Depressive SymptomsDepCareNCT05085886
Implementation Science Approach to Enhancing Depression Treatment in Collaborative Depression Care Settings ( DepCare )
A study testing DepCare in people with Depressive Symptoms, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of a multi-level intervention - centered around a web-application that facilitates depression screening, automated shared decision making (SDM), patient activation, and psychoeducation - on mental health treatment optimization among patients with elevated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- DepCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish Speaking
- ≥ 18 years of age
- Elevated depressive symptoms Elevated Patient Health Questionnaire (PHQ)-9 >=10 Elevated PHQ-9 >=5 and Generalized Anxiety Disorder (GAD)-7 >= 10
Who cannot join
- Under the care of a psychiatrist or depression collaborative care manager in the prior 3 months
- Diagnosis of psychosis or schizophrenia
- Diagnosis of bipolar disorder
- Dementia or severe cognitive impairment
- History of coronary heart disease
- Pregnancy
- Dementia or severe cognitive impairment
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: A Randomized Control Trial of a Multi-level Theoretical Approach to Enhancing Patient Engagement in Primary Care Settings Sustaining Collaborative Depression Care (Transform DepCare)
The purpose of this study is to examine the effectiveness of a multi-level intervention - centered around a web-application that facilitates depression screening, automated shared decision making (SDM), patient activation, and psychoeducation - on mental health treatment optimization among patients with elevated depressive symptoms with or without co-morbid anxiety receiving care in primary care clinics that offer collaborative care. The objectives of the study include: Leveraging user centered design to refine a strategy centered around an electronic SDM (eSDM) tool (aim 1), and assessing the effect of the strategy on provider behavior (aim 2) and on patient enrollment in depression treatment (aim 3).
Read the detailed description
Collaborative care, a team-based approach to integrating primary and behavioral health, is effective in reducing depressive and anxiety symptoms and improving clinical outcomes. However, attempts to optimize collaborative care in real world settings have been hindered by patient (stigma, low self-efficacy, low perceived treatment efficacy), provider (suboptimal symptom recognition and communication at referral), and system (limited resources, lack of screening) level barriers. Few if any prior studies have focused on assessing the effectiveness of multi-level strategies to optimize treatment engagement in primary care settings in the sustainability phase of collaborative care.
Using the behavior change wheel (BCW) framework, we created a multi-level strategy for optimizing treatment in primary care settings with collaborative care programs. The strategy involves system/staff-level problem solving, patient-level electronic screening, patient activation, and an automated shared decision-making tool in addition to primary care provider-level behavioral health education with automated decisional support.
The investigators now aim to test this multifaceted implementation strategy for optimizing treatment amongst patients with elevated depressive symptoms (with or without co-morbid anxiety) in the ambulatory care network (ACN) clinics of New York Presbyterian Hospital (NYPH) with established/mature collaborative care programs that predominantly care for socioeconomically disadvantaged and minority patients. We will randomize providers to either the multicomponent strategy or enhanced usual care. The investigators aim to assess the effectiveness of this intervention on patient engagement in mental health treatment (primary outcome) as well as on provider action to optimize/manage treatment (secondary outcome).
- Conditions
- Depressive Symptoms
- Being tested
- DepCare, Enhanced Usual Care
- Keywords
- collaborative care, implementation science, Elevated Depressive Symptoms
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepCareBehavioural
Primary Care Provider (1) One-time presentation or video with education and motivational messaging around collaborative care, functionality of the DepCare patient tool and optimal management of depression and comorbid anxiety (2) Quality improvement/ implementation team meetings on optimizing mental health treatment in primary care and DepCare (i.e., multi-level, multi-component intervention) implementation (3) Automatically-generated decisional support on individual patient treatment preferences (i.e., for every patient who receives the DepCare patient tool) Patient: Tool comprised of enhanced depression and anxiety screening (includes option for voice-over questions, point-and-click responses), and for those who screen positive for depressive symptoms (with or without comorbid anxiety), diagnosis recognition support, psycho-education, videos promoting patient engagement in treatment, and personalized medication selection support.
Enhanced Usual CareBehavioural
Clinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization
| Study group | Role | What they receive |
|---|---|---|
| DepCare Intervention | Experimental | The clinic (administrators, staff, care managers) will receive quality improvement support and education around depression screening as well as local technical assistance for mental health treatment optimization. The cluster of primary care providers in the intervention arm will receive education and decisional support for optimizing mental health treatment and access to quality improvement/implementation meetings. When feasible, eligible patients will receive a tool that facilitates enhanced screening, diagnosis recognition, treatment selection support, psychoeducation, and activation. Receives: Behavioral: DepCare; Behavioral: Enhanced Usual Care |
| Enhanced Usual Care | Active comparator | The clinic (administrators, staff, care managers) will receive quality improvement support and education around depression screening as well as local technical assistance for mental health treatment optimization. The cluster of primary care providers and patients in the active comparator arm will have access to this clinic-level strategy (i.e., the same clinic level intervention as in the DepCare group), but will not receive any provider or patient-level interventions. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total proportion of patients who initiate or optimize depression treatment
The proportion of patients who initiate or optimize depression treatment, defined as those with at least 1 mental health visit or antidepressant fill during the 4 months following enrollment. Hypothesis 1: this proportion will be greater for patients of providers in the DepCare arm than for the Enhanced Usual Care arm
Measured: During 4 months post-index visit
Secondary outcomes (5)
Proportion of patients whose providers take action to optimize depression treatment
The proportion of patients whose providers take action to optimize their patients' depression treatment at the index visit (baseline), defined as placing a mental health referral for collaborative care or other mental health services; initiating, intensifying, switching and/or combining antidepressant medications; and/or providing depression management counseling [i.e., on adherence to treatment regimen]. Hypothesis 2: this proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.
Measured: Baseline
Change in proportion of patients receiving any depression treatment
Change from baseline in the proportion of patients receiving any treatment for depression, defined as filling an antidepressant and/or attending one or more mental health visits during the 4 months following enrollment. Hypothesis 3: This proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.
Measured: 4 months pre-Index Visit, 4 months post-index visit
Proportion of patients with at least 2 mental health visits
The proportion of patients with at least 2 mental health visits (i.e., with a mental health specialist). Hypothesis 4: This proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.
Measured: During 6 months post-index visit
Proportion of patients with at least 2 antidepressant fills
The proportion of patients with at least 2 antidepressant fills. Hypothesis 5: This proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.
Measured: During 6 months post-index visit
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. Hypothesis 5: the mean decisional conflict will be lower for the DepCare arm than for the Enhanced Usual Care arm (in subset consented to receive tool only).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start3 Aug 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm design with provider being the unit of randomization and patients being nested within provider
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Nathalie Moise, Columbia University
- Investigators
- Nathalie Moise, MD, MS, Principal investigator, Florence Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085886
- Sponsor's protocol ID
- AAAT6753
- Other IDs
- R01HS025198
- Acronym
- DepCare
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, we plan to make available a deidentified database that includes PHQ data, patient engagement, optimization, demographics and comorbidity characteristics of patients in our study Study protocol statistical analysis plan Analytic code. Within 1 year of publication of trial primary outcome results
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of a Multi-level Theoretical Approach to Enhancing Patient Engagement in Primary Care Settings Sustaining Collaborative Depression Care (Transform DepCare)
- ClinicalTrials.gov ID
- NCT05085886
- Acronym / sponsor ID
- DepCare / AAAT6753
- Conditions
- Depressive Symptoms
- Keywords
- collaborative care, implementation science, Elevated Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Oct 2021 (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 effectiveness of a multi-level intervention - centered around a web-application that facilitates depression screening, automated shared decision making (SDM), patient activation, and psychoeducation - on mental health treatment optimization among patients with elevated depressive symptoms with or without co-morbid anxiety receiving care in primary care clinics that offer collaborative care. The objectives of the study include: Leveraging user centered design to refine a strategy centered around an electronic SDM (eSDM) tool (aim 1), and assessing the effect of the strategy on provider behavior (aim 2) and on patient enrollment in depression treatment (aim 3).
Detailed description
Collaborative care, a team-based approach to integrating primary and behavioral health, is effective in reducing depressive and anxiety symptoms and improving clinical outcomes. However, attempts to optimize collaborative care in real world settings have been hindered by patient (stigma, low self-efficacy, low perceived treatment efficacy), provider (suboptimal symptom recognition and communication at referral), and system (limited resources, lack of screening) level barriers. Few if any prior studies have focused on assessing the effectiveness of multi-level strategies to optimize treatment engagement in primary care settings in the sustainability phase of collaborative care.
Using the behavior change wheel (BCW) framework, we created a multi-level strategy for optimizing treatment in primary care settings with collaborative care programs. The strategy involves system/staff-level problem solving, patient-level electronic screening, patient activation, and an automated shared decision-making tool in addition to primary care provider-level behavioral health education with automated decisional support.
The investigators now aim to test this multifaceted implementation strategy for optimizing treatment amongst patients with elevated depressive symptoms (with or without co-morbid anxiety) in the ambulatory care network (ACN) clinics of New York Presbyterian Hospital (NYPH) with established/mature collaborative care programs that predominantly care for socioeconomically disadvantaged and minority patients. We will randomize providers to either the multicomponent strategy or enhanced usual care. The investigators aim to assess the effectiveness of this intervention on patient engagement in mental health treatment (primary outcome) as well as on provider action to optimize/manage treatment (secondary outcome).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm design with provider being the unit of randomization and patients being nested within provider
| Arm | Type | Receives |
|---|---|---|
| DepCare Intervention | Experimental | Behavioral: DepCare, Behavioral: Enhanced Usual CareThe clinic (administrators, staff, care managers) will receive quality improvement support and education around depression screening as well as local technical assistance for mental health treatment optimization. The cluster of primary care providers in the intervention arm will receive education and decisional support for optimizing mental health treatment and access to quality improvement/implementation meetings. When feasible, eligible patients will receive a tool that facilitates enhanced screening, diagnosis recognition, treatment selection support, psychoeducation, and activation. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareThe clinic (administrators, staff, care managers) will receive quality improvement support and education around depression screening as well as local technical assistance for mental health treatment optimization. The cluster of primary care providers and patients in the active comparator arm will have access to this clinic-level strategy (i.e., the same clinic level intervention as in the DepCare group), but will not receive any provider or patient-level interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English or Spanish Speaking
- ≥ 18 years of age
- Elevated depressive symptoms Elevated Patient Health Questionnaire (PHQ)-9 >=10 Elevated PHQ-9 >=5 and Generalized Anxiety Disorder (GAD)-7 >= 10
Key exclusion criteria (7 listed)
- Under the care of a psychiatrist or depression collaborative care manager in the prior 3 months
- Diagnosis of psychosis or schizophrenia
- Diagnosis of bipolar disorder
- Dementia or severe cognitive impairment
- History of coronary heart disease
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 |
|---|---|---|
| DepCarePrimary Care Provider (1) One-time presentation or video with education and motivational messaging around collaborative care, functionality of the DepCare patient tool and optimal management of depression and comorbid anxiety (2) Quality improvement/ implementation team meetings on optimizing mental health treatment in primary care and DepCare (i.e., multi-level, multi-component intervention) implementation (3) Automatically-generated decisional support on individual patient treatment preferences (i.e., for every patient who receives the DepCare patient tool) Patient: Tool comprised of enhanced depression and anxiety screening (includes option for voice-over questions, point-and-click responses), and for those who screen positive for depressive symptoms (with or without comorbid anxiety), diagnosis recognition support, psycho-education, videos promoting patient engagement in treatment, and personalized medication selection support. | Behavioural | DepCare Intervention |
| Enhanced Usual CareClinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization | Behavioural | DepCare Intervention, Enhanced Usual Care |
Primary outcome
Total proportion of patients who initiate or optimize depression treatment
Time frame: During 4 months post-index visit
The proportion of patients who initiate or optimize depression treatment, defined as those with at least 1 mental health visit or antidepressant fill during the 4 months following enrollment. Hypothesis 1: this proportion will be greater for patients of providers in the DepCare arm than for the Enhanced Usual Care arm
5 secondary outcomes
Proportion of patients whose providers take action to optimize depression treatment
Time frame: Baseline
Change in proportion of patients receiving any depression treatment
Time frame: 4 months pre-Index Visit, 4 months post-index visit
Proportion of patients with at least 2 mental health visits
Time frame: During 6 months post-index visit
Proportion of patients with at least 2 antidepressant fills
Time frame: During 6 months post-index visit
Mean decisional conflict scale
Time frame: Baseline
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 14 Feb 2025.
- Individual participant dataSharing planned: Yes. Upon request, we plan to make available a deidentified database that includes PHQ data, patient engagement, optimization, demographics and comorbidity characteristics of patients in our study Study protocol statistical analysis plan Analytic code. Within 1 year of publication of trial primary outcome results
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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
Florence Assistant Professor 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 DepCare in people with Depressive Symptoms, 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 3 inclusion and 7 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 14 Feb 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?
Total proportion of patients who initiate or optimize depression treatment (time frame: During 4 months post-index visit). 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 14 Feb 2025.