Helping Others Toward Positive Emotions in People With Heart Failure (HOPE-HF)
This study is currently recruiting participants.
Verified September 2012 by University of Kentucky
Sponsor:
University of Kentucky
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: September 12, 2012
Last verified: September 2012
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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) |
Intervention Details:
-
Behavioral: Brief Cognitive Therapy Intervention
- Cognitive therapy
- Cognitive behavioral therapy
- Counseling
- Nursing 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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275742
Contacts
| Contact: Rebecca L Dekker, PhD | 859-323-0242 | rdekker@uky.edu |
Locations
| United States, Kentucky | |
| University of Kentucky Chandler Medical Center | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Dekker rdekker@uky.edu | |
| Principal Investigator: Rebecca L Dekker, PhD | |
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: | September 12, 2012 |
| 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 Depression Heart Diseases Cardiovascular Diseases Behavioral Symptoms |
ClinicalTrials.gov processed this record on October 18, 2012
