Depressive SymptomsNCT03882411
An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)
A study testing Electronic shared decision making (eSDM) tool in people with Depressive Symptoms and Coronary Heart Disease, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depressive Symptoms, Coronary Heart Disease
- What is being tested?
- Electronic shared decision making (eSDM) tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 10 Apr 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of coronary heart disease
- English or Spanish Speaking
- Elevated Depressive symptoms (PHQ9 ≥10)
- Appointment at participating cardiology or primary care clinics
Who cannot join
- Under the care of a psychiatrist [On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period]
- Diagnosis/history of psychosis or schizophrenia
- Diagnosis/history of bipolar disorder
- Attempted suicide
- Non-English or Spanish speaking
- Dementia or severe cognitive impairment
Show all 9Show fewer
- Non-elevated depressive symptoms
- Alcohol or substance abuse
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
About this study
Official title: An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]
The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.
Read the detailed description
Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.
The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a pre-post design across socioeconomically diverse cardiology and primary care clinics.
- Conditions
- Depressive Symptoms, Coronary Heart Disease
- Being tested
- Electronic shared decision making (eSDM) tool
- Keywords
- Implementation science
- Medical subject headings
- Depression, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic shared decision making (eSDM) toolBehavioural
Also called eSDM intervention
The web application includes depression screening, behavioral activation, and a patient preference driven treatment selection decision aid. Treatment options will include medications, cardiac rehab/exercise program, and therapy. In addition to education, providers will receive a patient preference report in real time with options for coordination of care
| Study group | Role | What they receive |
|---|---|---|
| Electronic shared decision making (eSDM) Tool | Experimental | In the pre-intervention period, patients in clinic clusters will receive usual care.
When a clinic cluster's randomly allotted intervention period arrives, coronary heart disease patients in that given clinic cluster will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive education and a patient preference report generated from the application.
During both the pre and post intervention periods, patients will be assessed at baseline and 6 month follow up. Receives: Behavioral: Electronic shared decision making (eSDM) tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Index (BDI-II)
Change in total BDI (21-item measure of depressive symptoms [0-63]; higher score constitutes worse burden of symptoms) from baseline to follow visit during the pre-intervention period compared to post-intervention period
Measured: Baseline, Follow-up visit (approximately 6 months)
Secondary outcomes (4)
Proportion of patients who initiate treatment
Proportion of enrolled patients who initiate any depression treatment (medications, cardiac rehab/exercise program, therapy) from baseline to follow up visit in the pre-intervention compared to post-intervention period
Measured: Baseline, Follow-up visit (approximately 6 months)
Mean Patient Activation
Mean baseline patient activation measure [PAM] (13-items, range 0-100, higher score indicates greater activation] in the pre-intervention compared to post-intervention period
Measured: Baseline
Mean Decisional Conflict Scale
Mean decisional conflict (measures personal perceptions of uncertainty around choosing among treatment option, 10 items, range 0-100, higher score indicates greater conflict) of patients.
Measured: Baseline
Mean change in quality of life (QoL)
Change in QoL from from baseline to follow up visit in the pre-intervention compared to post-intervention period
Measured: Baseline, Follow-up visit (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start23 Apr 2019
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post single group design with 8 clinic clusters randomized to timing of receipt of intervention with patients nested within providers nested within clinic clusters.
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nathalie Moise, Columbia University
- Investigators
- Nathalie Moise, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882411
- Sponsor's protocol ID
- AAAR9175 - III
- Other IDs
- 1R01HL141609-01
- Status last verified
- Jun 2025
- First submitted
- 15 Mar 2019
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]
- ClinicalTrials.gov ID
- NCT03882411
- Acronym / sponsor ID
- AAAR9175 - III
- Conditions
- Depressive Symptoms, Coronary Heart Disease
- Keywords
- Implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 20 Mar 2019 (actual)
- 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 this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.
Detailed description
Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.
The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a pre-post design across socioeconomically diverse cardiology and primary care clinics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post single group design with 8 clinic clusters randomized to timing of receipt of intervention with patients nested within providers nested within clinic clusters.
| Arm | Type | Receives |
|---|---|---|
| Electronic shared decision making (eSDM) Tool | Experimental | Behavioral: Electronic shared decision making (eSDM) toolIn the pre-intervention period, patients in clinic clusters will receive usual care. When a clinic cluster's randomly allotted intervention period arrives, coronary heart disease patients in that given clinic cluster will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive education and a patient preference report generated from the application. During both the pre and post intervention periods, patients will be assessed at baseline and 6 month follow up. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of coronary heart disease
- English or Spanish Speaking
- Elevated Depressive symptoms (PHQ9 ≥10)
- Appointment at participating cardiology or primary care clinics
Key exclusion criteria (9 listed)
- Under the care of a psychiatrist [On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period]
- Diagnosis/history of psychosis or schizophrenia
- Diagnosis/history of bipolar disorder
- Attempted suicide
- Non-English or Spanish speaking
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 |
|---|---|---|
| Electronic shared decision making (eSDM) toolAlso: eSDM interventionThe web application includes depression screening, behavioral activation, and a patient preference driven treatment selection decision aid. Treatment options will include medications, cardiac rehab/exercise program, and therapy. In addition to education, providers will receive a patient preference report in real time with options for coordination of care | Behavioural | Electronic shared decision making (eSDM) Tool |
Primary outcome
Beck Depression Index (BDI-II)
Time frame: Baseline, Follow-up visit (approximately 6 months)
Change in total BDI (21-item measure of depressive symptoms [0-63]; higher score constitutes worse burden of symptoms) from baseline to follow visit during the pre-intervention period compared to post-intervention period
4 secondary outcomes
Proportion of patients who initiate treatment
Time frame: Baseline, Follow-up visit (approximately 6 months)
Mean Patient Activation
Time frame: Baseline
Mean Decisional Conflict Scale
Time frame: Baseline
Mean change in quality of life (QoL)
Time frame: Baseline, Follow-up visit (approximately 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 13 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Nathalie Moise, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic shared decision making (eSDM) tool in people with Depressive Symptoms and Coronary Heart Disease, run by Columbia University 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 4 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 13 Jun 2025. 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?
Beck Depression Index (BDI-II) (time frame: Baseline, Follow-up visit (approximately 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.