Helping Others Toward Positive Emotions in People With Heart Failure

Rebecca L. Dekker, PhD, RN, APRN180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Heart Failure

Interventions

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admitted to the hospital with a primary or secondary diagnosis of congestive heart failure OR admitted to the hospital for cardiac reasons and has a history of chronic heart failure * American College of Cardiology/ American Heart Association Stage C HF * 21 years or older Exclusion Criteria: * Co-existing terminal illness likely to be fatal within the next 12 months * End-stage HF (defined as American College of Cardiology Stage D HF) * Cognitive impairment that precludes the ability to give informed consent * Active suicidality (defined choosing option 1, 2 or 3 on Item 9 of the PHQ-9) * History of the death of a spouse or child within the past month * History of psychotic illness or bipolar illness * Current alcohol dependence or other substance abuse * Non-English speaking or possessing any other communication barrier

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Helping Others Toward Positive Emotions in People With Heart Failure

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes