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

Carilion Clinic

Status: Enrolling

Conditions: Anxiety Disorders; Depressive Disorder

Treatments: Behavioral: Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06671158

IRB-23-1992

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Measurement-based care group

Experimental group

Description:

Measurement-based care group

Treatment:

Behavioral: Psychotherapy

Treatment-as-Usual group

Active Comparator group

Description:

Treatment-as-Usual group

Treatment:

Behavioral: Psychotherapy

Waitlist control group

No Intervention group

Description:

Waitlist control group