Measurement-Based Care for Bipolar Disorder

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Measurement based care (MBC) is an emerging best practice involving serial assessment of clinical status and using those findings to inform clinical decision making. However, there is a lack of research on how to best apply principles of MBC for patients with bipolar disorder. The proposed project goal is to assess the feasibility of comparing effectiveness of measurement-based care (MBC) to enhanced usual care in a randomized trial. Many individuals with bipolar disorder experience fluctuating depressive and manic symptoms which can impair functioning and reduce quality of life. The main hypothesis is that treatment adjustments will occur more often in the MBC group than the enhanced usual care group. The exploratory hypothesis is that symptoms of bipolar disorder will decrease more in the MBC group than the enhanced usual care group.

Research Team

Joseph Cerimele, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+