Hypertension: Prediction of Biofeedback Success

NCT00026065 | Completed Phase 1

• 1 other identifier: R01AT000310-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular disease and its associated complications. More persons are turning to alternative medicine to deal with their health problems. Biofeedback may reduce blood pressure and/or allow the reduction of antihypertensive medications in some patients, while having no adverse effects. Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical to be able to predict which patients with essential hypertension are most likely to lower his/her blood pressure using these techniques. This research proposes to test three different means of predicting whether a hypertensive subject will or will not be successful in lowering his/her blood pressure using biofeedback. Sixty hypertensive subjects will be studied over a three-year period. The results of this study will enable those caring for hypertensive persons to recommend biofeedback in an individualized way, thereby promoting adherence.

Conditions

Essential Hypertension

Keywords

Hypertension; BIofeedback; Non-pharmacological treatment; Prediction

Interventions

Biofeedback BEHAVIORAL

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* essential hypertension * stages 1 or 2 * not taking beta blockers or central acting alpha agonists * permission from primary care provider

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of Florida College of Nursing

Gainesville, Florida, 32610, United States

Location

Related Publications (3)

• Yucha CB. Ambulatory blood pressure monitoring: measurement implications for research. J Nurs Meas. 2001 Spring-Summer;9(1):49-59.

  PMID: 11469141 BACKGROUND

• Yucha CB, Clark L, Smith M, Uris P, LaFleur B, Duval S. The effect of biofeedback in hypertension. Appl Nurs Res. 2001 Feb;14(1):29-35. doi: 10.1053/apnr.2001.21078.

  PMID: 11172227 BACKGROUND

• Weaver MT, McGrady A. A provisional model to predict blood pressure response to biofeedback-assisted relaxation. Biofeedback Self Regul. 1995 Sep;20(3):229-40. doi: 10.1007/BF01474515.

  PMID: 7495917 BACKGROUND

Related Links

• Association for Applied Psychophysiology and Biofeedback

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Carolyn B Yucha, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: November 12, 2001
• Study Start: February 1, 2000
• Study Completion: March 1, 2006
• Last Updated: October 1, 2007

Record last verified: 2006-08

Locations

US (1)