This trial is active, not recruiting.

Condition hypertension
Treatment self-care training
Sponsor Florida State University
Start date August 2012
End date June 2016
Trial size 40 participants
Trial identifier NCT01770756, FSU-2012.8601


The purpose of this study is to compare the effectiveness of two forms of self-care training on the overall health of adults with hypertension.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
This group will use active tasks such as learning skills using hands to enhance willpower.
self-care training
This group will use passive tasks such as taking still postures to enhance willpower.
self-care training

Primary Outcomes

Effects of two forms of self-care training on overall health of adults with hypertension
time frame: 20 weeks from beginning of training sessions

Eligibility Criteria

Male or female participants at least 25 years old.

Inclusion Criteria: - Clinical diagnosis of hypertension - Age 25 or older Exclusion Criteria: - Pregnancy - Participation in other clinical trials or drug/behavioral treatment - Previously participated in any other clinical trials/training on health-related behavior (tai-chi, yoga, nutritional education, yoga class) - Kidney disease - Cancer/chemotherapy, advanced HIV/AIDS, severe liver disease - Severe ischemic heart disease (unstable angina, hospitalization for heart attack, coronary revascularization) - Congestive heart failure - Severe inflammatory/rheumatologic disorders (severe arthritis) - Severe mental health diagnosis such as schizophrenia or bi-polar disorder - Occurrence of any neurological disorders such as stroke or dementia - Addicted to any legal/illegal drugs or alcohol without at least 1 year of sobriety - Any infectious conditions such as pneumonia, traumatic wound, or surgery that may cause inflammation in the past 14 days

Additional Information

Official title Improving the Willpower-based Self-care for Hypertension
Principal investigator Amy L Ai, PhD
Description The FSU College of Social Work and the Department of Psychology are seeking adults age 25 and older with a clinical diagnosis of hypertension for a randomized trial using willpower to manage high blood pressure. Voluntary participants will complete three phases: baseline, intervention, and post-treatment. Baseline phase includes a preliminary phone screening, fasting blood draw, physiological test (measuring heart rate variability, chest compression, etc.), and a psychosocial inventory. Intervention phase includes 8 weeks of once weekly trainings (approximately one hour long) to be held on a weekday evening. Participants will be randomly assigned to one of the two willpower groups and will be asked to rehearse the willpower method at least once daily for 30 minutes during these 8 weeks. Post-treatment phase includes two follow-up booster sessions (at week 12 and week 16) for refreshing willpower techniques, a follow-up fasting blood draw, a physiological test, and a psychosocial inventory. Participation is completely voluntary and confidential. Volunteers completing each of the phases will be compensated $100 for their time. If someone is interested in participating, they should call our office at 850-645-0247 or email fsuwillpower@gmail.com.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Florida State University.