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Measurement-Based Care for Bipolar Disorder

N/A

Waitlist Available

Led By Joseph Cerimele, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elevated symptoms of bipolar disorder based on classification by the Internal State Scale (ISS) as depressed, mixed manic-depressive, or (hypo)manic state

Clinician diagnosis of bipolar disorder

Must not have

Not planning to return for follow-up in the same primary care clinic

Inability to consent to participation in research

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of measurement-based care to enhanced usual care in people with bipolar disorder. 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on measuring clinical status and adjusting treatments accordingly rather than testing new medications, specific side effects aren't listed. However, changes in treatment could potentially lead to typical medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with bipolar disorder by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am unable to give consent for research participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment changes

Secondary study objectives

Additional instrument 1

Additional instrument 2

Additional instrument 3

+2 more

Other study objectives

Exploratory

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MBC for depressive and manic symptomsExperimental Treatment1 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 onlyActive Control1 Intervention

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

0 / 4Eligibility criteria met