# Bipolar disorder measures in clinical care

> **NIH NIH R34** · UNIVERSITY OF WASHINGTON · 2022 · $249,213

## Abstract

The proposed project goal is to determine which validated bipolar disorder instrument is most
acceptable and helpful to patients and clinicians in clinical care, demonstrate that the preferred
instrument can be used to monitor outcomes with high fidelity in routine care, and assess the feasibility
of comparing effectiveness of measurement-based care (MBC) to 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. Measurement based care (MBC) is an emerging best
practice involving serial assessment of clinical status and using those findings to inform clinical decision
making. When implemented with fidelity, MBC helps clinicians adjust treatment to “treat to target”.
However, no studies have determined preferred bipolar disorder measures for use in clinical care.
Furthermore, adoption of MBC for individuals with bipolar disorder has had especially low uptake in
routine care. The lack of consensus about which measure to use in serial assessment of bipolar
disorder clinical status is likely due to the difficulty of assessing clinical status for patients with bipolar
disorder. There are multiple ways to measure clinical status including measuring functioning or
symptoms, and when measuring symptoms, there is a need to measure changes in both depressive
and manic symptoms. Specifically, there may be uncertainty about how to interpret symptom scale
results with respect to weighing the importance of depression and manic symptom severity (particularly
when they vary in opposite directions between time points). There is a need to determine the optimal
measure for use in MBC for individuals with bipolar disorder. Aims of this R34 include: 1) Using
qualitative methods, obtain input from people with bipolar disorder to choose the preferred instrument
for monitoring bipolar disorder clinical status that is acceptable, helpful, and understandable in
informing when to change treatment. In Aim 1 we expect to identify an Identify an MBC instrument that
is perceived to be acceptable, helpful, and understandable to patients diagnosed with bipolar disorder.
Next, in Aim 2) In a single arm open trial, assess the feasibility of MBC with the preferred instrument for
bipolar disorder and assess fidelity to the protocol including instrument administration, scoring, and
reviewing results. In Aim 2 we expect to achieve high fidelity to the MBC protocol. In Aim 3) Conduct a
randomized pragmatic pilot effectiveness trial comparing the MBC with the preferred instrument for
bipolar disorder to usual care. We will test the Aim 3 hypothesis that treatment adjustments will occur
more often in the MBC group than the usual care group, and the exploratory hypothesis that symptoms
of bipolar disorder will decrease more in the MBC group than the usual care group. These findings will
support an R01 application to conduct a definitive randomized trial.

## Key facts

- **NIH application ID:** 10426702
- **Project number:** 1R34MH125935-01A1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Joseph M. Cerimele
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $249,213
- **Award type:** 1
- **Project period:** 2022-03-18 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10426702

## Citation

> US National Institutes of Health, RePORTER application 10426702, Bipolar disorder measures in clinical care (1R34MH125935-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10426702. Licensed CC0.

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