Depression and Self-care in Heart Failure (DASH)
Primary Purpose
Heart Failure, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Heart Failure Self-care Education
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Depression, Self Care, Cognitive behavior therapy
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
Sites / Locations
- Washington University School of Medicine Behavioral Medicine Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Cognitive Behavior Therapy
Usual Care
Arm Description
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.
Outcomes
Primary Outcome Measures
BDI-II score at 6 months
Secondary Outcome Measures
Self-care of Heart Failure Index
Beck Anxiety Inventory
Medical outcomes study SF-12
PROMIS Physical Functioning Scale
Kansas City Cardiomyopathy Questionnaires
6 Minute Walk Test
Depression Interview and Structured Hamilton (DISH)
Full Information
NCT ID
NCT01028625
First Posted
December 4, 2009
Last Updated
May 27, 2014
Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01028625
Brief Title
Depression and Self-care in Heart Failure
Acronym
DASH
Official Title
Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Depression
Keywords
Heart failure, Depression, Self Care, Cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavior Therapy
Arm Type
Active Comparator
Arm Title
Usual Care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Heart Failure Self-care Education
Other Intervention Name(s)
HFE
Intervention Description
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.
Primary Outcome Measure Information:
Title
BDI-II score at 6 months
Time Frame
Baseline, 3 months, 6 months, 9 months , 12 months
Secondary Outcome Measure Information:
Title
Self-care of Heart Failure Index
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Beck Anxiety Inventory
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Medical outcomes study SF-12
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
PROMIS Physical Functioning Scale
Time Frame
Baseline, 6 months
Title
Kansas City Cardiomyopathy Questionnaires
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
6 Minute Walk Test
Time Frame
Baseline, 6 months
Title
Depression Interview and Structured Hamilton (DISH)
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth E. Freedland, Ph.D.
Organizational Affiliation
Washington University School of Medicine Behavioral Medicine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine Behavioral Medicine Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31083052
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. Erratum In: Psychosom Med. 2019 Sep;81(7):674.
Results Reference
derived
PubMed Identifier
31045419
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.
Results Reference
derived
PubMed Identifier
26414759
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.
Results Reference
derived
Learn more about this trial
Depression and Self-care in Heart Failure
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