DepressionWBCBHPNCT04321876
Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care
An observational study of Depression, run by Northwestern University at 1 site in United States.
Trial summary
This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Collaborative Behavioral Health Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 778 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult patients attending primary care appointments within the Northwestern Medicine health system's central region.
Who may be able to join
- PHQ-9 score > 10
Who cannot join
- Current suicidality
- Bipolar disorder
- Substance abuse disorder
- Psychosis
- Other severe mental health condition
Trial locations and contacts
1 site in 1 country.
About this study
This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.
Read the detailed description
This study used a hybrid Type 2 effectiveness-implementation design of a randomized roll-out trial of the Collaborative Care Model for depression (CoCM) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. Implementation strategies including hiring and training the necessary staff for CoCM, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. Using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of CBHP roll-out, focused on barriers and facilitators of implementation and sustainability. The Stages of Implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. Effectiveness of CBHP for patient-level outcomes will be conducted on depressive symptoms, graduation rates for CBHP, and spillover effects on chronic health conditions.
With its focus on implementation processes and strategies, this study will elucidate the critical drivers of CoCM implementation that are understudied for a program with such a robust evidence base. This study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for CoCM and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. Changes to the protocol and current status of the study are also discussed.
- Conditions
- Depression
- Being tested
- Collaborative Behavioral Health Program
- Keywords
- primary care, collaborative care model, implementation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Behavioral Health ProgramBehavioural
Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| NMG IM 211 E Chicago Ave | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM ARKES | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 1460 N Halsted St | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 201 E Huron St | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG Integrative Medicine 150 E Huron St | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 1776 N Milwaukee Ave | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 20 S Clark St | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM FM 1704 Maple Ave | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 259 E Erie St | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 1135 S Delano Ct | Not described Receives: Behavioral: Collaborative Behavioral Health Program | |
| NMG IM 1333 W Belmont Ave | Not described Receives: Behavioral: Collaborative Behavioral Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of implementation strategies on the speed of CBHP implementation (time, in days)
Trends in the rate at which CBHP is implemented over successive practices, as assessed by the Universal Stages of Implementation Completion (USIC)
Measured: 2 years
Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)
Trends in the number of CBHP participants over successive practices, as assessed by CBHP referrals, engagement, and treatment completion derived from the electronic health record
Measured: 2 years
Acceptability of CBHP
Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)
Measured: 2 years
Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)
Pre- and post-treatment self-reported depressive symptoms (PHQ-9 scores), anti-depressant medication prescriptions and adherence, treatment engagement, psychiatry referrals
Measured: 2 years
Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)
Proportion of patients who are eligible for CBHP who receive behavioral health services, including anti-depressant medication prescriptions, CBHP treatment sessions, and/or external referrals for behavioral health (e.g., psychiatry)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Sep 2018
- Primary completion31 Jan 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 778 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Medicine
- Responsible party
- Principal investigator, Allison Carroll, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321876
- Sponsor's protocol ID
- STU00208338
- Acronym
- WBCBHP
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smith JD, Hasan M. Quantitative approaches for the evaluation of implementation research studies. Psychiatry Res. 2020 Jan;283:112521. doi: 10.1016/j.psychres.2019.112521. Epub 2019 Aug 17.
PubMed 31473029Kordon A, Carroll AJ, Fu E, Rosenthal LJ, Rado JT, Jordan N, Brown CH, Smith JD. Multilevel perspectives on the implementation of the collaborative care model for depression and anxiety in primary care. BMC Psychiatry. 2024 Jul 22;24(1):519. doi: 10.1186/s12888-024-05930-w.
PubMed 39039458
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care
- ClinicalTrials.gov ID
- NCT04321876
- Acronym / sponsor ID
- WBCBHP / STU00208338
- Conditions
- Depression
- Keywords
- primary care, collaborative care model, implementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Medicine
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 25 Mar 2020 (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.
This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.
