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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL091918 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart failure self-care education is superior to "usual care" for depression.
Comorbid depression is common in heart failure, but little is known about how to treat it. This randomized, controlled, efficacy trial will compare cognitive behavior therapy (CBT) to usual care (UC) for depression in heart failure. CBT will be integrated with an intervention to improve heart failure self-care, because depression and inadequate self-care are thought to be interrelated problems. It will also be integrated with clinical attention to primary caregiver stress. Basic heart failure education will be provided to all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavior Therapy | Active Comparator |
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| Usual Care | Other | Participants who are randomly assigned to usual care will receive whatever treatment (if any) for depression their own physician may prescribe. In most cases, treatment (if any is provided) is likely to consist of a serotonin reuptake inhibitor (SSRI) antidepressant such as sertraline or citalopram. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | CBT utilizes a variety of strategies and techniques to modify cognitions and behaviors that contribute to depression such as behavioral activation; identifying and challenging distressing thoughts, beliefs, and attitudes; and systematic problem-solving. In this trial, CBT will be integrated with an intervention aimed at improving heart failure self-care, and with attention to primary caregiver stress. The CBT sessions will usually last about 50 minutes and will be scheduled weekly for up to 6 months, with additional maintenance contacts after that. The frequency of sessions will be tapered prior to 6 months if the participant meets the study criteria for depression remission and has acquired relapse-prevention skills. |
| Measure | Description | Time Frame |
|---|---|---|
| BDI-II score at 6 months | Baseline, 3 months, 6 months, 9 months , 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-care of Heart Failure Index | Baseline, 3 months, 6 months, 9 months, 12 months | |
| Beck Anxiety Inventory | Baseline, 3 months, 6 months, 9 months, 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth E. Freedland, Ph.D. | Washington University School of Medicine Behavioral Medicine Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine Behavioral Medicine Center | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31083052 | Derived | Smagula SF, Freedland KE, Steinmeyer BC, Wallace MJ, Carney RM, Rich MW. Moderators of Response to Cognitive Behavior Therapy for Major Depression in Patients With Heart Failure. Psychosom Med. 2019 Jul/Aug;81(6):506-512. doi: 10.1097/PSY.0000000000000712. | |
| 31045419 | Derived | Freedland KE, Steinmeyer BC, Carney RM, Rubin EH, Rich MW. Use of the PROMIS(R) Depression scale and the Beck Depression Inventory in patients with heart failure. Health Psychol. 2019 May;38(5):369-375. doi: 10.1037/hea0000682. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Heart Failure Self-care Education | Other | Participants in both arms will receive heart failure educational material from the Heart Failure Society of America. In addition, a RN will review educational material with participants during baseline visit and with 3 weekly follow up phone calls. |
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| Medical outcomes study SF-12 |
| Baseline, 3 months, 6 months, 9 months, 12 months |
| PROMIS Physical Functioning Scale | Baseline, 6 months |
| Kansas City Cardiomyopathy Questionnaires | Baseline, 3 months, 6 months, 9 months, 12 months |
| 6 Minute Walk Test | Baseline, 6 months |
| Depression Interview and Structured Hamilton (DISH) | Baseline, 6 months |
| 26414759 | Derived | Freedland KE, Carney RM, Rich MW, Steinmeyer BC, Rubin EH. Cognitive Behavior Therapy for Depression and Self-Care in Heart Failure Patients: A Randomized Clinical Trial. JAMA Intern Med. 2015 Nov;175(11):1773-82. doi: 10.1001/jamainternmed.2015.5220. |