StressNCT04589520
The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge
A study testing HeartBot App in people with Stress and Mental Health Wellness 1, run by Ranjani Iyer at 1 site in United States.
Trial summary
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Mental Health Wellness 1
- What is being tested?
- HeartBot App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2019to 31 Oct 2019
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age.
Who cannot join
- Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.
Trial locations and contacts
1 site in 1 country.
About this study
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older.
Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older?
Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.
- Conditions
- Stress, Mental Health Wellness 1
- Being tested
- HeartBot App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartBot AppBehavioural
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness to deal with daily stress and anxiety in a healthy, productive manner.
| Study group | Role | What they receive |
|---|---|---|
| HeartBot Group | Experimental | The HeartBot group downloaded the app and used it daily for 21 days based on a calendar that provided them with step by step outlines of the tools for each day. Receives: Behavioral: HeartBot App |
| Control Group | No intervention | The control group did not download the app and experienced no change to their daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress Levels
Participant stress levels were measured using the Perceived Stress Scale (PSS). This 10-item scale measures the degree to which a situation in someone's life is considered stressful .
Measured: 21 days for 30 minutes every day based on a 21-day calendar
Secondary outcomes (1)
Change in Emotional Wellbeing
The emotional wellness of the participants was measured using the EPOCH measure of adolescent wellbeing. This is a 20-item scale used to measure five different positive characteristics: Engagement, Perseverance, Optimism, Connectedness, and Happiness.
Measured: 21 days for 30 minutes every day based on a 21-day calendar
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start18 Aug 2019
- Primary completion21 Oct 2019
- Study completion31 Oct 2019
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranjani Iyer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ranjani Iyer, Heartfulness Institute
- Investigators
- Ranjani B Iyer, PhD, Principal investigator, Heartfulness Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589520
- Sponsor's protocol ID
- 2019/07/11
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.
Publications
Iyer L, Iyer RB, Kumar V. A Relaxation App (HeartBot) for Stress and Emotional Well-Being Over a 21-Day Challenge: Randomized Survey Study. JMIR Form Res. 2021 Jan 29;5(1):e22041. doi: 10.2196/22041.
PubMed 33455902
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge
- ClinicalTrials.gov ID
- NCT04589520
- Acronym / sponsor ID
- 2019/07/11
- Conditions
- Stress, Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ranjani IyerUniversity, hospital or other
- Study start
- 18 Aug 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 19 Oct 2020 (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.
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older.
Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older?
Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartBot Group | Experimental | Behavioral: HeartBot AppThe HeartBot group downloaded the app and used it daily for 21 days based on a calendar that provided them with step by step outlines of the tools for each day. |
| Control Group | No intervention | –The control group did not download the app and experienced no change to their daily routines. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age.
Key exclusion criteria (1 listed)
- Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.
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 |
|---|---|---|
| HeartBot AppHeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness to deal with daily stress and anxiety in a healthy, productive manner. | Behavioural | HeartBot Group |
Primary outcome
Change in Stress Levels
Time frame: 21 days for 30 minutes every day based on a 21-day calendar
Participant stress levels were measured using the Perceived Stress Scale (PSS). This 10-item scale measures the degree to which a situation in someone's life is considered stressful .
1 secondary outcome
Change in Emotional Wellbeing
Time frame: 21 days for 30 minutes every day based on a 21-day calendar
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 19 Oct 2020.
- Derived from this study: PubMed 33455902Iyer L, Iyer RB, Kumar V. A Relaxation App (HeartBot) for Stress and Emotional Well-Being Over a 21-Day Challenge: Randomized Survey Study. JMIR Form Res. 2021 Jan 29;5(1):e22041. doi: 10.2196/22041.
- Individual participant dataSharing planned: Yes. Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.
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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.
Ranjani B Iyer, PhD principal investigator
Heartfulness Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartBot App in people with Stress and Mental Health Wellness 1, run by Ranjani Iyer 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 1 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 19 Oct 2020. 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?
Change in Stress Levels (time frame: 21 days for 30 minutes every day based on a 21-day calendar). 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 NCT04589520, 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 19 Oct 2020.