Depression and Self-care in Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression

Conditions
-----------------
Heart Failure, Depression

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Therapy
* Other: Heart Failure Self-care Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavior Therapy<br> | Behavioral: Cognitive Behavior Therapy<br>* 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.<br>* Other names: CBT;Other: Heart Failure Self-care Education<br>* 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.<br>* Other names: HFE;|
| Other: Usual Care<br>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. | Other: Heart Failure Self-care Education<br>* 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.<br>* Other names: HFE;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI-II score at 6 months |  | Baseline, 3 months, 6 months, 9 months , 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Depression, Self Care, Cognitive behavior therapy