Heart FailureDASH-2NCT02997865
Stepped Care for Depression in Heart Failure
A study testing Stepped care for depression in people with Heart Failure and Depressive Disorder, Major, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Heart Failure, Depressive Disorder, Major
- What is being tested?
- Stepped care for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
- Current major depressive episode.
- Baseline Beck Depression Inventory (BDI-II) score 14 or greater
Who cannot join
- Dementia or other significant cognitive or communication deficits
- Terminal illness other than HF
- Insurmountable logistical barriers to participation
- Age less than 25 years
- Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
- High risk of suicide
Show all 9Show fewer
- Current participation in non-study psychotherapy for depression or other psychiatric conditions
- Initiation or modification of antidepressant medication treatment within past two months
- Renal or hepatic conditions that would preclude the use of antidepressants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Medicine Center Washington University
St Louis, Missouri, 63108
About this study
This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.
Read the detailed description
Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure.
Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications.
Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.
- Conditions
- Heart Failure, Depressive Disorder, Major
- Being tested
- Stepped care for depression
- Keywords
- heart failure, depressive disorder, major, cognitive therapy, self-care
- Medical subject headings
- Heart Failure, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped care for depressionBehavioural
Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care for Depression | Experimental | Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support. Receives: Behavioral: Stepped care for depression |
| Enhanced Usual Care | No intervention | Participants will receive individually-tailored heart failure self-care education and support. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI-2) Total Score
The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.
Measured: 16 weeks
Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.
Measured: 16 weeks
Secondary outcomes (4)
Beck Anxiety Inventory
The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety.
Measured: 16 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status.
Measured: 16 weeks
Hamilton Rating Scale for Depression (HAM-D-17)
The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and >17 moderate to severe depression.
Measured: 16 weeks
Actigraphy
Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start17 Feb 2017
- Primary completion31 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Outcomes assessor
- Enrolment
- 139 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, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997865
- Sponsor's protocol ID
- R01HL131524
- Other IDs
- R01HL131524
- Acronym
- DASH-2
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2016
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may share de-identified data with other researchers after the completion of the study; no specific plans for this have been made yet.
Publications
Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rubin EH, Rich MW. Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial. Circ Heart Fail. 2022 Aug;15(8):e009422. doi: 10.1161/CIRCHEARTFAILURE.121.009422. Epub 2022 Jun 21.
PubMed 35973032Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rich MW. Outcomes of a tailored self-care intervention for patients with heart failure and major depression: A secondary analysis of a randomized controlled trial. Int J Nurs Stud. 2023 Nov;147:104585. doi: 10.1016/j.ijnurstu.2023.104585. Epub 2023 Aug 9.
PubMed 37611354Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rich MW. Treatment of depression and inadequate self-care in patients with heart failure: One-year outcomes of a randomized controlled trial. Gen Hosp Psychiatry. 2023 Sep-Oct;84:82-88. doi: 10.1016/j.genhosppsych.2023.06.001. Epub 2023 Jun 7.
PubMed 37406374
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Depression in Heart Failure
- ClinicalTrials.gov ID
- NCT02997865
- Acronym / sponsor ID
- DASH-2 / R01HL131524
- Conditions
- Heart Failure, Depressive Disorder, Major
- Keywords
- heart failure, depressive disorder, major, cognitive therapy, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.
Detailed description
Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure.
Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications.
Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care for Depression | Experimental | Behavioral: Stepped care for depressionParticipants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support. |
| Enhanced Usual Care | No intervention | –Participants will receive individually-tailored heart failure self-care education and support. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
- Current major depressive episode.
- Baseline Beck Depression Inventory (BDI-II) score 14 or greater
Key exclusion criteria (9 listed)
- Dementia or other significant cognitive or communication deficits
- Terminal illness other than HF
- Insurmountable logistical barriers to participation
- Age less than 25 years
- Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
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 |
|---|---|---|
| Stepped care for depressionCognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated. | Behavioural | Stepped Care for Depression |
Primary outcome
Beck Depression Inventory (BDI-2) Total Score
Time frame: 16 weeks
The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.
Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
Time frame: 16 weeks
The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.
4 secondary outcomes
Beck Anxiety Inventory
Time frame: 16 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 16 weeks
Hamilton Rating Scale for Depression (HAM-D-17)
Time frame: 16 weeks
Actigraphy
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35973032Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rubin EH, Rich MW. Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial. Circ Heart Fail. 2022 Aug;15(8):e009422. doi: 10.1161/CIRCHEARTFAILURE.121.009422. Epub 2022 Jun 21.
- Derived from this study: PubMed 37611354Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rich MW. Outcomes of a tailored self-care intervention for patients with heart failure and major depression: A secondary analysis of a randomized controlled trial. Int J Nurs Stud. 2023 Nov;147:104585. doi: 10.1016/j.ijnurstu.2023.104585. Epub 2023 Aug 9.
- Derived from this study: PubMed 37406374Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rich MW. Treatment of depression and inadequate self-care in patients with heart failure: One-year outcomes of a randomized controlled trial. Gen Hosp Psychiatry. 2023 Sep-Oct;84:82-88. doi: 10.1016/j.genhosppsych.2023.06.001. Epub 2023 Jun 7.
- Individual participant dataSharing planned: Yes. We may share de-identified data with other researchers after the completion of the study; no specific plans for this have been made yet.
Related trials for Heart Failure
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Supporting Health in Veterans With Heart Failure
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Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped care for depression in people with Heart Failure and Depressive Disorder, Major, 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 9 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 10 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Beck Depression Inventory (BDI-2) Total Score (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 NCT02997865, 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 10 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.