FSU Hypertension Self-Care Training Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770756
Recruitment Status : Unknown
Verified July 2015 by Florida State University.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2013
Last Update Posted : July 31, 2015
Information provided by (Responsible Party):
Florida State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Self-Care Training Not Applicable

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Willpower-based Self-care for Hypertension
Study Start Date : August 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Enhancing willpower using active skills
This group will use active tasks such as learning skills using hands to enhance willpower.
Behavioral: Self-Care Training
Experimental: Enhancing willpower using passive tasks
This group will use passive tasks such as taking still postures to enhance willpower.
Behavioral: Self-Care Training

Primary Outcome Measures :
  1. Effects of two forms of self-care training on overall health of adults with hypertension [ Time Frame: 20 weeks from beginning of training sessions ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01770756

United States, Florida
FSU College of Social Work
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Principal Investigator: Amy L Ai, PhD Florida State University

Responsible Party: Florida State University Identifier: NCT01770756     History of Changes
Other Study ID Numbers: FSU-2012.8601
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Florida State University:
High blood pressure
Self care

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases