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

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ClinicalTrials.gov Identifier: NCT01275742
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Rebecca L. Dekker, PhD, RN, APRN, University of Kentucky

Tracking Information
First Submitted Date  ICMJE January 10, 2011
First Posted Date  ICMJE January 12, 2011
Last Update Posted Date August 11, 2017
Actual Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Helping Others Toward Positive Emotions in People With Heart Failure
Official Title  ICMJE Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE 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
Study Arms  ICMJE No Intervention: Usual Care
Intervention: Behavioral: Brief Cognitive Therapy Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 11, 2011)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01275742
Other Study ID Numbers  ICMJE 5P20NR010679-04( U.S. NIH Grant/Contract )
5P20NR010679 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca L. Dekker, PhD, RN, APRN, University of Kentucky
Study Sponsor  ICMJE Rebecca L. Dekker, PhD, RN, APRN
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Rebecca L Dekker, PhD University of Kentucky College of Nursing
Principal Investigator: Elizabeth Tovar, PhD University of Kentucky College of Nursing
PRS Account University of Kentucky
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP