NCT02266134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable depression

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

October 12, 2014

Results QC Date

February 7, 2022

Last Update Submit

May 4, 2023

Conditions

Keywords

implementationmeasurement based carestandardizedtailored

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Standardized Implementation, Patients

EXPERIMENTAL

Sites in standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).

Behavioral: Standard Implementation of Measurement Based Care

Tailored Implementation, Patients

EXPERIMENTAL

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

Standardized Implementation, Therapists

EXPERIMENTAL

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

Tailored Implementation, Therapists

EXPERIMENTAL

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

Interventions

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.

Tailored Implementation, PatientsTailored Implementation, Therapists

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.

Standardized Implementation, PatientsStandardized Implementation, Therapists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centerstone Connersville

Connersville, Indiana, 47331, United States

Location

Centerstone Martinsville

Martinsville, Indiana, 46151, United States

Location

Centerstone Columbia

Columbia, Tennessee, 38401, United States

Location

Centerstone Dede Wallace Campus

Nashville, Tennessee, 37204, United States

Location

Centerstone Frank Luton Center

Nashville, Tennessee, 37217, United States

Location

Centerstone Tullahoma

Tullahoma, Tennessee, 37388, United States

Location

Related Publications (4)

  • Snider MDH, Boyd MR, Walker MR, Powell BJ, Lewis CC. Using audit and feedback to guide tailored implementations of measurement-based care in community mental health: a multiple case study. Implement Sci Commun. 2023 Aug 14;4(1):94. doi: 10.1186/s43058-023-00474-8.

  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Cara C. Lewis
Organization
Kaiser Permanente Washington Health Research Institute

Study Officials

  • Cara C Lewis, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Investigator

Study Record Dates

First Submitted

October 12, 2014

First Posted

October 16, 2014

Study Start

June 1, 2015

Primary Completion

October 18, 2019

Study Completion

November 15, 2019

Last Updated

June 2, 2023

Results First Posted

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations