Clinical trial NCT06671158: Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change
Official title: An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorders
Keywords: measurement-based care
effectiveness
RCT
implementation
psychotherapy
mechanisms of change
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2024-11-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Adjustment Scale-6 (BASE-6)
timeFrame: Completed weekly through study completion, an average of 3 to 4 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Completed weekly through study completion, an average of 3 to 4 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Completed weekly through study completion, an average of 3 to 4 months
Secondary outcomes:
measure: World Health Organization Quality of Life-Brief (WHOQOL-BREF)
timeFrame: Pre-post, through study completion, an average of 3 to 4 months
measure: Working Alliance Inventory-Short Form Revised (WAI-SR)
timeFrame: Completed monthly, through study completion, an average of 3 to 4 months
measure: Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)
timeFrame: Completed every 6 weeks; through study completion, an average of 3 to 4 months
Other outcomes:
measure: Clinical Global Impressions - Severity of Illness (CGI-S)
timeFrame: Pre-post, through study completion, an average of 3 to 4 months
measure: Patient's Global Impressions of Severity (PGI-S)
timeFrame: Pre-post, through study completion, an average of 3 to 4 months
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: Through study completion, an average of 3 to 4 months
measure: Patient Global Impressions - Improvement (PGI-I)
timeFrame: Through study completion, an average of 3 to 4 months
measure: Patient Attitudes with and Satisfaction towards Measurement-Based Care (PAS-MBC)
timeFrame: Through study completion, an average of 3 to 4 months
Locations:
city: Roanoke
country: United States
facility: Carilion Mental Health
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Virginia O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References: