Huberty J, Puzia ME, Larkey L, Irwin MR, Vranceanu AM. Use of the Consumer-Based Meditation App Calm for Sleep Disturbances: Cross-Sectional Survey Study. JMIR Form Res. 2020 Nov 13;4(11):e19508. doi: 10.2196/19508.

  PMID: 33185552 BACKGROUND

• Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.

  PMID: 31237569 BACKGROUND

• Kwok OM, Underhill AT, Berry JW, Luo W, Elliott TR, Yoon M. Analyzing Longitudinal Data with Multilevel Models: An Example with Individuals Living with Lower Extremity Intra-articular Fractures. Rehabil Psychol. 2008 Aug;53(3):370-386. doi: 10.1037/a0012765.

  PMID: 19649151 BACKGROUND

• Gravel J, Opatrny L, Shapiro S. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? Clin Trials. 2007;4(4):350-6. doi: 10.1177/1740774507081223.

  PMID: 17848496 BACKGROUND

Study Officials

• Jen Huberty, PhD

  Calm.com, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Researchers will assign participants to groups based on a randomized allocation list, which will be generated prior to the start study by a team member who is not involved in the group-assignment process. Allocation sequences will be concealed until the time of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)