Detailed description
This study used a hybrid Type 2 effectiveness-implementation design of a randomized roll-out trial of the Collaborative Care Model for depression (CoCM) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. Implementation strategies including hiring and training the necessary staff for CoCM, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. Using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of CBHP roll-out, focused on barriers and facilitators of implementation and sustainability. The Stages of Implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. Effectiveness of CBHP for patient-level outcomes will be conducted on depressive symptoms, graduation rates for CBHP, and spillover effects on chronic health conditions.
With its focus on implementation processes and strategies, this study will elucidate the critical drivers of CoCM implementation that are understudied for a program with such a robust evidence base. This study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for CoCM and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. Changes to the protocol and current status of the study are also discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| NMG IM 211 E Chicago Ave | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM ARKES | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 1460 N Halsted St | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 201 E Huron St | – | Behavioral: Collaborative Behavioral Health Program |
| NMG Integrative Medicine 150 E Huron St | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 1776 N Milwaukee Ave | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 20 S Clark St | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM FM 1704 Maple Ave | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 259 E Erie St | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 1135 S Delano Ct | – | Behavioral: Collaborative Behavioral Health Program |
| NMG IM 1333 W Belmont Ave | – | Behavioral: Collaborative Behavioral Health Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending primary care appointments within the Northwestern Medicine health system's central region.
Key inclusion criteria (1 listed)
- PHQ-9 score > 10
Key exclusion criteria (5 listed)
- Current suicidality
- Bipolar disorder
- Substance abuse disorder
- Psychosis
- Other severe mental health condition
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 |
|---|---|---|
| Collaborative Behavioral Health ProgramCollaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers. | Behavioural | NMG IM 1135 S Delano Ct, NMG IM 1333 W Belmont Ave, NMG IM 1460 N Halsted St, NMG IM 1776 N Milwaukee Ave, NMG IM 20 S Clark St, NMG IM 201 E Huron St, NMG IM 211 E Chicago Ave, NMG IM 259 E Erie St, NMG IM ARKES, NMG IM FM 1704 Maple Ave, NMG Integrative Medicine 150 E Huron St |
Primary outcome
Impact of implementation strategies on the speed of CBHP implementation (time, in days)
Time frame: 2 years
Trends in the rate at which CBHP is implemented over successive practices, as assessed by the Universal Stages of Implementation Completion (USIC)
Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)
Time frame: 2 years
Trends in the number of CBHP participants over successive practices, as assessed by CBHP referrals, engagement, and treatment completion derived from the electronic health record
Acceptability of CBHP
Time frame: 2 years
Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)
Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)
Time frame: 2 years
Pre- and post-treatment self-reported depressive symptoms (PHQ-9 scores), anti-depressant medication prescriptions and adherence, treatment engagement, psychiatry referrals
Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)
Time frame: 2 years
Proportion of patients who are eligible for CBHP who receive behavioral health services, including anti-depressant medication prescriptions, CBHP treatment sessions, and/or external referrals for behavioral health (e.g., psychiatry)
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 16 Oct 2026.
- Background: PubMed 31473029Smith JD, Hasan M. Quantitative approaches for the evaluation of implementation research studies. Psychiatry Res. 2020 Jan;283:112521. doi: 10.1016/j.psychres.2019.112521. Epub 2019 Aug 17.
- Derived from this study: PubMed 39039458Kordon A, Carroll AJ, Fu E, Rosenthal LJ, Rado JT, Jordan N, Brown CH, Smith JD. Multilevel perspectives on the implementation of the collaborative care model for depression and anxiety in primary care. BMC Psychiatry. 2024 Jul 22;24(1):519. doi: 10.1186/s12888-024-05930-w.
- Individual participant dataSharing planned: Undecided
Related trials for Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Northwestern 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 1 inclusion and 5 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 16 Oct 2026. 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?
Impact of implementation strategies on the speed of CBHP implementation (time, in days) (time frame: 2 years). The study lists 5 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 NCT04321876, which also lists 2 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 16 Oct 2026.