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Helping Others Toward Positive Emotions in People With Heart Failure (HOPE-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rebecca L. Dekker, PhD, RN, APRN, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01275742
First received: January 10, 2011
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Brief Cognitive Therapy Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Cardiac event-free survival [ Time Frame: Three months to five years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Depressive symptoms [ Time Frame: 1 week, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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).

  • Health-related quality of life [ Time Frame: 1 week, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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).

  • Salivary cortisol [ Time Frame: 1 week, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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).

  • No depressive symptom comparison group [ Time Frame: 1 week, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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.

  • Salivary vs. serum biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 180
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Behavioral: 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.
Other Names:
  • Cognitive therapy
  • Cognitive behavioral therapy
  • Counseling
  • Nursing intervention

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275742

Locations
United States, Kentucky
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Rebecca L Dekker, PhD University of Kentucky College of Nursing
Principal Investigator: Elizabeth Tovar, PhD University of Kentucky College of Nursing
  More Information

No publications provided

Responsible Party: Rebecca L. Dekker, PhD, RN, APRN, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01275742     History of Changes
Other Study ID Numbers: 5P20NR010679-04, 5P20NR010679
Study First Received: January 10, 2011
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Kentucky:
Heart failure
Depression
Depressive symptoms
Cognitive therapy
Hospitalization
Quality of life

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014