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Standardized Versus Tailored Implementation of Measurement Based Care for Depression

Standardized Versus Tailored Implementation of Measurement Based Care for Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02266134
Acronym
iMBC
Enrollment
382
Registered
2014-10-16
Start date
2015-06-30
Completion date
2019-11-15
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

implementation, measurement based care, standardized, tailored

Brief summary

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.

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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALTailored 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.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health QuestionnaireWeek 0 (baseline) and Week 12 of treatmentPatient 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).
PHQ-9 Completed Fidelity5-month implementation windowPHQ-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.

Countries

United States

Participant flow

Recruitment details

12 community-based behavioral health clinics were randomized into four groups: (1) Sites 1-2; (2) Sites 3-6; (3) Sites 7-10; and (4) Sites 11-12. Therapist recruitment was in-person or via email from June 3, 2015-October 18, 2016. Patient recruitment was staggered such that each site began recruitment approximately five months apart. Recruitment start dates: (1) Sites 1-2: August 13, 2015; Sites 3-6: December 7, 2015; Sites 7-10: May 20, 2016; and Sites 11-12: December 2, 2016.

Pre-assignment details

Of the 2459 patients assessed for eligibility, 228 met inclusion criteria and were enrolled during the study's active implementation window (0-5 months). Of the 525 therapists assessed for eligibility, 154 met inclusion criteria and consented during the study's active implementation window (0-5 months).

Participants by arm

ArmCount
Standardized Implementation, Patients
Sites in this arm will receive the standard implementation of measurement based care intervention. 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.
141
Tailored Implementation, Patients
Sites in this arm will receive the tailored implementation of measurement based care intervention. 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.
87
Standardized Implementation, Therapists
Sites randomized to the standardized condition will be expected to use the Patient Health Questionnaire prior to each session with a depressed client and they will work as a team to maximize fidelity.
71
Tailored Implementation, Therapists
Sites randomized to the tailored condition will develop a site-specific protocol for use of the Patient Health Questionnaire and they will work as a team to maximize the fit of measurement based care to this clinic.
83
Total382

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Clinics #11-12: Beginning Dec 2016Lost to Follow-up6200
Clinics #11-12: Beginning Dec 2016Withdrawal by Subject3000
Clinics #1-2: Beginning Aug 2015Lost to Follow-up6300
Clinics #3-6: Beginning Dec 2015Lost to Follow-up8200
Clinics #7-10: Beginning May 2016Lost to Follow-up10500
Clinics #7-10: Beginning May 2016Withdrawal by Subject3000

Baseline characteristics

CharacteristicTotalStandardized Implementation, PatientsTailored Implementation, PatientsStandardized Implementation, TherapistsTailored Implementation, Therapists
Age, Continuous41.32 years
STANDARD_DEVIATION 12.36
42.06 years
STANDARD_DEVIATION 11.48
40.14 years
STANDARD_DEVIATION 11.74
45.23 years
STANDARD_DEVIATION 14.07
41.99 years
STANDARD_DEVIATION 13.22
Ethnicity (NIH/OMB)
Hispanic or Latino
31 Participants13 Participants15 Participants3 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
347 Participants127 Participants70 Participants67 Participants83 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants1 Participants2 Participants1 Participants0 Participants
Highest Education Status
Associate's degree
14 Participants9 Participants5 Participants0 Participants0 Participants
Highest Education Status
Bachelor's degree
16 Participants8 Participants4 Participants2 Participants2 Participants
Highest Education Status
Doctoral degree or equivalent
5 Participants2 Participants0 Participants2 Participants1 Participants
Highest Education Status
High school diploma or equivalent
84 Participants54 Participants30 Participants0 Participants0 Participants
Highest Education Status
Master's degree
148 Participants2 Participants1 Participants66 Participants79 Participants
Highest Education Status
Missing or not reported
1 Participants0 Participants0 Participants0 Participants1 Participants
Highest Education Status
Other
11 Participants6 Participants4 Participants1 Participants0 Participants
Highest Education Status
Some college, but no degree
69 Participants34 Participants35 Participants0 Participants0 Participants
Highest Education Status
Some high school
34 Participants26 Participants8 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
6 Participants1 Participants3 Participants2 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
46 Participants22 Participants6 Participants10 Participants8 Participants
Race (NIH/OMB)
More than one race
6 Participants2 Participants1 Participants2 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
24 Participants11 Participants12 Participants1 Participants0 Participants
Race (NIH/OMB)
White
299 Participants105 Participants65 Participants55 Participants74 Participants
Region of Enrollment
United States
382 participants141 participants87 participants71 participants83 participants
Sex/Gender, Customized
Gender Identity
Female
278 Participants96 Participants61 Participants54 Participants67 Participants
Sex/Gender, Customized
Gender Identity
Male
102 Participants44 Participants26 Participants17 Participants15 Participants
Sex/Gender, Customized
Gender Identity
Missing
1 Participants1 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Gender Identity
Non-binary
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Gender Identity
Transgender
1 Participants0 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1411 / 87
other
Total, other adverse events
0 / 1411 / 87
serious
Total, serious adverse events
5 / 1418 / 87

Outcome results

Primary

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).

Time frame: Week 0 (baseline) and Week 12 of treatment

Population: In the standardized implementation condition, 141 patients provided baseline data and 102/141 participants provided 12-week data. In the tailored implementation condition, 87 patients provided baseline data and 74/87 provided 12-week data.

ArmMeasureGroupValue (MEAN)Dispersion
Standardized ImplementationPatient Health QuestionnaireBaseline18.04 score on a scaleStandard Deviation 4.1
Standardized ImplementationPatient Health Questionnaire12-Week12.15 score on a scaleStandard Deviation 6.07
Tailored ImplementationPatient Health QuestionnaireBaseline16.77 score on a scaleStandard Deviation 4.73
Tailored ImplementationPatient Health Questionnaire12-Week13.09 score on a scaleStandard Deviation 5.76
Primary

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.

Time frame: 5-month implementation window

Population: For each participating therapist, the raw counts of fidelity (scored as 1, 2, or 3) are included at the session-level for the 15,686 individual psychotherapy sessions.

ArmMeasureGroupValue (COUNT_OF_UNITS)
Standardized ImplementationPHQ-9 Completed Fidelity1. PHQ-9 Not Completed4894 Individual psychotherapy sessions
Standardized ImplementationPHQ-9 Completed Fidelity2. PHQ-9 Completed (Reported in EHR) Only1564 Individual psychotherapy sessions
Standardized ImplementationPHQ-9 Completed Fidelity3. PHQ-9 Completed and Discussed with Patient1112 Individual psychotherapy sessions
Tailored ImplementationPHQ-9 Completed Fidelity1. PHQ-9 Not Completed5270 Individual psychotherapy sessions
Tailored ImplementationPHQ-9 Completed Fidelity2. PHQ-9 Completed (Reported in EHR) Only860 Individual psychotherapy sessions
Tailored ImplementationPHQ-9 Completed Fidelity3. PHQ-9 Completed and Discussed with Patient1986 Individual psychotherapy sessions

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026