StressNCT05217602
Incentivizing Meditation App Habit Formation
A study testing AC+ARwdC and AC+RwdC in people with Stress and Adherence, Treatment, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Adherence, Treatment
- What is being tested?
- AC+ARwdC and AC+RwdC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Greater than or equal to 60 minutes/month of meditation for the past six months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Stress among U.S. adults is widespread with major health and economic costs. Over 75% of U.S. adults report significant stress. Stress costs the U.S. $300 billion a year because of absenteeism, accidents, reduced productivity, employee turnover, and direct medical, legal, and insurance costs. There is an urgent need for accessible, effective, and scalable strategies to manage stress. This study employs an evidence-based mental health mobile app that is scalable.
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. Given the ubiquity of smart phones, mobile health apps are an ideal platform for the remote delivery of health behavior regimens, such as meditation, as they can overcome several important barriers, such as cost and limited access, commonly reported by in-person programs. However, a majority of those who initiate use of a mobile meditation app do not persistently meditate and thus may not attain the corresponding mental health benefits. Recent research studies that have implemented app-based meditation have observed significant dropout and low adherence rates across different populations. Dropout rates have ranged from 54% to 77% among general samples of U.S. adults. Even when study participants do not officially drop out, adherence to app-based meditation interventions can be as low as 24%.
Existing intervention strategies for establishing persistent mobile health app adherence have largely been unsuccessful. Currently, little is known about how to get users to persistently adhere to a mobile health app. The significant rates of dropout and low adherence to mobile health apps indicate the presence of individual barriers to engagement. Proposed socio-cognitive intervention strategies have focused on bolstering self-efficacy for dealing with obstacles, increasing motivation, and reiterating the long-term benefits of performing a behavior, but to date, these strategies have largely been unsuccessful for establishing persistent health behaviors. Thus, there is a need for alternative strategies to move those who initiate meditation, i.e. new paying subscribers to a mobile meditation app, from preparation or action to maintenance. 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.
Anchoring is a theory-based strategy for establishing persistent habits, but many participants need additional support to adhere to this approach. Psychologists have shown that repeatedly performing a behavior in response to the same stimulus or cue establishes a habit that can persist long term, i.e. beyond six months, with little or no cognitive effort. Through such "context-dependent repetition," exposure to the stimulus reflexively, or non-consciously, triggers initiation of the behavior. In this way, behavioral control is delegated to the external stimulus, thereby reducing the demand on an individual's attention and memory processes. Such external stimuli have been found to support many persistent health habits, such as high medication adherence, physical activity, reduced sitting, healthy hand washing, dental hygiene, and dietary habits.
Traditional external rewards that are unconditional on the timing and context of behavior can successfully initiate healthy behaviors, but the behaviors rarely persist after rewards are withdrawn. Behavioral economic theory predicts that short-term rewards will increase one's motivation to perform the targeted behavior and that short-term increases in behavioral performance increase one's utility or perceived benefit from continuing the behavior, thus forming a habit. The use of in-kind rewards, such as app-branded prizes like Calm merchandise, are often found to be more effective for increasing motivation than financial rewards. However, findings from the behavioral economics literature that used rewards, often financial incentives, show success only for initiating behavioral improvements across a wide range of health behaviors, such as physical activity, weight loss, and medication adherence, but a lack of success in maintaining the health behavior after rewards are withdrawn. Importantly, these studies all offered rewards for the targeted health behavior, unconditional on the timing and context of performing the behavior. Among the studies that evaluated the persistence of the health behavior after rewards were withdrawn, it is almost always found that the behavior returned to baseline levels of performance.
Time-contingent rewards may hold the key for leveraging the short-term effectiveness of rewards with the long-term efficacy of habits. One proposed explanation for the lack of long-term effectiveness of traditional rewards that are unconditional on the timing and context of behavior is that rewards crowd out motivation. However, one systematic review of health behavior interventions found that rewards increased health behavior motivation. One study found increased motivation from rewards for medication adherence, and also identified a subset for whom high medication adherence persisted after rewards were withdrawn: participants who used consistent stimuli or cues for their daily pill-taking. This observation, combined with the psychological theory of habits, informs the novel use of rewards conditional on anchoring plan performance for establishing persistent meditation adherence. One way to operationalize rewards for anchoring plan performance is to use "time-contingent" rewards that are conditional on performing the targeted behavior at approximately the same time that the planned anchor, i.e. existing routine, is expected to occur each day.
Therefore, the proposed intervention will test anchoring in combination with pragmatic in-kind rewards in two conditions: a) conditional on meditating at any time of day, and b) conditional on anchoring plan adherence, both compared to using Calm without additional strategies, to identify the most optimal strategy for establishing persistent meditation habits with a mobile app.
