Psychotherapy for Depression and Anxiety Disorders

(MBC Trial)

Overseen By Anita Kablinger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Acute psychosis, Intellectual disability, Neurocognitive disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of measurement-based care—a structured method using patient feedback to guide therapy—in treating depression and anxiety compared to usual care or being on a waitlist. Participants will attend 12 weekly therapy sessions. The goal is to determine if this approach improves the management of depressive or anxiety-related symptoms. Individuals who frequently experience depression or anxiety and seek therapy for these reasons might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mental health care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychotherapy, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.

What prior data suggests that measurement-based care is safe for adult behavioral health?

Research has shown that measurement-based care (MBC) is generally safe for treating depression and anxiety. This method involves regular check-ins to monitor symptoms and guide treatment, helping both doctors and patients understand the treatment's effectiveness over time.

Studies indicate that MBC can effectively reduce depression symptoms and improve overall treatment outcomes. Importantly, no major safety concerns have been reported with using MBC. Since this method focuses on tracking and adjusting care based on patient feedback, most patients find it easy to tolerate.

MBC is not a new drug or an invasive procedure, so it lacks the side effects that medications might have. Instead, it enhances regular therapy by making it more personalized and responsive to the patient's needs. Therefore, MBC is a safe option for those considering joining a trial aimed at improving mental health care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Measurement-Based Care (MBC) is unique because it uses regular, systematic assessments to tailor psychotherapy specifically to each individual's progress and needs. Unlike traditional therapy approaches for depression and anxiety, which often rely on less structured feedback, MBC integrates ongoing, real-time data to adjust treatment dynamically. This personalized approach aims to enhance treatment effectiveness and efficiency, making it particularly promising for individuals who may not benefit from standard therapy methods alone. Researchers are excited about MBC because it brings a data-driven, individualized method that could potentially improve outcomes for patients more rapidly compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for depression and anxiety disorders?

Research has shown that measurement-based care (MBC), which participants in this trial may receive, can effectively treat depression and anxiety. Studies indicate that MBC can lead to faster improvement and higher recovery rates compared to regular care. Specifically, patients receiving MBC have demonstrated up to 75% better recovery rates. MBC involves regularly monitoring symptom progression, allowing for more tailored treatments. By systematically evaluating symptoms, MBC enables doctors and patients to track progress and make informed treatment decisions. This approach has transformed behavioral health care delivery, making it a promising option for managing depression and anxiety. ^{1 2 3 6 7}

Who Is on the Research Team?

Virginia O'Brien, MD

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for adults with Generalized Anxiety Disorder or Depression who are seeking treatment. Participants should be willing to attend weekly therapy sessions for three months and can't already be receiving measurement-based care.

Inclusion Criteria

I am seeking therapy for depression or anxiety with specific test scores.

Exclusion Criteria

Significant suicidal/homicidal risk that would need immediate intervention

Currently receiving psychotherapy through another source

I cannot complete health surveys on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly individual psychotherapy sessions for 12 sessions in total

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Measurement-Based Care

Trial Overview The study tests the effectiveness of Measurement-Based Care (MBC) in treating anxiety and depression compared to usual care. It involves a randomized control trial where participants receive either MBC, standard treatment, or are placed on a waitlist.

How Is the Trial Designed?

Group I: Measurement-based care group Experimental Treatment 1 Intervention

Measurement-based care group

Group II: Treatment-as-Usual group Active Control 1 Intervention

Treatment-as-Usual group

Group III: Waitlist control group Active Control 1 Intervention

Waitlist control group

Measurement-Based Care is already approved in United States, European Union for the following indications:

Approved in United States as Measurement-Based Care for:

• Adult Behavioral Health
• Mental Health Conditions

Approved in European Union as Measurement-Based Care for:

• Behavioral Health
• Mental Health Disorders

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

Recent advancements in measurement techniques can enhance evidence-based practices in psychotherapy, ensuring that treatments are effective and tailored to individual needs.

These measurement improvements also facilitate 'practice-based evidence', allowing clinicians to refine their methods and improve outcomes through ongoing evaluation and feedback in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement and psychotherapy. Evidence-based practice and practice-based evidence. Margison, FR., Barkham, M., Evans, C., et al.[2019]

Using outcome measures in psychotherapy can significantly improve treatment results, especially for patients who are likely to struggle with negative outcomes.

A meta-analysis indicates that monitoring patient feedback and providing clinicians with decision-making tools can enhance treatment effectiveness for those showing early signs of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for practice. Whipple, JL., Lambert, MJ.[2015]

Measurement-based care (MBC) is an evidence-based approach that uses client data to guide treatment, leading to improved outcomes and reduced symptom deterioration across various clinical settings.

MBC not only assesses symptoms like depression and anxiety but also evaluates functioning, life satisfaction, and treatment processes, making it a versatile framework for enhancing therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Measurement-Based Care to Enhance Any Treatment. Scott, K., Lewis, CC.[2020]

In a study involving 30 therapists working with adolescents experiencing anxiety and depression, it was found that therapists shared measurement-based care (MBC) data with youth in about 34.6% of sessions and with caregivers in 27.4% of sessions.

Therapists primarily used MBC data to inform short-term treatment decisions in 21.1% of sessions, indicating a need for better training and monitoring to enhance the use of MBC for long-term treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing measurement-based care implementation using therapist report. Casline, E., Woodard, G., Patel, ZS., et al.[2023]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

In clinical trials, 30% of patients do not respond to psychotherapy, and up to 65% leave treatment without any benefit, highlighting the need for better monitoring of patient progress.

Using computer-assisted feedback methods can significantly improve treatment outcomes, reducing deterioration rates in at-risk patients from 21% to 13% and increasing recovery rates from 20% to 35%, with even better results when combined with problem-solving strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing Psychotherapy Outcome beyond Evidence-Based Medicine. Lambert, MJ.[2017]

Fidelity measurement in psychotherapy is evolving beyond just checking treatment efficacy to also assess how well interventions are delivered in real-world settings, which is important for consumers and payers.

Developing a single, effective, and efficient fidelity measurement tool poses challenges, but efforts are being made to create instruments that can evaluate fidelity across different practice contexts and their impact on client outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's a Bird, It's A Plane, It's … Fidelity Measurement In the Real World. Schoenwald, SK.[2021]

Tailored implementation of measurement-based care (MBC) led to a significant increase in the completion rates of the PHQ-9 depression assessment tool over a 5-month period, suggesting that personalized support can enhance clinician engagement.

Despite improvements in PHQ-9 completion, neither the tailored nor standardized MBC implementation significantly impacted depression severity outcomes, indicating that further strategic support may be necessary to optimize treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Versus Tailored Implementation of Measurement-Based Care for Depression in Community Mental Health Clinics. Lewis, CC., Marti, CN., Scott, K., et al.[2023]

A study involving 2233 patients and 79 therapists across eight NHS Trusts found that using an outcome feedback system in psychological therapy significantly reduced symptom severity in patients at risk of poor treatment response, compared to standard treatment.

Patients receiving therapy with outcome feedback showed greater improvements in depression and anxiety scores, indicating that this low-cost technology can enhance the effectiveness of psychological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback-informed treatment versus usual psychological treatment for depression and anxiety: a multisite, open-label, cluster randomised controlled trial. Delgadillo, J., de Jong, K., Lucock, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6584602/

Implementing Measurement-Based Care in Behavioral Health Measurement-based care (MBC) is the systematic evaluation of patient symptoms before or during an encounter to inform behavioral health treatment.

2. apaservices.org apaservices.org/practice/measurement-based-care

Measurement-based care - APA Services Measurement-based care (MBC) describes the evidence-based practice of using systematic and routine assessment of the patient's perspective.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838317

Measurement-Based Care to Enhance Antidepressant ... Conclusions and Relevance This trial of adults with MDD found that MBC led to faster time to response and time to remission than standard care ...

4. apa.org apa.org/monitor/2025/01/measurement-based-care-transforms-treatment

Measurement-based care: A transformative approach to ... MBC is “a clinical process that uses quantitative data to allow clinicians and patients to track patient progress,” explained Jessica Barber, ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.20240372

Considerations for Implementation of Measurement-Based ... Patients receiving MBC have up to 75% greater remission rates compared with those receiving psychiatric treatment without routine symptom ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11609122/

Implementation of Measurement-Based Care in Mental Health ... Measurement-Based Care (MBC) is the systematic use of patient-reported data to inform care decisions and monitor treatment progress.

7. psychiatrist.com psychiatrist.com/jcp/measurement-based-care-depression/

The Efficacy of Measurement-Based Care for Depressive ... MBC is effective in decreasing depression severity, promoting remission, and improving medication adherence in patients with depressive disorders treated with ...