Impact of a Psychological Biofeedback-Relaxation Intervention on Clinical, Physical and Psychological Outcomes in Patients With Heart Failure
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|ClinicalTrials.gov Identifier: NCT00255931|
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : June 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Cognitive Behavioral Therapy Behavioral: Attention Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Biobehavioral Intervention in Heart Failure|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy and Relaxation/biofeedback
|Placebo Comparator: 2||
Behavioral: Attention Placebo
No Intervention: 3
- Examination of the impact of biofeedback-relaxation training on HF patient outcomes. [ Time Frame: Baseline, 3-, and 12-Months ]
- Perceived Control [ Time Frame: Baseline, 3-, and 12-Months ]
- Anxiety [ Time Frame: Baseline, 3-, and 12-Months ]
- Depression [ Time Frame: Baseline, 3-, and 12-Months ]
- Skin Temperature [ Time Frame: Baseline, 3-, and 12-Months ]
- Heart Rate Variability [ Time Frame: Baseline, 3-, and 12-Months ]
- Plasma Norepinephrine [ Time Frame: Baseline, 3-, and 12-Months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00255931
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40535|
|Principal Investigator:||Debra Moser, DNSc, RN||University of Kentucky|