AnxietyNCT05874232
The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
A study testing Self-Care Program through Heartfulness in people with Anxiety and Satisfaction With Life, run by Heartfulness Institute at 1 site in United States.
Trial summary
This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Satisfaction With Life, 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
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to 3 Jul 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 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study.
Who cannot join
- Non-English speaking high school students and staff 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 anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff 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 aim of this study is to assess changes in scores measuring symptoms of anxiety using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA Loneliness Scale (Version 3).
- Conditions
- Anxiety, Satisfaction With Life, Loneliness
- Being tested
- Self-Care Program through Heartfulness
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
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 weekly 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 weekly webinar for 30 minutes during the four weeks. The GAD, SWLS, and UCLA Loneliness scale was recorded prior to the start of the study, at the end of the program at Week 4, and after the duration of 4 weeks at Week 8. The score was reviewed to see the changes in anxiety, satisfaction with life, and 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 Anxiety
To assess the current level of anxiety in high school students and staff through GAD Scale.
Measured: Week 0
Changes level of Anxiety
To assess the beneficial impact of Heartfulness program on anxiety in high school students and staff.
Measured: Week 4 and Week 8
Assess the current level of Satisfaction with Life
To assess the current level of satisfaction with life in high school students and staff through SWLS Scale.
Measured: Week 0
Changes level of Satisfaction with Life
To assess the beneficial impact of Heartfulness program on satisfaction with life in high school students and staff.
Measured: Week 4 and Week 8
Assess the current level of Loneliness
To assess the current level of loneliness in high school students and staff through UCLA loneliness scale.
Measured: Week 0
Changes in Loneliness levels
To assess the beneficial impact of Heartfulness program on loneliness in high school students and staff.
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start3 Feb 2022
- Primary completion3 Jun 2022
- Study completion3 Jul 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 AnxietyStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartfulness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874232
- Sponsor's protocol ID
- 2022/01/2
- Status last verified
- May 2023
- First submitted
- 4 Apr 2023
- Last updated
- 24 May 2023
- 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 P, Iyer L, Carter N, Iyer R, Stirling A, Priya L, Sriraman U. Self-Care Program as a Tool for Alleviating Anxiety and Loneliness and Promoting Satisfaction With Life in High School Students and Staff: Randomized Survey Study. JMIR Form Res. 2024 Sep 30;8:e56355. doi: 10.2196/56355.
PubMed 39047180
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
- ClinicalTrials.gov ID
- NCT05874232
- Acronym / sponsor ID
- 2022/01/2
- Conditions
- Anxiety, Satisfaction With Life, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Heartfulness InstituteUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 24 May 2023 (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 anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff 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 aim of this study is to assess changes in scores measuring symptoms of anxiety using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA Loneliness Scale (Version 3).
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 weekly webinar for 30 minutes during the four weeks. The GAD, SWLS, and UCLA Loneliness scale was recorded prior to the start of the study, at the end of the program at Week 4, and after the duration of 4 weeks at Week 8. The score was reviewed to see the changes in anxiety, satisfaction with life, and loneliness scale. |
| Control Group | No intervention | –The control group had no change in their daily routines. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study.
Key exclusion criteria (1 listed)
- Non-English speaking high school students and staff 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 weekly 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 Anxiety
Time frame: Week 0
To assess the current level of anxiety in high school students and staff through GAD Scale.
Changes level of Anxiety
Time frame: Week 4 and Week 8
To assess the beneficial impact of Heartfulness program on anxiety in high school students and staff.
Assess the current level of Satisfaction with Life
Time frame: Week 0
To assess the current level of satisfaction with life in high school students and staff through SWLS Scale.
Changes level of Satisfaction with Life
Time frame: Week 4 and Week 8
To assess the beneficial impact of Heartfulness program on satisfaction with life in high school students and staff.
Assess the current level of Loneliness
Time frame: Week 0
To assess the current level of loneliness in high school students and staff through UCLA loneliness scale.
Changes in Loneliness levels
Time frame: Week 4 and Week 8
To assess the beneficial impact of Heartfulness program on loneliness in high school students and staff.
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 24 May 2023.
- Derived from this study: PubMed 39047180Iyer P, Iyer L, Carter N, Iyer R, Stirling A, Priya L, Sriraman U. Self-Care Program as a Tool for Alleviating Anxiety and Loneliness and Promoting Satisfaction With Life in High School Students and Staff: Randomized Survey Study. JMIR Form Res. 2024 Sep 30;8:e56355. doi: 10.2196/56355.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anxiety and Satisfaction With Life, 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 24 May 2023. 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 Anxiety (time frame: Week 0). The study lists 6 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 NCT05874232, 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 24 May 2023.