Helping Others Toward Positive Emotions in People With Heart Failure

NCT01275742 | Completed

• 2 other identifiers: 5P20NR010679-045P20NR010679
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Heart failure; Depression; Depressive symptoms; Cognitive therapy; Hospitalization; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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).

  Three months to five years

Secondary Outcomes (5)

• Depressive symptoms

  1 week, 3 months, and 6 months

• Health-related quality of life

  1 week, 3 months, and 6 months

• Salivary cortisol

  1 week, 3 months, and 6 months

• No depressive symptom comparison group

  1 week, 3 months, and 6 months

• Salivary vs. serum biomarkers

  Baseline

Study Arms (1)

Usual Care

NO INTERVENTION

Behavioral: Brief Cognitive Therapy Intervention

Interventions

Brief Cognitive Therapy Intervention 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.

Also known as: Cognitive therapy, Cognitive behavioral therapy, Counseling, Nursing intervention

Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Rebecca L. Dekker, PhD, RN, APRN: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Heart Failure; Depression

Interventions

Cognitive Behavioral Therapy; Counseling; Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Investigative Techniques

Study Officials

• Rebecca L Dekker, PhD

  University of Kentucky College of Nursing

  PRINCIPAL INVESTIGATOR

• Elizabeth Tovar, PhD

  University of Kentucky College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

US (1)