Heart FailureHOPE-HFNCT01275742
Helping Others Toward Positive Emotions in People With Heart Failure
A study testing Brief Cognitive Therapy Intervention in people with Heart Failure, run by Rebecca L. Dekker, PhD, RN, APRN at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Brief Cognitive Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
About this study
Official title: Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
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.
- Conditions
- Heart Failure
- Being tested
- Brief Cognitive Therapy Intervention
- Keywords
- Heart failure, Depression, Depressive symptoms, Cognitive therapy, Hospitalization, Quality of life
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Therapy InterventionBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described Receives: Behavioral: Brief Cognitive Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Three months to five years
Secondary outcomes (5)
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).
Measured: 1 week, 3 months, and 6 months
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).
Measured: 1 week, 3 months, and 6 months
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).
Measured: 1 week, 3 months, and 6 months
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebecca L. Dekker, PhD, RN, APRN
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Rebecca L. Dekker, PhD, RN, APRN, University of Kentucky
- Investigators
- Rebecca L Dekker, PhD, Principal investigator, University of Kentucky College of NursingElizabeth Tovar, PhD, Principal investigator, University of Kentucky College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275742
- Sponsor's protocol ID
- 5P20NR010679-04
- Other IDs
- 5P20NR010679
- Acronym
- HOPE-HF
- Status last verified
- Aug 2017
- First submitted
- 10 Jan 2011
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01275742
- Acronym / sponsor ID
- HOPE-HF / 5P20NR010679-04
- Conditions
- Heart Failure
- Keywords
- Heart failure, Depression, Depressive symptoms, Cognitive therapy, Hospitalization, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rebecca L. Dekker, PhD, RN, APRNUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2011 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | Behavioral: Brief Cognitive Therapy Intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Cognitive Therapy InterventionAlso: Cognitive therapy, Cognitive behavioral therapy, Counseling, Nursing interventionThe 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. | Behavioural | Usual Care |
Primary outcome
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).
5 secondary outcomes
Depressive symptoms
Time frame: 1 week, 3 months, and 6 months
Health-related quality of life
Time frame: 1 week, 3 months, and 6 months
Salivary cortisol
Time frame: 1 week, 3 months, and 6 months
No depressive symptom comparison group
Time frame: 1 week, 3 months, and 6 months
Salivary vs. serum biomarkers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca L Dekker, PhD principal investigator
University of Kentucky College of Nursing
Elizabeth Tovar, PhD principal investigator
University of Kentucky College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Therapy Intervention in people with Heart Failure, run by Rebecca L. Dekker, PhD, RN, APRN at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac event-free survival (time frame: Three months to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.