Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06671158
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change
Sponsor:
Carilion Clinic
Organization:
Study Overview
Official Title:
An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBC
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: