Depression and Self-care in Heart Failure
DASH
Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression
2 other identifiers
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Jan 2010
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 29, 2014
May 1, 2014
3.8 years
December 4, 2009
May 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BDI-II score at 6 months
Baseline, 3 months, 6 months, 9 months , 12 months
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Cognitive Behavior Therapy
ACTIVE COMPARATORUsual Care
OTHERParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine Behavioral Medicine Center
St Louis, Missouri, 63108, United States
Related Publications (3)
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.
PMID: 31083052DERIVEDFreedland 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.
PMID: 31045419DERIVEDFreedland 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.
PMID: 26414759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth E. Freedland, Ph.D.
Washington University School of Medicine Behavioral Medicine Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2009
First Posted
December 9, 2009
Study Start
January 1, 2010
Primary Completion
October 1, 2013
Study Completion
April 1, 2014
Last Updated
May 29, 2014
Record last verified: 2014-05