Pre-hypertensionNCT03168789
Tension Tamer Randomized Control Trial
A study testing Tension Tamer (TT) and Lifestyle education program (SPCTL) in people with Pre-hypertension, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To determine eligibility potential subjects will have resting blood pressures (BP) measured on 2 occasions. Pre-hypertensive individuals will be invited to participate in the study. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension
- What is being tested?
- Tension Tamer (TT) and Lifestyle education program (SPCTL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 22 Nov 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-90 years old, male or female, African American (AA) or White;
- Stage 1 or 2 pre-hypertensive (i.e., SBP 120-139/DBP<90) based upon 2 consecutive clinic evaluations;
- Body Mass Index (BMI) 18.5 -45 Kg/m2;
- legally competent;
- able to use a smart phone.
Who cannot join
- failure to meet any inclusion criteria;
- type two diabetes or chronic kidney disease (GFR<50 mL/1.7 m2/min.);
- cancer diagnosis or treatment in past 2 years;
- prior cardiovascular event, congestive heart failure or angina;
- prior or current psychiatric illness;
- ongoing substance abuse (e.g., >21 drinks/week);
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- pharmacologic medications which may influence blood pressure (BP);
- planned pregnancy;
- vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Smartphone Delivered Meditation for BP Control Among Prehypertensives
This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To determine eligibility potential subjects will have resting blood pressures (BP) measured on 2 occasions. Pre-hypertensive individuals will be invited to participate in the study. After informed consent is obtained, subjects will complete baseline visit consisting of a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining 4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.
Read the detailed description
80 stage 1 or 2 pre-hypertensive adults, will be randomly assigned to 2x daily TT at scheduled decreasing doses or enhanced standard of care lifestyle education program delivered via smartphone (SPCTL) for 12 months. Subjects will participate in 5 study visits at baseline/enrollment, 1, 3, 6 , and 12 months
TT subjects will be given the TT app. The app provides instructions on breathing awareness meditation (BAM): focusing upon the moment by sustaining one's attention upon diaphragm movements and related sensations while breathing in a slow, deep, relaxed manner. One learns to passively observe thoughts, images and extraneous sounds without making judgments about them. BAM doesn't involve analysis of historical or recent stressful experiences, but instead centers upon learning to stay in the present moment while meditating. The app will also collect heart rate (HR) values during each session using the phone's camera. The duration of the TT sessions will begin at 15 min., decrease to 10 min., and finally decrease to 5 min. Adherence will be monitored by the receipt of date-stamped heart rate values collected during each meditation session.
SPCTL subjects will be provided Runkeeper app and taught how to record physical activity they perform. Recommended dosage of using SPCTL media and/or app will be that of the TT group. Adherence to SPCTL will be assessed using server file analyses of modules used and activity recorded in Runkeeper.
- Conditions
- Pre-hypertension
- Being tested
- Tension Tamer (TT), Lifestyle education program (SPCTL)
- Keywords
- Breathing Awareness Meditation,
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension Tamer (TT)Behavioural
Tension Tamer is an app that provides training and motivation for breathing awareness meditation (BAM). The app also tracks heart rate values during each session by placing a finger tip over the rear camera.
Lifestyle education program (SPCTL)Behavioural
SPCTL group will use Runkeeper app to log physical activity. They will also receive text messages with short healthy lifestyle tips, and links to media with pamphlets or videos with more in-depth information.
| Study group | Role | What they receive |
|---|---|---|
| Tension Tamer (TT) | Experimental | Breathing Awareness Mediation delivered by smartphone app. Receives: Behavioral: Tension Tamer (TT) |
| Lifestyle education program (SPCTL) | Active comparator | Healthy lifestyle education provided by text messages and links to media. Runkeeper app to log physical activity. Receives: Behavioral: Lifestyle education program (SPCTL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting BP
Resting SBP reduction target -7 mmHg.
Measured: 12 months
Secondary outcomes (1)
Ambulatory SBP
24-hr SBP reduction target -4 mmHg.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Oct 2016
- Primary completion22 Nov 2019
- Study completion22 Nov 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 Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Treiber, Medical University of South Carolina
- Investigators
- Frank A Treiber, PhD, Principal investigator, MUSC College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168789
- Sponsor's protocol ID
- Pro00020894
- Status last verified
- Jan 2020
- First submitted
- 25 May 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams ZW, Sieverdes JC, Brunner-Jackson B, Mueller M, Chandler J, Diaz V, Patel S, Sox LR, Wilder S, Treiber FA. Meditation smartphone application effects on prehypertensive adults' blood pressure: Dose-response feasibility trial. Health Psychol. 2018 Sep;37(9):850-860. doi: 10.1037/hea0000584. Epub 2018 Jul 16.
