NCT06671158 Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change
| NCT ID | NCT06671158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carilion Clinic |
| Condition | Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-10-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Virginia O'Brien, MD
PRINCIPAL INVESTIGATOR
Carilion Clinic
Frequently Asked Questions
Who can join the NCT06671158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671158 currently recruiting?
Yes, NCT06671158 is actively recruiting participants. Contact the research team at askablinger@carilionclinic.org for enrollment information.
Where is the NCT06671158 trial being conducted?
This trial is being conducted at Roanoke, United States.
Who is sponsoring the NCT06671158 clinical trial?
NCT06671158 is sponsored by Carilion Clinic. The principal investigator is Virginia O'Brien, MD at Carilion Clinic. The trial plans to enroll 90 participants.