STUDY OBJECTIVES Aim 1: Assess adherence persistence to the 10 minutes per day Calm prescription in 555 new, paying self-initiated Calm subscribers for 16 weeks. H1.1: Over the 8-week follow-up period, participants in the intervention groups will be more likely to adhere to the 10 min/day Calm prescription than usual Calm condition. H1.2: Further, participants receiving pragmatic in-kind rewards tied to anchoring plan performance will have more persistent adherence than those receiving pragmatic in-kind rewards tied to meditation at any time of day.
Aim 2: Investigate the mediating effect of anchoring plan adherence during the 8-week intervention on adherence persistence to the Calm prescription. H2.1: Greater adherence to participants' anchoring plans during the intervention will lead to higher adherence persistence over the 8-week follow-up.
Aim 3: To estimate the dynamic relationship between meditation adherence and stress. H3.1: Greater reductions in stress will be associated with more persistent meditation adherence across study groups.
- Conditions
- Stress, Adherence, Treatment
- Being tested
- AC+ARwdC, AC+RwdC, Usual Calm Control (UC)
- Keywords
- Meditation, Anchoring, Mobile Application, Stress, Adherence Persistence, Rewards
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC+ARwdCBehavioural
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+RwdCBehavioural
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.
Usual Calm Control (UC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: Usual Calm Control (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from post-intervention (week 8) to follow-up (week 16)
Secondary outcomes (6)
Stress
Stress will be measured using the Perceived Stress Scale. Scores on the PSS-10 range from 0-40 with greater scores indicating greater stress.
Measured: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Anxiety
Anxiety will be measured using the Hospital Anxiety and Depression Scale (Anxiety Subscale). Scores on the HADS Anxiety Subscale range from 0-21 with higher scores indicating greater anxiety.
Measured: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Mindfulness
Mindfulness will be measured using the Mindful Attention Awareness Scale. Scores on the MAAS range from 1-6 with higher scores indicating greater dispositional mindfulness.
Measured: Change from baseline to post-intervention (week 8) to follow-up (week 16)
PTSD
PTSD will be measured using the Impact of Events Scale-Revised. Scores on the IES-R range from 0-88 with higher scores indicating greater severity of PTSD symptoms.
Measured: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Sleep Disturbances
Sleep Disturbances will be measured with the Insomnia Severity Index. Scores on the ISI range from 0-28 with higher score indicates more severe insomnia.
Measured: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Habit Strength
Habit Strength will be measured with the Self-Report Habit Index. Higher scores on the SRHI indicate greater habit strength.
Measured: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start22 Feb 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Calm.com, Inc.
- Responsible party
- Sponsor
- Investigators
- Chad Stecher, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217602
- Sponsor's protocol ID
- STUDY00014710
- Status last verified
- Nov 2022
- First submitted
- 20 Jan 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37115610
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentivizing Meditation App Habit Formation
- ClinicalTrials.gov ID
- NCT05217602
- Acronym / sponsor ID
- STUDY00014710
- Conditions
- Stress, Adherence, Treatment
- Keywords
- Meditation, Anchoring, Mobile Application, Stress, Adherence Persistence, Rewards
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Calm.com, Inc.
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stress among U.S. adults is widespread with major health and economic costs. Over 75% of U.S. adults report significant stress. Stress costs the U.S. $300 billion a year because of absenteeism, accidents, reduced productivity, employee turnover, and direct medical, legal, and insurance costs. There is an urgent need for accessible, effective, and scalable strategies to manage stress. This study employs an evidence-based mental health mobile app that is scalable.
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. Given the ubiquity of smart phones, mobile health apps are an ideal platform for the remote delivery of health behavior regimens, such as meditation, as they can overcome several important barriers, such as cost and limited access, commonly reported by in-person programs. However, a majority of those who initiate use of a mobile meditation app do not persistently meditate and thus may not attain the corresponding mental health benefits. Recent research studies that have implemented app-based meditation have observed significant dropout and low adherence rates across different populations. Dropout rates have ranged from 54% to 77% among general samples of U.S. adults. Even when study participants do not officially drop out, adherence to app-based meditation interventions can be as low as 24%.
Existing intervention strategies for establishing persistent mobile health app adherence have largely been unsuccessful. Currently, little is known about how to get users to persistently adhere to a mobile health app. The significant rates of dropout and low adherence to mobile health apps indicate the presence of individual barriers to engagement. Proposed socio-cognitive intervention strategies have focused on bolstering self-efficacy for dealing with obstacles, increasing motivation, and reiterating the long-term benefits of performing a behavior, but to date, these strategies have largely been unsuccessful for establishing persistent health behaviors. Thus, there is a need for alternative strategies to move those who initiate meditation, i.e. new paying subscribers to a mobile meditation app, from preparation or action to maintenance. 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.
Anchoring is a theory-based strategy for establishing persistent habits, but many participants need additional support to adhere to this approach. Psychologists have shown that repeatedly performing a behavior in response to the same stimulus or cue establishes a habit that can persist long term, i.e. beyond six months, with little or no cognitive effort. Through such "context-dependent repetition," exposure to the stimulus reflexively, or non-consciously, triggers initiation of the behavior. In this way, behavioral control is delegated to the external stimulus, thereby reducing the demand on an individual's attention and memory processes. Such external stimuli have been found to support many persistent health habits, such as high medication adherence, physical activity, reduced sitting, healthy hand washing, dental hygiene, and dietary habits.
Traditional external rewards that are unconditional on the timing and context of behavior can successfully initiate healthy behaviors, but the behaviors rarely persist after rewards are withdrawn. Behavioral economic theory predicts that short-term rewards will increase one's motivation to perform the targeted behavior and that short-term increases in behavioral performance increase one's utility or perceived benefit from continuing the behavior, thus forming a habit. The use of in-kind rewards, such as app-branded prizes like Calm merchandise, are often found to be more effective for increasing motivation than financial rewards. However, findings from the behavioral economics literature that used rewards, often financial incentives, show success only for initiating behavioral improvements across a wide range of health behaviors, such as physical activity, weight loss, and medication adherence, but a lack of success in maintaining the health behavior after rewards are withdrawn. Importantly, these studies all offered rewards for the targeted health behavior, unconditional on the timing and context of performing the behavior. Among the studies that evaluated the persistence of the health behavior after rewards were withdrawn, it is almost always found that the behavior returned to baseline levels of performance.
Time-contingent rewards may hold the key for leveraging the short-term effectiveness of rewards with the long-term efficacy of habits. One proposed explanation for the lack of long-term effectiveness of traditional rewards that are unconditional on the timing and context of behavior is that rewards crowd out motivation. However, one systematic review of health behavior interventions found that rewards increased health behavior motivation. One study found increased motivation from rewards for medication adherence, and also identified a subset for whom high medication adherence persisted after rewards were withdrawn: participants who used consistent stimuli or cues for their daily pill-taking. This observation, combined with the psychological theory of habits, informs the novel use of rewards conditional on anchoring plan performance for establishing persistent meditation adherence. One way to operationalize rewards for anchoring plan performance is to use "time-contingent" rewards that are conditional on performing the targeted behavior at approximately the same time that the planned anchor, i.e. existing routine, is expected to occur each day.
Therefore, the proposed intervention will test anchoring in combination with pragmatic in-kind rewards in two conditions: a) conditional on meditating at any time of day, and b) conditional on anchoring plan adherence, both compared to using Calm without additional strategies, to identify the most optimal strategy for establishing persistent meditation habits with a mobile app.
STUDY OBJECTIVES Aim 1: Assess adherence persistence to the 10 minutes per day Calm prescription in 555 new, paying self-initiated Calm subscribers for 16 weeks. H1.1: Over the 8-week follow-up period, participants in the intervention groups will be more likely to adhere to the 10 min/day Calm prescription than usual Calm condition. H1.2: Further, participants receiving pragmatic in-kind rewards tied to anchoring plan performance will have more persistent adherence than those receiving pragmatic in-kind rewards tied to meditation at any time of day.
Aim 2: Investigate the mediating effect of anchoring plan adherence during the 8-week intervention on adherence persistence to the Calm prescription. H2.1: Greater adherence to participants' anchoring plans during the intervention will lead to higher adherence persistence over the 8-week follow-up.
Aim 3: To estimate the dynamic relationship between meditation adherence and stress. H3.1: Greater reductions in stress will be associated with more persistent meditation adherence across study groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AC+ARwdC | Experimental | Behavioral: AC+ARwdCPrescribed 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 |
| AC+RwdC | Experimental | Behavioral: AC+RwdCPrescribed 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 |
| Usual Calm Control (UC) | Active comparator | Behavioral: Usual Calm Control (UC)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Greater than or equal to 60 minutes/month of meditation for the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC+ARwdCThe 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. | Behavioural | AC+ARwdC |
| AC+RwdCThe 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. | Behavioural | AC+RwdC |
| Usual Calm Control (UC)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. | Behavioural | Usual Calm Control (UC) |
Primary outcome
Mean Adherence Persistence Over Weeks 1-8
Time frame: Change from baseline to post-intervention (week 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.
Mean Adherence Persistence Over Weeks 8-16
Time frame: Change from post-intervention (week 8) to follow-up (week 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.
6 secondary outcomes
Stress
Time frame: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Anxiety
Time frame: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Mindfulness
Time frame: Change from baseline to post-intervention (week 8) to follow-up (week 16)
PTSD
Time frame: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Sleep Disturbances
Time frame: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Habit Strength
Time frame: Change from baseline to post-intervention (week 8) to follow-up (week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 37115610Stecher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Stecher, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AC+ARwdC and AC+RwdC in people with Stress and Adherence, Treatment, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Adherence Persistence Over Weeks 1-8 (time frame: Change from baseline to post-intervention (week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.