Bipolar Disorder Measures in Clinical Care

NCT05300919 | Completed DMC

• 2 other identifiers: STUDY000149601R34MH125935-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

primary care; measurement-based care

Outcome Measures

Primary Outcomes (1)

• Treatment changes

  Medication or psychosocial change in treatment plan.

  6 months

Secondary Outcomes (4)

• Additional instrument 1

  6 months

• Additional instrument 2

  6 months

• Additional instrument 3

  6 months

• Additional instrument 4

  6 months

Study Arms (2)

MBC for depressive and manic symptoms

EXPERIMENTAL

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.

Other: Measurement based care

MBC for depressive symptoms only

ACTIVE COMPARATOR

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

Other: Measurement based care

Interventions

Measurement based care OTHER

Measurement-based care based on arm.

MBC for depressive and manic symptoms; MBC for depressive symptoms only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinician diagnosis of bipolar disorder, and elevated symptoms of bipolar disorder based on classification by the Internal State Scale (ISS) as depressed, mixed manic-depressive, or (hypo)manic state, planned continued care in the same primary care clinic, and either a new consultation by or referral to the integrated behavioral health (IBH) mental health clinicians, or a recent change in bipolar disorder medication treatment,

You may not qualify if:

• Inability to consent to participation in research, not planning to return for follow-up in the same primary care clinic

Sponsors & Collaborators

• University of Cincinnati: lead
• Mayo Clinic: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Cerimele JM, Franta G, Blanchard BE, Leasure W, Fortney JC. Bipolar Disorder Symptom Monitoring Measures: A Mixed-Methods Study of Patient Preferences. J Acad Consult Liaison Psychiatry. 2024 Mar-Apr;65(2):148-156. doi: 10.1016/j.jaclp.2023.11.266. Epub 2023 Nov 14.

  PMID: 37967752 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Joseph Cerimele, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Medicine: Psychiatry

Model Details: Two-arm parallel assignment.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 29, 2022
• Study Start: November 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Starting in July 2025.
• Access Criteria: Following the NIMH Data Archive Guidelines.

Locations

US (2)