Impact of a Psychological Biofeedback-Relaxation Intervention on Clinical, Physical and Psychological Outcomes in Patients With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra Moser, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00255931
First received: November 16, 2005
Last updated: June 2, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine the effect of biofeedback-relaxation combined with cognitive behavioral therapy on clinical, physical and psychological outcomes in patients with heart failure.


Condition Intervention Phase
Heart Failure
Behavioral: Cognitive Behavioral Therapy
Behavioral: Attention Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biobehavioral Intervention in Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Examination of the impact of biofeedback-relaxation training on HF patient outcomes. [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived Control [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]
  • Skin Temperature [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]
  • Heart Rate Variability [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]
  • Plasma Norepinephrine [ Time Frame: Baseline, 3-, and 12-Months ] [ Designated as safety issue: No ]

Enrollment: 380
Study Start Date: July 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy and Relaxation/biofeedback
Placebo Comparator: 2 Behavioral: Attention Placebo
Untrained relaxation
No Intervention: 3
Usual Care

Detailed Description:

The long-term aim of this program of research is to improve physical and psychological health outcomes of adults with heart failure (HF). The specific aims of the randomized, controlled clinical trial are to test the effects of biofeedback-relaxation therapy in HF patients on rehospitalizations, cardiac mortality and quality of life, and on the secondary end-points of perceived control, anxiety, depression, skin temperature, plasma norepinephrine levels, and heart rate variability (HRV).

In the 1990s, HF emerged as a significant public health threat and reached epidemic proportions. Heart failure incidence and prevalence are expected to increase worldwide, and its impact to worsen dramatically. Individuals with HF suffer incapacitating physical symptoms, emotional distress, impaired quality of life, repeated rehospitalizations, and premature death. To combat the rising HF epidemic, it is crucial that researchers study new strategies to improve outcomes. Despite its potential as an effective partner to drug therapy, the role of nonpharmacologic intervention in HF management has received relatively little attention.

One may argue that drug therapy is effective enough that resources need not be expended on research of nonpharmacologic therapies. However, three points argue against this stance. First, despite substantial advances made in HF treatment with drug therapy, morbidity and mortality remain unacceptably high. As Kannel states, "innovations in treatment of...HF have thus far made a disappointingly small improvement in its…outlook". Second, although drug therapy frequently provides significant improvement in symptoms and functional ability, quality of life may not improve. This outcome is important for patients with HF because poorer quality of life independently predicts morbidity and mortality. Third, nonpharmacologic strategies can have effect sizes for important HF outcomes (e.g., rehospitalization rates/mortality and quality of life) that are similar to those seen with drug therapy. Recent studies demonstrated these therapies substantially improve outcomes beyond the level seen in the same patients with pharmacologic therapy.

Biofeedback-relaxation therapy is an innovative and promising nonpharmacologic strategy. An optimally effective treatment should have a beneficial effect on both pathophysiological and psychological manifestations of the target condition. This goal is especially important for a condition like HF, which has a profoundly negative impact on physical and psychological function. Hallmark pathophysiology in HF includes intense neurohumoral activation, initiated and sustained by the sympathetic nervous system (SNS), with marked vasoconstriction. Adverse psychological manifestations of chronic HF include feelings of loss of control, anxiety and depression. Both neurohumoral activation and the psychological consequences of HF contribute to poor quality of life, frequent HF hospitalizations, and increased mortality. As shown in the model in Figure 1, biofeedback-relaxation therapy takes three complementary, but separate pathways to improve outcomes. This biobehavioral therapy decreases SNS activation (as reflected by HRV and plasma norepinephrine), produces stress reduction (as reflected by changes in perceived control, anxiety and depression), and results in vasodilation (as reflected by skin temperature). Biofeedback-relaxation therapy can have a powerful influence because of these separate, yet complementary effects. For example, SNS activation is directly decreased by biofeedback-relaxation therapy, but also indirectly as a result of stress reduction with increased control, and decreased anxiety and depression. As a result of its physical and psychological effects, biofeedback-relaxation could have a clinically meaningful impact on rehospitalizations, survival and quality of life. For these reasons, biofeedback-relaxation may be an effective adjunct to pharmacologic therapy in the management of HF. Thus, the purpose of the proposed research is to examine the impact of biofeedback-relaxation training on HF patient outcomes.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed diagnosis of chronic advanced HF. Other sample selection criteria include: 1) on stable doses of HF medication for at least one month; and 2) not referred for heart transplantation.

Exclusion Criteria:

  • Patients will be excluded if they have: 1) valvular heart disease (as a primary cause of their HF; can have it if the primary cause is ischemic, hypertensive or idiopathic), peripartum heart failure, myocarditis; 2) history of cerebral vascular accident (CVA) within previous 3 months or major stroke sequelae; 3) history of major extremity vascular problems; 4) recent (within 3 months) myocardial infarction (MI); 5) coexisting terminal illness; 6) systolic blood pressure less than 80 mmHg; or 7) previous experience with biofeedback, relaxation .
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255931

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40535
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Debra Moser, DNSc, RN University of Kentucky
  More Information

No publications provided

Responsible Party: Debra Moser, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT00255931     History of Changes
Other Study ID Numbers: 8567, R01NR008567, R01 NR008567-01A1
Study First Received: November 16, 2005
Last Updated: June 2, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Kentucky:
Heart Failure
Biofeedback-Relaxation
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014