Clinical trial NCT01028625: Depression and Self-care in Heart Failure
Official title: Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Depression
Keywords: Heart failure
Depression
Self Care
Cognitive behavior therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-12-09
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: BDI-II score at 6 months
timeFrame: Baseline, 3 months, 6 months, 9 months , 12 months
Secondary outcomes:
measure: Self-care of Heart Failure Index
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Beck Anxiety Inventory
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Medical outcomes study SF-12
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: PROMIS Physical Functioning Scale
timeFrame: Baseline, 6 months
measure: Kansas City Cardiomyopathy Questionnaires
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: 6 Minute Walk Test
timeFrame: Baseline, 6 months
measure: Depression Interview and Structured Hamilton (DISH)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine Behavioral Medicine Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine Behavioral Medicine Center
name: Kenneth E. Freedland, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.