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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01275742
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure Behavioral: Brief Cognitive Therapy Intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
Actual Study Start Date : January 2011
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275742


Locations
United States, Kentucky
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Rebecca L. Dekker, PhD, RN, APRN
National Institute of Nursing Research (NINR)
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

Responsible Party: Rebecca L. Dekker, PhD, RN, APRN, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01275742     History of Changes
Other Study ID Numbers: 5P20NR010679-04 ( U.S. NIH Grant/Contract )
5P20NR010679 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by Rebecca L. Dekker, PhD, RN, APRN, University of Kentucky:
Heart failure
Depression
Depressive symptoms
Cognitive therapy
Hospitalization
Quality of life

Additional relevant MeSH terms:
Heart Failure
Depression
Heart Diseases
Cardiovascular Diseases
Behavioral Symptoms