PubMed 30010353
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Delivered Meditation for BP Control Among Prehypertensives
- ClinicalTrials.gov ID
- NCT03168789
- Acronym / sponsor ID
- Pro00020894
- Conditions
- Pre-hypertension
- Keywords
- Breathing Awareness Meditation,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 30 May 2017 (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 study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To determine eligibility potential subjects will have resting blood pressures (BP) measured on 2 occasions. Pre-hypertensive individuals will be invited to participate in the study. After informed consent is obtained, subjects will complete baseline visit consisting of a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining 4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.
Detailed description
80 stage 1 or 2 pre-hypertensive adults, will be randomly assigned to 2x daily TT at scheduled decreasing doses or enhanced standard of care lifestyle education program delivered via smartphone (SPCTL) for 12 months. Subjects will participate in 5 study visits at baseline/enrollment, 1, 3, 6 , and 12 months
TT subjects will be given the TT app. The app provides instructions on breathing awareness meditation (BAM): focusing upon the moment by sustaining one's attention upon diaphragm movements and related sensations while breathing in a slow, deep, relaxed manner. One learns to passively observe thoughts, images and extraneous sounds without making judgments about them. BAM doesn't involve analysis of historical or recent stressful experiences, but instead centers upon learning to stay in the present moment while meditating. The app will also collect heart rate (HR) values during each session using the phone's camera. The duration of the TT sessions will begin at 15 min., decrease to 10 min., and finally decrease to 5 min. Adherence will be monitored by the receipt of date-stamped heart rate values collected during each meditation session.
SPCTL subjects will be provided Runkeeper app and taught how to record physical activity they perform. Recommended dosage of using SPCTL media and/or app will be that of the TT group. Adherence to SPCTL will be assessed using server file analyses of modules used and activity recorded in Runkeeper.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension Tamer (TT) | Experimental | Behavioral: Tension Tamer (TT)Breathing Awareness Mediation delivered by smartphone app. |
| Lifestyle education program (SPCTL) | Active comparator | Behavioral: Lifestyle education program (SPCTL)Healthy lifestyle education provided by text messages and links to media. Runkeeper app to log physical activity. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-90 years old, male or female, African American (AA) or White;
- Stage 1 or 2 pre-hypertensive (i.e., SBP 120-139/DBP<90) based upon 2 consecutive clinic evaluations;
- Body Mass Index (BMI) 18.5 -45 Kg/m2;
- legally competent;
- able to use a smart phone.
Key exclusion criteria (9 listed)
- failure to meet any inclusion criteria;
- type two diabetes or chronic kidney disease (GFR<50 mL/1.7 m2/min.);
- cancer diagnosis or treatment in past 2 years;
- prior cardiovascular event, congestive heart failure or angina;
- prior or current psychiatric illness;
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 |
|---|---|---|
| Tension Tamer (TT)Tension Tamer is an app that provides training and motivation for breathing awareness meditation (BAM). The app also tracks heart rate values during each session by placing a finger tip over the rear camera. | Behavioural | Tension Tamer (TT) |
| Lifestyle education program (SPCTL)SPCTL group will use Runkeeper app to log physical activity. They will also receive text messages with short healthy lifestyle tips, and links to media with pamphlets or videos with more in-depth information. | Behavioural | Lifestyle education program (SPCTL) |
Primary outcome
Resting BP
Time frame: 12 months
Resting SBP reduction target -7 mmHg.
1 secondary outcome
Ambulatory SBP
Time frame: 12 months
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 14 Jan 2020.
- Derived from this study: PubMed 30010353Adams ZW, Sieverdes JC, Brunner-Jackson B, Mueller M, Chandler J, Diaz V, Patel S, Sox LR, Wilder S, Treiber FA. Meditation smartphone application effects on prehypertensive adults' blood pressure: Dose-response feasibility trial. Health Psychol. 2018 Sep;37(9):850-860. doi: 10.1037/hea0000584. Epub 2018 Jul 16.
- 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.
Frank A Treiber, PhD principal investigator
MUSC College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension Tamer (TT) and Lifestyle education program (SPCTL) in people with Pre-hypertension, run by Medical University of South Carolina 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 5 inclusion and 9 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 14 Jan 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?
Resting BP (time frame: 12 months). 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 NCT03168789, 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 14 Jan 2020.