An interventional study of Brief Cognitive Therapy Intervention in Heart Failure, sponsored by Rebecca L. Dekker, PhD, RN, APRN. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-08-11.
Sponsored by Rebecca L. Dekker, PhD, RN, APRN · Not applicable, Interventional, and Treatment
Heart failure (HF) affects 5 million people in the US and is the most common cause of hospitalization in elderly adults. One-third of patients who are hospitalized with HF have major depression. Depressed HF patients have double the rates of morbidity and/or mortality and worse health-related quality of life than non-depressed HF patients. The investigators previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may improve short-term cardiac survival among depressed hospitalized HF patients compared to non-depressed HF patients who received usual care. Therefore, the investigators will conduct a larger study to evaluate the effects of the intervention on longer cardiac event-free survival, symptoms of depression, health-related quality of life, and stress levels in patients with HF. The investigators hypothesize that patients in the intervention group will experience longer cardiac event-free survival, lower levels of depressive symptom, better health-related quality of life, and lower salivary cortisol levels at follow-up than patients who receive usual care.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 180 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Rebecca L. Dekker, PhD, RN, APRN as lead sponsor.
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Exclusion Criteria:
Behavioral: Brief Cognitive Therapy Intervention
The intervention group will receive an individual, 30 minute, scripted cognitive therapy session. This intervention will be delivered by an Advanced Practice Registered Nurse or a trained research nurse. An iPad will guide the outline of the intervention. The nurse will discuss depression in heart disease and the connection between thoughts, emotions, and behaviors. The nurse will ask the patient to describe a recent stressful experience and discuss thoughts that the patient has been experiencing. Two techniques for challenging negative thinking will be introduced to the patient: thought stopping and affirmations. The nurse will ask the patient to practice these techniques at home. After the patient has practiced both techniques, the nurse will leave the patient with a booklet with the intervention. At 1-2 weeks, the nurse will administer a booster session over the phone. This session will last 10-15 minutes and will reinforce the techniques learned during the brief CT intervention.
Also known as: Cognitive therapy, Cognitive behavioral therapy, Counseling, Nursing intervention
Cardiac event-free survival
To compare cardiac event-free survival at 3 months, 6 months, and up to five years between patients with HF and depressive symptoms who receive a brief cognitive therapy intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
Time frame: Three months to five years
Depressive symptoms
Compare depressive symptoms at 1-week, 3 months, and 6 months between patients with HF and depressive symptoms who receive a brief CT intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
Time frame: 1 week, 3 months, and 6 months
Health-related quality of life
Compare health-related quality of life at 1-week, 3 months, and 6 months between patients with HF and depressive symptoms who receive a brief CT intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
Time frame: 1 week, 3 months, and 6 months
Salivary cortisol
Compare salivary cortisol at 1-week, 3 months, and 6 months between patients with HF and depressive symptoms who receive a brief CT intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
Time frame: 1 week, 3 months, and 6 months
No depressive symptom comparison group
Compare cardiac event-free survival, depressive symptoms, health-related quality of life, and salivary cortisol levels between the depressive symptom intervention group and patients with HF and no depressive symptoms who receive usual care (no depressive symptom group) at 1-week, 3 months, and 6 months.
Time frame: 1 week, 3 months, and 6 months
Salivary vs. serum biomarkers
Compare levels of salivary cortisol, BNP, CRP and IL-6 at baseline between patients with and without depressive symptoms, and determine whether the salivary measures of BNP, CRP, and IL-6 are correlated with serum measurement of these biomarkers.
Time frame: Baseline
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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