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Completed

NCT Number: NCT01275742

Helping Others Toward Positive Emotions in People With Heart Failure

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.

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Key information

Conditions

Heart Failure Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cognitive therapy, Cognitive behavioral therapy, Counseling, Nursing intervention

Primary outcomes

  1. Cardiac event-free survival

    Time frame: Three months to five years

    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).

Secondary outcomes

  1. Depressive symptoms

    Time frame: 1 week, 3 months, and 6 months

    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).

  2. Health-related quality of life

    Time frame: 1 week, 3 months, and 6 months

    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).

  3. Salivary cortisol

    Time frame: 1 week, 3 months, and 6 months

    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).

  4. No depressive symptom comparison group

    Time frame: 1 week, 3 months, and 6 months

    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.

  5. Salivary vs. serum biomarkers

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Rebecca L. Dekker, PhD, RN, APRN

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure

Acronym: HOPE-HF

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2011
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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