Clinical trial NCT01275742: Helping Others Toward Positive Emotions in People With Heart Failure
Official title: Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Depression
Depressive symptoms
Cognitive therapy
Hospitalization
Quality of life
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-01-12
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiac event-free survival
timeFrame: Three months to five years
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 1 week, 3 months, and 6 months
measure: Health-related quality of life
timeFrame: 1 week, 3 months, and 6 months
measure: Salivary cortisol
timeFrame: 1 week, 3 months, and 6 months
measure: No depressive symptom comparison group
timeFrame: 1 week, 3 months, and 6 months
measure: Salivary vs. serum biomarkers
timeFrame: Baseline
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky College of Nursing
name: Rebecca L Dekker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky College of Nursing
name: Elizabeth Tovar, PhD
role: PRINCIPAL_INVESTIGATOR
References: