Helping Others Toward Positive Emotions in People With Heart Failure

NCT ID: NCT01275742

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-08-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Group Type: NO_INTERVENTION

Brief Cognitive Therapy Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive therapy; Cognitive behavioral therapy; Counseling; Nursing intervention

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Rebecca L. Dekker, PhD, RN, APRN

OTHER

Sponsor Role: lead

Responsible Party

Rebecca L. Dekker, PhD, RN, APRN

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rebecca L Dekker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky College of Nursing

Elizabeth Tovar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky College of Nursing

Locations

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

5P20NR010679

Identifier Type: NIH

Identifier Source: secondary_id

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5P20NR010679-04

Identifier Type: NIH

Identifier Source: org_study_id

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