Depression, Heart Failure
Conditions
Keywords
Heart failure, Depression, Self Care, Cognitive behavior therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavior Therapy
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.
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New York Heart Association Class I, II, or III Heart Failure (Clinically diagnosed at least 3 months ago) * Meets the DSM-IV criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode. * PHQ-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today
Exclusion criteria
* Less than 30 years old * Current ETOH / drug abuse * Bipolar disorder, schizophrenia, or other psychotic disorder * Communication barrier * Dementia * Currently in competing research protocol * High risk for suicide * Insurmountable logistical barriers to laboratory assessment visits * Major mobility-limiting physical disability * Poor 1 year prognosis not r/t heart failure * Hospitalized for heart failure or acute coronary syndrome in last month * Initiated antidepressant therapy in the past 4 weeks * Current non-study psychotherapy for depression or other psychiatric problem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BDI-II score at 6 months | Baseline, 3 months, 6 months, 9 months , 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Beck Anxiety Inventory | Baseline, 3 months, 6 months, 9 months, 12 months |
| Medical outcomes study SF-12 | Baseline, 3 months, 6 months, 9 months, 12 months |
| PROMIS Physical Functioning Scale | Baseline, 6 months |
| Self-care of Heart Failure Index | 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 |
| Kansas City Cardiomyopathy Questionnaires | Baseline, 3 months, 6 months, 9 months, 12 months |
Countries
United States
Outcome results
None listed