Uncontrolled HypertensionNCT03221114
Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
A study testing Positive Psychological Intervention in people with Uncontrolled Hypertension and Cardiovascular Risk Factor, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension, Cardiovascular Risk Factor
- What is being tested?
- Positive Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hispanics/Latinos recruited from Catholic church sites in Chicago-land area
- aged ≥18
- fluent in English or Spanish with ≥8th grade education
- elevated 24-hour ambulatory blood pressure levels (systolic BP> 140 mmHg and >90 mmHg for diastolic BP).
Who cannot join
- Unavailable for study period; have cognitive impairment denoting dementia
- have severely reduced life expectancy
- are currently enrolled in psychotherapy or take prescribed antidepressants
- history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse
- have severe depression.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Pius V Parish
Chicago, Illinois, 60608
Jose M Santiago, 312-226-6161
About this study
The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.
Read the detailed description
The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.
- Being tested
- Positive Psychological Intervention
- Keywords
- Hispanics/Latinos, Underserved Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychological InterventionBehavioural
Also called Positive Affect Intervention
Our culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychological Intervention | Experimental | Our culturally-tailored Positive Psychology (PP) Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience. Receives: Behavioral: Positive Psychological Intervention |
| Wait list control | No intervention | Receipt after the active treatment group has completed the positive psychological intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks
The device, Vitavue, consists of a wireless microcontroller that connects to a desktop computer running proprietary software when operated in real time connected mode. Alternatively, it can be operated in standalone unconnected mode by logging acquired data to an internal memory storage device. The device contains a number of sensors including ECG single channel amplifier, Multispectral Photodiode to record photo pulse plethysmograms, temperature sensor to measure skin temperature, and an accelerometer to record the level of activity.
Measured: Baseline, 8-, and 12-weeks
Secondary outcomes (4)
Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks
Center for Epidemiological Studies Depression-Scale
Measured: Baseline, 8-, and 12-weeks
Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks
Life Orientation Test-Revised
Measured: Baseline, 8-, and 12-weeks
General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks
General Well-being Schedule
Measured: Baseline, 8-, and 12-weeks
Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks
Life Engagement Test
Measured: Baseline, 8-, and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Oct 2017
- Primary completionSep 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221114
- Sponsor's protocol ID
- 1K01HL130712-01A1
- Status last verified
- Mar 2019
- First submitted
- 14 Jun 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed. If additional outputs result from this research that would be appropriate to share with a wider audience, we will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03221114
- Acronym / sponsor ID
- 1K01HL130712-01A1
- Keywords
- Hispanics/Latinos, Underserved Population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 18 Jul 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.
The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.
Detailed description
The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Positive Psychological Intervention | Experimental | Behavioral: Positive Psychological InterventionOur culturally-tailored Positive Psychology (PP) Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience. |
| Wait list control | No intervention | –Receipt after the active treatment group has completed the positive psychological intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hispanics/Latinos recruited from Catholic church sites in Chicago-land area
- aged ≥18
- fluent in English or Spanish with ≥8th grade education
- elevated 24-hour ambulatory blood pressure levels (systolic BP> 140 mmHg and >90 mmHg for diastolic BP).
Key exclusion criteria (5 listed)
- Unavailable for study period; have cognitive impairment denoting dementia
- have severely reduced life expectancy
- are currently enrolled in psychotherapy or take prescribed antidepressants
- history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse
- have severe depression.
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 |
|---|---|---|
| Positive Psychological InterventionAlso: Positive Affect InterventionOur culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience. | Behavioural | Positive Psychological Intervention |
Primary outcome
Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks
Time frame: Baseline, 8-, and 12-weeks
The device, Vitavue, consists of a wireless microcontroller that connects to a desktop computer running proprietary software when operated in real time connected mode. Alternatively, it can be operated in standalone unconnected mode by logging acquired data to an internal memory storage device. The device contains a number of sensors including ECG single channel amplifier, Multispectral Photodiode to record photo pulse plethysmograms, temperature sensor to measure skin temperature, and an accelerometer to record the level of activity.
4 secondary outcomes
Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks
Time frame: Baseline, 8-, and 12-weeks
Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks
Time frame: Baseline, 8-, and 12-weeks
General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks
Time frame: Baseline, 8-, and 12-weeks
Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks
Time frame: Baseline, 8-, and 12-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: Yes. We will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed. If additional outputs result from this research that would be appropriate to share with a wider audience, we will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychological Intervention in people with Uncontrolled Hypertension and Cardiovascular Risk Factor, run by University of Illinois at Urbana-Champaign 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosalba Hernandez, PhD (217-300-1049, rherna17@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks (time frame: Baseline, 8-, and 12-weeks). 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 20 Mar 2019.