Heart FailureDASHNCT01028625
Depression and Self-care in Heart Failure
A study testing Cognitive Behavior Therapy and Heart Failure Self-care Education in people with Heart Failure and Depression, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Heart Failure, Depression
- What is being tested?
- Cognitive Behavior Therapy and Heart Failure Self-care Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 30 years old
- Current ETOH / drug abuse
- Bipolar disorder, schizophrenia, or other psychotic disorder
- Communication barrier
- Dementia
- Currently in competing research protocol
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine Behavioral Medicine Center
St Louis, Missouri, 63108
About this study
Official title: Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression
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.
Read the 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.
- Conditions
- Heart Failure, Depression
- Being tested
- Cognitive Behavior Therapy, Heart Failure Self-care Education
- Keywords
- Heart failure, Depression, Self Care, Cognitive behavior therapy
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called CBT
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.
Heart Failure Self-care EducationOther
Also called HFE
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy | Active comparator | Not described Receives: Behavioral: Cognitive Behavior Therapy; Other: Heart Failure Self-care Education |
| Usual Care | Other | 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. Receives: Other: Heart Failure Self-care Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDI-II score at 6 months
Measured: Baseline, 3 months, 6 months, 9 months , 12 months
Secondary outcomes (7)
Self-care of Heart Failure Index
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Beck Anxiety Inventory
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Medical outcomes study SF-12
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
PROMIS Physical Functioning Scale
Measured: Baseline, 6 months
Kansas City Cardiomyopathy Questionnaires
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
6 Minute Walk Test
Measured: Baseline, 6 months
Depression Interview and Structured Hamilton (DISH)
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kenneth E. Freedland, Ph.D., Principal investigator, Washington University School of Medicine Behavioral Medicine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028625
- Sponsor's protocol ID
- 201013037
- Other IDs
- 1R01HL091918
- Acronym
- DASH
- Status last verified
- May 2014
- First submitted
- 4 Dec 2009
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31083052Freedland 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.
PubMed 31045419Freedland 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.
PubMed 26414759
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression
- ClinicalTrials.gov ID
- NCT01028625
- Acronym / sponsor ID
- DASH / 201013037
- Conditions
- Heart Failure, Depression
- Keywords
- Heart failure, Depression, Self Care, Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy | Active comparator | Behavioral: Cognitive Behavior Therapy, Other: Heart Failure Self-care Education |
| Usual Care | Other | Other: Heart Failure Self-care EducationParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Less than 30 years old
- Current ETOH / drug abuse
- Bipolar disorder, schizophrenia, or other psychotic disorder
- Communication barrier
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior TherapyAlso: CBTCBT 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. | Behavioural | Cognitive Behavior Therapy |
| Heart Failure Self-care EducationAlso: HFEParticipants 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. | Other | Cognitive Behavior Therapy, Usual Care |
Primary outcome
BDI-II score at 6 months
Time frame: Baseline, 3 months, 6 months, 9 months , 12 months
7 secondary outcomes
Self-care of Heart Failure Index
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Beck Anxiety Inventory
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Medical outcomes study SF-12
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
PROMIS Physical Functioning Scale
Time frame: Baseline, 6 months
Kansas City Cardiomyopathy Questionnaires
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
6 Minute Walk Test
Time frame: Baseline, 6 months
Depression Interview and Structured Hamilton (DISH)
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Derived from this study: PubMed 31083052Smagula 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.
- Derived from this study: PubMed 31045419Freedland 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.
- Derived from this study: PubMed 26414759Freedland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth E. Freedland, Ph.D. principal investigator
Washington University School of Medicine Behavioral Medicine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy and Heart Failure Self-care Education in people with Heart Failure and Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDI-II score at 6 months (time frame: Baseline, 3 months, 6 months, 9 months , 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028625, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.