NCT05217602

Brief Summary

Over 75% of U.S. adults report significant stress, resulting in major health and economic costs. Mobile meditation apps are a feasible, effective, and scalable strategy for self-managing stress that is rapidly growing in popularity and thus represent a key tool for improving public health. However, existing intervention strategies for establishing persistent mobile health app adherence have largely been unsuccessful. Thus, there is a need for alternative strategies to move those who initiate meditation, i.e. new paying subscribers to a mobile meditation app. The investigators propose to synthesize theory- and evidence-based intervention approaches from psychology and behavioral economics to test novel combined strategies for establishing persistent adherence to meditation using the scalable Calm app. The purpose of this study is to evaluate the use of anchoring strategies in combination with pragmatic in-kind rewards to identify the most optimal strategy for establishing persistent meditation habits with a mobile app. The investigators aim to assess the adherence persistence to a 10 minutes per day Calm prescription in new, paying self-initiated Calm subscribers; investigate the mediating effect of anchoring plan adherence on adherence persistence to the Calm prescription; and estimate the dynamic relationship between meditation adherence and stress. The investigators hypothesize that participants using anchoring strategies in combination with pragmatic in-kind rewards will be more likely to adhere to the Calm prescription than the control condition with greater adherence observed among those participating in the anchoring plus time-contingent reward intervention; greater adherence to anchoring plans will lead to higher adherence persistence; and greater reductions in stress will be associated with more persistent meditation adherence across study groups. Investigators aim to recruit N=555 new, paying self-initiated Calm subscribers. Participants will be randomized into one of three groups with 185 participants in each group: anchoring plus in-kind rewards conditional on anchoring plan adherence; anchoring plus in-kind rewards conditional on meditating at any time of day; and usual Calm control condition without in-kind rewards.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

January 20, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

MeditationAnchoringMobile ApplicationStressAdherence PersistenceRewards

Outcome Measures

Primary Outcomes (2)

  • Mean Adherence Persistence Over Weeks 1-8

    Mean Adherence Persistence over weeks 1-8 will be measured using Calm app usage data from weeks 1-8 of the study, retrieved from the Calm informatics team (with the participant permission). Mean adherence is measured as the percent of days per week with any meditation.

    Change from baseline to post-intervention (week 8)

  • Mean Adherence Persistence Over Weeks 8-16

    Mean Adherence Persistence over weeks 8-16 will be measured using Calm app usage data from weeks 8-16 of the study, retrieved from the Calm informatics team (with the participant permission). Mean adherence is measured as the percent of days per week with any meditation.

    Change from post-intervention (week 8) to follow-up (week 16)

Secondary Outcomes (6)

  • Stress

    Change from baseline to post-intervention (week 8) to follow-up (week 16)

  • Anxiety

    Change from baseline to post-intervention (week 8) to follow-up (week 16)

  • Mindfulness

    Change from baseline to post-intervention (week 8) to follow-up (week 16)

  • PTSD

    Change from baseline to post-intervention (week 8) to follow-up (week 16)

  • Sleep Disturbances

    Change from baseline to post-intervention (week 8) to follow-up (week 16)

  • +1 more secondary outcomes

Study Arms (3)

AC+ARwdC

EXPERIMENTAL

Prescribed Calm usage = 10 minutes a day; Personalized anchoring plan for initiating any available meditation; Weekly text message reminders during the intervention period to reinforce the use of their anchoring plan; In-kind rewards only if they meditate using their anchoring plan on at least 8 days out of every 2 weeks (i.e., 14 days) during the 8 week intervention period (i.e., eligible for 4 prizes); $20 incentive for completing the baseline, week 8, and week 16 surveys

Behavioral: AC+ARwdC

AC+RwdC

EXPERIMENTAL

Prescribed Calm usage = 10 minutes a day; Personalized anchoring plan for initiating any available meditation; Weekly text message reminders during the intervention period to reinforce the use of their anchoring plan; In-kind rewards if they meditate on at least 8 days out of every 2 weeks (i.e., 14 days) during the 8 week intervention period (i.e., eligible for 4 prizes); $20 incentive for completing the baseline, week 8, and week 16 surveys

Behavioral: AC+RwdC

Usual Calm Control (UC)

ACTIVE COMPARATOR

Prescribed Calm usage = 10 minutes a day; Personalized anchoring plan for initiating any available meditation; $20 incentive for completing the baseline, week 8, and week 16 surveys

Behavioral: Usual Calm Control (UC)

Interventions

AC+ARwdCBEHAVIORAL

The Calm app is downloadable by participants onto their smartphone to access meditations and other Calm app features during the intervention period. Participants in the AC+ARwdC group will watch a video with information about the study, conditional rewards, and how to create an anchoring plan for their meditation habit. Weekly text message reminders will be sent during the intervention period to reinforce use of the anchoring plan. Participants in the AC+ARwdC group will be offered incentives for using their anchoring plan during the intervention period and for completing the baseline, post-intervention, and follow-up surveys.

AC+ARwdC
AC+RwdCBEHAVIORAL

The Calm app is downloadable by participants onto their smartphone to access meditations and other Calm app features during the intervention period. Participants in the AC+RwdC group will watch a video with information about the study, conditional rewards, and how to create an anchoring plan for their meditation habit. Weekly text message reminders will be sent during the intervention period to reinforce use of the anchoring plan. Participants in the AC+RwdC group will be offered incentives for meditating during the intervention period and for completing the baseline, post-intervention, and follow-up surveys.

AC+RwdC

The Calm app is downloadable by participants onto their smartphone to access meditations and other Calm app features during the intervention period. Participants in the UC group will watch a video with information about the study and how to create an anchoring plan for their meditation habit. Participants in the UC group will be offered incentives for completing the baseline, post-intervention, and follow-up surveys.

Usual Calm Control (UC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • New Calm subscribers (purchased at least 1 year membership)
  • Able to read/understand English
  • Have access to a smart phone on a daily basis
  • Reside in the US or a US territory
  • Willing to be randomized
  • Have a Perceived Stress Scale score greater than or equal to 15

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

Location

Related Publications (1)

  • Stecher C, Cloonan S, Linnemayr S, Huberty J. Combining Behavioral Economics-Based Incentives With the Anchoring Strategy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 28;12:e39930. doi: 10.2196/39930.

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Chad Stecher, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

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

January 20, 2022

First Posted

February 1, 2022

Study Start

February 22, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations