LonelinessNCT04602455
The Impact of Heartfulness Program on Loneliness in High School Students in the US
A study testing Self-Care Program through Heartfulness in people with Loneliness, run by Heartfulness Institute at 1 site in United States.
Trial summary
This quantitative study assesses the baseline loneliness scores in all the high school students in the US. Assessments at baseline will include the UCLA loneliness scale. The Google form questionnaire will ask the high schoolers for their email address and their parent's email address (if they are under 18). Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Self-Care Program through Heartfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 15 Aug 2020
- 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 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants are High School students in the US and willing to participate in the study
Who cannot join
- Non-English speaking high school students in the US and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.
Trial locations and contacts
1 site in 1 country.
About this study
This quantitative study assesses the baseline loneliness scores in all the high school students in the US. Assessments at baseline will include the UCLA loneliness scale. The Google form questionnaire will ask the high schoolers for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.
Read the detailed description
The specific aims of the study are:
- To assess the current level of loneliness in high school students through the UCLA loneliness scale.
- To assess the beneficial impact of the Heartfulness program on loneliness in high school students in the US.
- Conditions
- Loneliness
- Being tested
- Self-Care Program through Heartfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care Program through HeartfulnessBehavioural
A four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a week webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute.
| Study group | Role | What they receive |
|---|---|---|
| Heartfulness Group | Experimental | Participants were asked to practice relaxation tools for 15 minutes a day using the calendar and HeartBot app, and participate in once a week webinar for 30 minutes during the four weeks. UCLA Loneliness scale was recorded prior to the start of the study and at its end after the duration of 4 weeks. The score was reviewed to see the changes in the loneliness scale. Receives: Behavioral: Self-Care Program through Heartfulness |
| Control Group | No intervention | The control group had no change in their daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the current level of Loneliness
To assess the current level of loneliness in high school students through UCLA loneliness scale.
Measured: Baseline data through the pre-UCLA survey scores
Changes in Loneliness levels
To assess the beneficial impact of Heartfulness program on loneliness in high school students in the US.
Measured: 28 days for 15 minutes every day based on a 28-day calendar
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start23 Jun 2020
- Primary completion28 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartfulness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranjani B Iyer, PhD, Principal investigator, Heartfulness Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602455
- Sponsor's protocol ID
- 2020/05/8
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 26 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Heartfulness Program on Loneliness in High School Students in the US
- ClinicalTrials.gov ID
- NCT04602455
- Acronym / sponsor ID
- 2020/05/8
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Heartfulness InstituteUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 26 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.
This quantitative study assesses the baseline loneliness scores in all the high school students in the US. Assessments at baseline will include the UCLA loneliness scale. The Google form questionnaire will ask the high schoolers for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.
Detailed description
The specific aims of the study are:
- To assess the current level of loneliness in high school students through the UCLA loneliness scale.
- To assess the beneficial impact of the Heartfulness program on loneliness in high school students in the US.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heartfulness Group | Experimental | Behavioral: Self-Care Program through HeartfulnessParticipants were asked to practice relaxation tools for 15 minutes a day using the calendar and HeartBot app, and participate in once a week webinar for 30 minutes during the four weeks. UCLA Loneliness scale was recorded prior to the start of the study and at its end after the duration of 4 weeks. The score was reviewed to see the changes in the loneliness scale. |
| Control Group | No intervention | –The control group had no change in their daily routines. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants are High School students in the US and willing to participate in the study
Key exclusion criteria (1 listed)
- Non-English speaking high school students in the US and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.
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 |
|---|---|---|
| Self-Care Program through HeartfulnessA four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a week webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute. | Behavioural | Heartfulness Group |
Primary outcome
Assess the current level of Loneliness
Time frame: Baseline data through the pre-UCLA survey scores
To assess the current level of loneliness in high school students through UCLA loneliness scale.
Changes in Loneliness levels
Time frame: 28 days for 15 minutes every day based on a 28-day calendar
To assess the beneficial impact of Heartfulness program on loneliness in high school students in the US.
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 26 Oct 2020.
- 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 Self-Care Program through Heartfulness in people with Loneliness, run by Heartfulness Institute 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 26 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?
Assess the current level of Loneliness (time frame: Baseline data through the pre-UCLA survey scores). 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?
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 26 Oct 2020.