Measurement-Based Care for Bipolar Disorder

No longer recruiting at 1 trial location

Overseen By Joseph Cerimele, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Inability to consent, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how regular mental health check-ins can improve treatment for people with bipolar disorder. Participants will receive either measurement-based care (MBC), involving frequent assessments of both depressive and manic symptoms, or assessments of only depressive symptoms, compared to usual care. The goal is to determine if this approach leads to better treatment adjustments and fewer symptoms. The trial seeks individuals diagnosed with bipolar disorder who have fluctuating symptoms and are receiving care at a primary care clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health care for others.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems that participants may continue their current treatment, especially since the trial involves ongoing care in the same clinic.

What prior data suggests that this method is safe for patients with bipolar disorder?

Research has shown that measurement-based care (MBC) is generally well-received. This method uses regular check-ups to guide treatment decisions, often improving the quality of care. A review of studies highlights that both doctors and patients find MBC beneficial, with few downsides noted. Importantly, MBC helps identify issues early, which can lower the risk of medication side effects and improve results. Significant problems directly caused by MBC itself have not been reported. This suggests that this treatment method is safe for managing symptoms of bipolar disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using measurement-based care (MBC) for bipolar disorder because it offers a more personalized approach than traditional treatments. Standard treatments often involve fixed medication schedules without frequent adjustments, but MBC continuously assesses a patient's symptoms, allowing for real-time modifications in their care plan. This method empowers patients by actively involving them in their treatment decisions, potentially leading to better outcomes. Additionally, MBC's emphasis on consistent monitoring can help detect mood changes early, potentially preventing severe episodes.

What evidence suggests that measurement-based care is effective for bipolar disorder?

Research shows that measurement-based care (MBC) can effectively treat mood disorders such as depression and bipolar disorder. Studies on depression have found that MBC enables faster recovery and higher rates of symptom relief compared to regular care. This trial will compare two approaches: one arm will receive MBC for both manic and depressive symptoms, while the other will focus on MBC for depressive symptoms only. Although less data exists for bipolar disorder, tracking and responding to symptoms may also benefit individuals with this condition, as bipolar disorder involves mood changes that require careful monitoring and management. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph Cerimele, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for individuals with bipolar disorder who show elevated symptoms, are receiving care in the same primary care clinic, have a clinician's diagnosis of bipolar disorder, and are either newly referred to mental health clinicians or have recently changed their medication. It's not for those unable to consent to research or not planning on returning for follow-up.

Inclusion Criteria

I have been diagnosed with bipolar disorder and am currently experiencing severe symptoms.

I've recently seen a mental health professional or changed my bipolar disorder medication.

I have been diagnosed with bipolar disorder by a doctor.

Exclusion Criteria

I do not plan to return to the same primary care clinic for follow-up.

I am unable to give consent for research participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments conducted pre-randomization to collect socio-demographics and prior treatment history

1 week

1 visit (in-person or online)

Treatment

Participants receive measurement-based care (MBC) or enhanced usual care for depressive and manic symptoms

6 months

Regular clinic visits for assessments

Follow-up

Participants are monitored for treatment changes and symptom severity using various instruments

6 months

Online assessments

What Are the Treatments Tested in This Trial?

Interventions

• Measurement based care

Trial Overview The study is testing if measurement-based care (MBC), which involves regular assessments to guide treatment decisions, is more effective than enhanced usual care at managing bipolar disorder. Participants will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: MBC for depressive and manic symptoms Experimental Treatment 1 Intervention

Measurement-based care (MBC) is a clinical strategy involving consistent assessment of clinical status and using those findings to drive clinical decision making. MBC involves clinic staff providing the measure to the patient at each visit which the patient completes and returns, staff enters results into the electronic medical record, clinician reviews current results and compares to past results, and discusses with the patient. The experimental condition patients will receive MBC for manic and depressive symptoms.

Group II: MBC for depressive symptoms only Active Control 1 Intervention

The active comparator arm patients will receive MBC for depressive symptoms.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10872806/

Bipolar disorder assessment and monitoring measures in ... Measurement-based care has been part of large treatment trials for years such as in the Systematic Treatment Enhancement Program for Bipolar ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11296504/

Comparison of the Efficacy Between Standard ... A recent meta-analysis indicated that using MBC to treat depression has higher remission rates and better medication adherence than usual care.

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

The Efficacy of Measurement-Based Care for Depressive ... For patients with depressive disorders treated with pharmacotherapy, MBC showed higher remission rates, reduced depression severity, and ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.201800383

Systematic Review of Symptom Assessment Measures for ... The aim of this study was to synthesize the literature on patient-reported and clinician-observed measures of symptoms of bipolar disorder and the potential ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11176570/

Determinants of remote measurement‐based care uptake ... This study uses electronic health record data to study variation in completion rates at the clinic and patient level of a remote MBC symptom measure tool.

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

Considerations for Implementation of Measurement-Based ... Measurement-based care (MBC) is the structured process of repeatedly assessing patient-reported outcomes, including recovery, quality of ...

9. medrxiv.org medrxiv.org/content/10.1101/2025.04.13.25323641v1.full.pdf

A Systematic Review of Measurement-Based Care in ... Objective: This systematic review synthesizes clinician and patient perspectives on the benefits and drawbacks of measurement-based care (MBC) ...

10. mmhpi.org mmhpi.org/wp-content/uploads/2024/04/Increasing-Measurement-Based-Assessment-and-Care-for-People-with-Serious-Mental-Illness.pdf

Increasing Measurement-Based Assessment and Care for ... Measurement-based care (MBC) is an important strategy to facilitate early screening, early intervention, mitigation of medication adverse effects and improved ...