Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change (MBC)

An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders

Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care.

Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework.

Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Anxiety Disorders
• Intervention / Treatment: Behavioral: Psychotherapy

Detailed Description

Measurement-based care (MBC) is an evidenced-based practice, involving routine completion of patient-reported outcome measures and collaborative discussions between clinician and client to inform clinical decision-making and facilitate improvement. Despite its known benefits, such as reduced dropout rates and improved treatment outcomes, questions remain regarding MBC's unique effectiveness compared to standard care. Furthermore, mechanisms of change on how MBC actually works in treatment have yet to be fully investigated. Thus, the current study aims to conduct a randomized control trial to evaluate the added value of MBC, by comparing an MBC+psychotherapy group, a psychotherapy-only group, and a waitlist group with no interventions.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anita Kablinger, MD; Phone Number: 540-527-4875; Email: askablinger@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24018
      • Recruiting
      • Carilion Mental Health
      • Contact: Virginia O'Brien, MD; Phone Number: 540-529-9603; Email: vcobrien@carilionclinic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Primary concern and referral reason for seeking psychotherapy are either depressive- or anxiety-related symptoms and/or psychological distress, using minimum scores as follows: PHQ-9 (score > 4), GAD-7 (score > 4), and BASE-6 (score > 18), and
2. being 18 years old or older.

Exclusion Criteria:

1. Severe physical or psychiatric conditions that would hinder the treatment (e.g., clients with acute psychosis, intellectual disability, or neurocognitive disorders who do not have the capacity to undergo informed consent and participate in the study);
2. currently receiving psychotherapy through another source;
3. significant suicidal/homicidal risk that would need immediate intervention;
4. do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measurement-based care group	Behavioral: Psychotherapy; Individual psychotherapy for weekly 12-sessions
Active Comparator: Treatment-as-Usual group	Behavioral: Psychotherapy; Individual psychotherapy for weekly 12-sessions
No Intervention: Waitlist control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Adjustment Scale-6 (BASE-6)	Self-report questionnaire designed to measure general psychological adjustment and functioning of adult-aged individuals Minimum score: 6 Maximum score: 42 A higher score indicates severe difficulty in psychological adaptation and functioning/worse outcome	Completed weekly through study completion, an average of 3 to 4 months
Patient Health Questionnaire-9 (PHQ-9)	Evaluate depression symptoms Minimum score: 0 Maximum score: 27 A higher score indicates more severe depression/worse outcome	Completed weekly through study completion, an average of 3 to 4 months
Generalized Anxiety Disorder-7 (GAD-7)	evaluate anxiety symptoms Minimum score: 0 Maximum score: 21 A higher score indicates more severe anxiety/worse outcome	Completed weekly through study completion, an average of 3 to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life-Brief (WHOQOL-BREF)	This is a self-report measure designed to assess an individual's quality of life and well-being across four domains, including physical health, psychological well-being, social relationships, and environmental conditions Minimum score: 0 Maximum score: 100 A higher score indicates a higher quality of life/better outcome	Pre-post, through study completion, an average of 3 to 4 months
Working Alliance Inventory-Short Form Revised (WAI-SR)	The WAI-SR is a self-report measure of the strengths of the therapeutic alliance that clients perceive. Minimum score: 12 Maximum score: 60 A higher score indicates a stronger working alliance between the provider and the patient / better outcome	Completed monthly, through study completion, an average of 3 to 4 months
Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)	The VPPS-P is a patient-report measure consisting of 42 items with five subscales, including therapist exploration, negative relationship, patient psychic distress, patient participation, therapist warmth and friendliness, and patient dependency. Minimum score: 42 Maximum score: 210 A higher score indicates better outcome	Completed every 6 weeks; through study completion, an average of 3 to 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impressions - Severity of Illness (CGI-S)	Clinical impressions of the clinician's view on the client's global functioning, the overall severity of symptoms (CGI-S) Minimum score: 1 Maximum score: 7 A higher score indicates more severe impairment/worse outcome	Pre-post, through study completion, an average of 3 to 4 months
Patient's Global Impressions of Severity (PGI-S)	As CGI-S, the PGI-S is a 1-item global impression questionnaires that allow patients to report their own views on the severity of ongoing symptoms based on a 7-point scale Minimum score: 1 Maximum score: 7 A higher score indicates more severe impairment/worse outcome	Pre-post, through study completion, an average of 3 to 4 months
Clinical Global Impressions - Improvement (CGI-I)	Clinical impressions of the client's improvement level that the client shows throughout the therapy (CGI-I) Minimum score: 1 Maximum score: 7 A lower score indicates better outcome	Through study completion, an average of 3 to 4 months
Patient Global Impressions - Improvement (PGI-I)	PGI-S is a 1-item global impression questionnaires that allow patients to report their own views on the response and improvement to intervention based on a 7-point scale Minimum score: 1 Maximum score: 7 A lower score indicates better outcome	Through study completion, an average of 3 to 4 months
Patient Attitudes with and Satisfaction towards Measurement-Based Care (PAS-MBC)	A 12-item tailored questionnaire was created to fully capture clients' attitudes towards and experience with measurement-based care during their treatment. Minimum value: 12 Maximum value: 60 Higher score indicates better outcome/more positive attitudes toward measurement-based care	Through study completion, an average of 3 to 4 months

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Virginia O'Brien, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: effectiveness; RCT; psychotherapy; implementation; measurement-based care; mechanisms of change
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Anxiety Disorders; Depressive Disorder
• Other Study ID Numbers: IRB-23-1992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Due to the need to protect patient confidentiality and privacy regarding identifiable health data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No