Evaluating the effectiveness of measurement-based care for depression and anxiety
An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders
This study is testing whether a new approach called measurement-based care can help adults with depression and anxiety feel better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT06671158 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the implementation and effectiveness of measurement-based care (MBC) in adult behavioral health, specifically for individuals with depressive and anxiety disorders. Participants will be randomly assigned to one of three groups: those receiving MBC combined with psychotherapy, those receiving standard treatment, and a waitlist control group. The study will utilize a pragmatic randomized control trial design within the RE-AIM framework to assess outcomes and mechanisms of change associated with MBC. The goal is to determine the added value of MBC compared to usual care and to understand how it influences treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are seeking psychotherapy for depressive or anxiety-related symptoms.
Not a fit: Patients with severe psychiatric conditions, significant suicidal risk, or those currently receiving psychotherapy elsewhere may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment outcomes for patients with depression and anxiety by demonstrating the effectiveness of measurement-based care.
How similar studies have performed: Previous studies have shown positive outcomes with measurement-based care approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roanoke, Virginia
- Carilion Mental Health — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Virginia O'Brien, MD — Carilion Clinic
- Study coordinator: Anita Kablinger, MD
- Email: askablinger@carilionclinic.org
- Phone: 540-527-4875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.