Standardized Versus Tailored Implementation of Measurement Based Care for Depression (iMBC)

Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion annually; however, Measurement Based Care (MBC) is a relatively simple evidence-based intervention framework that has been shown to improve outcomes for depressed clients by identifying those who are not making progress and reducing the likelihood that clients will deteriorate in treatment. Despite the demonstrated effectiveness of MBC, the majority of community mental health counselors do not regularly assess target problem symptoms to guide their work. This study will test a standardized versus a tailored approach to implementing MBC that will include the integration of symptom monitoring capacities into the electronic health record system of one of the nation's largest not-for-profit providers of behavioral health services.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Standard Implementation of Measurement Based Care; Behavioral: Tailored Implementation of Measurement Based Care

Detailed Description

Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion annually. Depression has been called the "Common Cold" of mental illness, but one with serious risk of morbidity and mortality. There are now many evidence-based practices for the treatment of depression, but unfortunately these practices remain largely unavailable to clients receiving services in community mental health centers. Measurement Based Care (MBC) is a relatively simple evidence-based intervention framework. MBC, by definition, is the practice of using symptom measurement to inform mental health care. Physicians who routinely measure the patient's blood pressure when the treatment target is high blood pressure demonstrate the medical corollary of MBC. When MBC is used in the treatment of depressed adults, it has been shown to improve outcomes by identifying clients who are not making progress and reducing the likelihood that clients will deteriorate in treatment. However, despite the demonstrated effectiveness of MBC, the majority of community mental health counselors (i.e., clinicians) do not regularly assess target problem symptoms to guide their work over the course of treatment. To our knowledge, no studies to date have focused on the process of implementing MBC in community mental health settings. The long-term goal of this research project is to provide generalizable and practical recommendations about implementation approaches that promote MBC use and fidelity in community mental health centers. Specifically, this study will test a standardized versus a tailored approach to implementing MBC in one of the nation's largest not-for-profit providers of behavioral health services. Although touted as superior, tailored implementations have rarely been compared to standardized approaches. Moreover, recent research has demonstrated an apparent need to adapt evidence-based practices to fit the specific context in which they are being implemented, particularly if they are to be sustained. This proposal reflects a movement in the field of implementation science in which planned adaptations are being tested and compared to standardized versions. The proposed research is a three-phase, mixed methods (quantitative/qualitative) study to investigate the effect of these two different approaches to MBC implementation on both clinician-level (e.g., MBC fidelity) and client-level (depression symptom change) outcomes. We will focus on contextual factors (e.g., attitudes, resources, process, etc.) that may influence the implementation process with the goal of identifying a generalizable and practical way of bringing MBC to community mental health centers treating depressed adults.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Connersville, Indiana, United States, 47331
      • Centerstone Connersville
    • Martinsville, Indiana, United States, 46151
      • Centerstone Martinsville
  • Tennessee
    • Columbia, Tennessee, United States, 38401
      • Centerstone Columbia
    • Nashville, Tennessee, United States, 37204
      • Centerstone Dede Wallace Campus
    • Nashville, Tennessee, United States, 37217
      • Centerstone Frank Luton Center
    • Tullahoma, Tennessee, United States, 37388
      • Centerstone Tullahoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

To be included, Patients must:

1. be age 18 or above at time of enrollment;
2. have depression as one of their primary treatment foci based on diagnosis made by clinicians using usual care interview methods to reflect major depressive disorder, dysthymic disorder, depressive disorder NOS, adjustment disorder with depressed mood;
3. have significant depressive symptom severity (PHQ-9 total score > 9);
4. receive individual psychotherapy;
5. be fluent in English; and
6. receive therapy from an enrolled study clinician during the proposed funding period

Patients will be excluded if they have an inability to sign the consent form (due to lack of competence or inability to read).

Therapist Inclusion Criteria -- Therapists must:

1. be a practicing clinician at Centerstone; and
2. see at least one adult (18+) patient

Therapist Exclusion Criteria: N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized Implementation, Patients; Sites in standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).	Behavioral: Standard Implementation of Measurement Based Care; Measurement-based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire (PHQ-9); the implementation of measurement-based care will be standardized such that clinicians will be encouraged to administer the PHQ-9 to depressed clients before each session.
Experimental: Tailored Implementation, Patients; Sites in the tailored condition arm will receive the tailored implementation of measurement-based care intervention (PHQ-9).	Behavioral: Tailored Implementation of Measurement Based Care; Measurement-based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire; the implementation of measurement-based care will be tailored based on clinic specific barriers and facilitators.
Experimental: Standardized Implementation, Therapists; Sites randomized to the standardized condition will be expected to use the measurement-based care intervention (PHQ-9) prior to each session with a depressed client and they will work as a team to maximize fidelity.	Behavioral: Standard Implementation of Measurement Based Care; Measurement-based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire (PHQ-9); the implementation of measurement-based care will be standardized such that clinicians will be encouraged to administer the PHQ-9 to depressed clients before each session.
Experimental: Tailored Implementation, Therapists; Sites randomized to the tailored condition will develop a site-specific protocol for use of the measurement-based care intervention (PHQ-9), and they will work as a team to maximize the fit of measurement-based care to this clinic.	Behavioral: Tailored Implementation of Measurement Based Care; Measurement-based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire; the implementation of measurement-based care will be tailored based on clinic specific barriers and facilitators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire	Patient Health Questionnaire-9 (PHQ-9): screening tool for depression that can be used to monitor symptom change over time and inform care. Minimum value: 0 Maximum value: 27 Higher scores indicate a greater severity of depression (i.e., worse outcome).	Week 0 (baseline) and Week 12 of treatment
PHQ-9 Completed Fidelity	PHQ-9 fidelity was monitored for each individual psychotherapy session. Fidelity was scored as: (1) Therapist did not complete or record any PHQ-9 scores; (2) Therapist completed PHQ-9 and recorded scores in the EHR only; or (3) Therapist completed PHQ-9, recorded scores in the EHR, and discussed scores with the patient. The unit of measure is the number individual psychotherapy sessions conducted during the 5-month implementation window. Patient data were included for any patient at least 18 years old at the time of their first session with a participating therapist, regardless of if the patient was enrolled in the study.	5-month implementation window

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Cara C Lewis, PhD, Indiana University

Publications and helpful links

General Publications

• Lewis CC, Boyd MR, Marti CN, Albright K. Mediators of measurement-based care implementation in community mental health settings: results from a mixed-methods evaluation. Implement Sci. 2022 Oct 21;17(1):71. doi: 10.1186/s13012-022-01244-1.
• Albright K, Navarro EI, Jarad I, Boyd MR, Powell BJ, Lewis CC. Communication strategies to facilitate the implementation of new clinical practices: a qualitative study of community mental health therapists. Transl Behav Med. 2022 Feb 16;12(2):324-334. doi: 10.1093/tbm/ibab139.
• Lewis CC, Scott K, Marti CN, Marriott BR, Kroenke K, Putz JW, Mendel P, Rutkowski D. Implementing measurement-based care (iMBC) for depression in community mental health: a dynamic cluster randomized trial study protocol. Implement Sci. 2015 Sep 7;10:127. doi: 10.1186/s13012-015-0313-2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: October 12, 2014
• First Submitted That Met QC Criteria: October 12, 2014
• First Posted (Estimated): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: implementation; tailored; measurement based care; standardized
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 1R01MH103310-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO