This trial is active, not recruiting.

Condition heart failure
Treatment brief cognitive therapy intervention
Sponsor University of Kentucky
Collaborator National Institute of Nursing Research (NINR)
Start date January 2011
End date January 2016
Trial size 180 participants
Trial identifier NCT01275742, 5P20NR010679, 5P20NR010679-04


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
brief cognitive therapy intervention Cognitive therapy
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.

Primary Outcomes

Cardiac event-free survival
time frame: Three months to five years

Secondary Outcomes

Depressive symptoms
time frame: 1 week, 3 months, and 6 months
Health-related quality of life
time frame: 1 week, 3 months, and 6 months
Salivary cortisol
time frame: 1 week, 3 months, and 6 months
No depressive symptom comparison group
time frame: 1 week, 3 months, and 6 months
Salivary vs. serum biomarkers
time frame: Baseline

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
Principal investigator Rebecca L Dekker, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of Kentucky.