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NCT Number: NCT04321876

Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PHQ-9 score > 10

Exclusion criteria

  • Current suicidality
  • Bipolar disorder
  • Substance abuse disorder
  • Psychosis
  • Other severe mental health condition

Treatment and study plan

Collaborative Behavioral Health Program

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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

  3. Acceptability of CBHP

    Time frame: 2 years

    Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Northwestern Medicine

Registry information

Acronym: WBCBHP

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Mar 25, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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