Helping Others Toward Positive Emotions in People With Heart Failure (HOPE-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Therapy Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Depression, Depressive symptoms, Cognitive therapy, Hospitalization, Quality of life
Eligibility 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
Sites / Locations
- University of Kentucky Chandler Medical Center
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Depressive symptoms
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
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
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
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
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.
Full Information
NCT ID
NCT01275742
First Posted
January 10, 2011
Last Updated
August 9, 2017
Sponsor
Rebecca L. Dekker, PhD, RN, APRN
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01275742
Brief Title
Helping Others Toward Positive Emotions in People With Heart Failure
Acronym
HOPE-HF
Official Title
Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecca L. Dekker, PhD, RN, APRN
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Depression, Depressive symptoms, Cognitive therapy, Hospitalization, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Therapy Intervention
Other Intervention Name(s)
Cognitive therapy, Cognitive behavioral therapy, Counseling, Nursing intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac event-free survival
Description
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).
Time Frame
Three months to five years
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
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).
Time Frame
1 week, 3 months, and 6 months
Title
Health-related quality of life
Description
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).
Time Frame
1 week, 3 months, and 6 months
Title
Salivary cortisol
Description
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).
Time Frame
1 week, 3 months, and 6 months
Title
No depressive symptom comparison group
Description
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.
Time Frame
1 week, 3 months, and 6 months
Title
Salivary vs. serum biomarkers
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Dekker, PhD
Organizational Affiliation
University of Kentucky College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Tovar, PhD
Organizational Affiliation
University of Kentucky College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
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