Bipolar DisorderNCT05300919
Bipolar Disorder Measures in Clinical Care
A study testing Measurement based care in people with Bipolar Disorder, run by University of Cincinnati at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Measurement based care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- Inability to consent to participation in research, not planning to return for follow-up in the same primary care clinic
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
About this study
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.
Read the detailed description
Study setting: Five primary care clinics with integrated psychiatric and psychological services.
Study population: Goal recruitment is 30 patients diagnosed with bipolar disorder currently receiving treatment in study sites. Patients will be identified through clinician referrals, chart review, and searching the Epic patient panel functionality of the IBH service.
Study design: This pilot randomized effectiveness trial will assess feasibility (whether the intervention can be practically used in a setting) and acceptability (view that the intervention is agreeable or satisfactory) of the research procedures (e.g., recruitment, enrollment, consent, inclusion/exclusion criteria, randomization, participation, data collection). The investigators will use block randomization at the patient level. Within the five clinics, blocks of 3 will be used to ensure equal numbers of intervention and control patients. This will allow for the 30 patients to be randomly assigned to the 2 arms of the study, with equal numbers within clinics.
The investigators propose an effectiveness trial design with broad inclusion criteria and limited exclusion criteria. The investigators will use intent to treat analyses. To avoid contamination, the research coordinator will administer the measures to patients in both trial arms (enhanced usual care, and MBC with preferred measure) at clinic visits. The intervention patients will receive measures for manic and depressive symptoms, and the control patients will receive a measure of depressive symptoms. Usual care will be enhanced by the research coordinator consistently administering the depressive symptom measure to control arm participants, which is not part of usual care.
Fidelity Measurement: Chart review will be used to assess fidelity in both arms based on whether the patient completed the measure, whether the clinician reviewed measure results, and whether the clinician compared current symptom severity to past symptom severity.
Data collection and management: Individuals approached regarding the study will have an established case record to track eligibility, enrollment, and attrition. REDcap will be the primary data management database. The investigators will also pilot the survey instrument to collect independent measures of clinical outcomes. The dependent variable ISS will also be administered at 6-month follow-up. The ISS is a standard outcome measure in clinical trials, where it was highly sensitive to change. The ISS is excellent for research assessment. The investigators will pilot test other instruments for future use including alcohol use (AUDIT-C), drug use (DAST), posttraumatic stress disorder symptoms (PC-PTSD5), and anxiety symptoms (GAD-7). At baseline, the investigators will also measure socio-demographics and prior treatment history. Outcome assessments will be conducted in person or online at baseline pre-randomization, and online at 6 months to mask assessment. At follow-up, chart review will assess treatment changes, and type and frequency of services received during the 6-months.
Hypotheses: The primary hypothesis is that more treatment changes will occur for patients randomized to MBC with manic and depressive symptom measures compared to enhanced usual care (control condition). Exploratory analysis will evaluate the probability of being in remission as defined by euthymic classification on the ISS. An exploratory hypothesis is that there will be a greater decrease in symptom severity in those randomized to MBC compared to enhanced usual care.
Sample size: The sample size of 30 is sufficient to assess feasibility. There will not be sufficient power for statistical tests unless a large effect size is observed.
Attrition: The investigators will use established practices such as telephone follow-up and financial incentives to maximize retention.
Statistical analyses: Primary data analysis is to assess acceptability and feasibility. The investigators will report eligibility percentages, enrollment rates, attrition rates, proportion of appointments attended, fidelity in both arms, number of treatment changes made per patient, and descriptive statistics and data missingness for patient reported outcomes. The investigators will descriptively summarize these feasibility measures and conduct chi square tests to test baseline differences in rates between the two groups. The investigators will perform intent to treat analyses using a negative binomial regression to model total count of treatment changes in the prior six months specified as the dependent variable and group randomization status as the explanatory variable. To assess successful randomization, the investigators will compare baseline variables for significant differences. If significant differences exist, the investigators will control for those differences in analyses. Because it is pilot study, the investigators have not conducted a power analysis, as the investigators do not expect to have power to detect anything except very large effect sizes.
- Conditions
- Bipolar Disorder
- Being tested
- Measurement based care
- Keywords
- primary care, measurement-based care
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement based careOther
Measurement-based care based on arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Measurement based care |
| MBC for depressive symptoms only | Active comparator | The active comparator arm patients will receive MBC for depressive symptoms. Receives: Other: Measurement based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment changes
Medication or psychosocial change in treatment plan.
Measured: 6 months
Secondary outcomes (4)
Additional instrument 1
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item.
Minimum value: 12 Maximum value: 60 Higher scores indicate higher disability or loss of function
Measured: 6 months
Additional instrument 2
Patient Health Questionnaire-9 (PHQ-9) Minimum value: 0 Maximum value: 27 Higher scores indicates greater severity depressive symptoms
Measured: 6 months
Additional instrument 3
Generalized Anxiety Disorder-7 (GAD-7) Minimum value: 0 Maximum value: 21 Higher scores indicates greater severity anxiety symptoms
Measured: 6 months
Additional instrument 4
The Primary Care Post-traumatic stress disorder screen for DSM5 (PC-PTSD5) Minimum value: 0 Maximum value: 5 Higher scores indicates increased risk PTSD symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joseph Cerimele, University of Cincinnati
- Investigators
- Joseph Cerimele, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300919
- Sponsor's protocol ID
- STUDY00014960
- Other IDs
- 1R34MH125935-01A1
- Status last verified
- Apr 2025
- First submitted
- 9 Mar 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will follow the NIH Data Sharing for Applicants and Awardees information including detailed descriptions the NIH Data Archive. The NIMH advises collection of Common Data Elements some of which we have proposed collecting already (including age, sex at birth, PHQ-9, GAD-7). We will also use the WHODAS 2.0 as a Common Data Element. We intend to share Common Data Elements collected in our study according to the NIMH Data Archive repositories' standard timeline. This timeline includes submission every six months, and the data will be shared after a four-month quality assurance period. We will use Standard Data Dictionaries proposed on the NIMH Data Archive to describe the data set.
Publications
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.
PubMed 37967752
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Disorder Measures in Clinical Care
- ClinicalTrials.gov ID
- NCT05300919
- Acronym / sponsor ID
- STUDY00014960
- Conditions
- Bipolar Disorder
- Keywords
- primary care, measurement-based care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study setting: Five primary care clinics with integrated psychiatric and psychological services.
Study population: Goal recruitment is 30 patients diagnosed with bipolar disorder currently receiving treatment in study sites. Patients will be identified through clinician referrals, chart review, and searching the Epic patient panel functionality of the IBH service.
Study design: This pilot randomized effectiveness trial will assess feasibility (whether the intervention can be practically used in a setting) and acceptability (view that the intervention is agreeable or satisfactory) of the research procedures (e.g., recruitment, enrollment, consent, inclusion/exclusion criteria, randomization, participation, data collection). The investigators will use block randomization at the patient level. Within the five clinics, blocks of 3 will be used to ensure equal numbers of intervention and control patients. This will allow for the 30 patients to be randomly assigned to the 2 arms of the study, with equal numbers within clinics.
The investigators propose an effectiveness trial design with broad inclusion criteria and limited exclusion criteria. The investigators will use intent to treat analyses. To avoid contamination, the research coordinator will administer the measures to patients in both trial arms (enhanced usual care, and MBC with preferred measure) at clinic visits. The intervention patients will receive measures for manic and depressive symptoms, and the control patients will receive a measure of depressive symptoms. Usual care will be enhanced by the research coordinator consistently administering the depressive symptom measure to control arm participants, which is not part of usual care.
Fidelity Measurement: Chart review will be used to assess fidelity in both arms based on whether the patient completed the measure, whether the clinician reviewed measure results, and whether the clinician compared current symptom severity to past symptom severity.
Data collection and management: Individuals approached regarding the study will have an established case record to track eligibility, enrollment, and attrition. REDcap will be the primary data management database. The investigators will also pilot the survey instrument to collect independent measures of clinical outcomes. The dependent variable ISS will also be administered at 6-month follow-up. The ISS is a standard outcome measure in clinical trials, where it was highly sensitive to change. The ISS is excellent for research assessment. The investigators will pilot test other instruments for future use including alcohol use (AUDIT-C), drug use (DAST), posttraumatic stress disorder symptoms (PC-PTSD5), and anxiety symptoms (GAD-7). At baseline, the investigators will also measure socio-demographics and prior treatment history. Outcome assessments will be conducted in person or online at baseline pre-randomization, and online at 6 months to mask assessment. At follow-up, chart review will assess treatment changes, and type and frequency of services received during the 6-months.
Hypotheses: The primary hypothesis is that more treatment changes will occur for patients randomized to MBC with manic and depressive symptom measures compared to enhanced usual care (control condition). Exploratory analysis will evaluate the probability of being in remission as defined by euthymic classification on the ISS. An exploratory hypothesis is that there will be a greater decrease in symptom severity in those randomized to MBC compared to enhanced usual care.
Sample size: The sample size of 30 is sufficient to assess feasibility. There will not be sufficient power for statistical tests unless a large effect size is observed.
Attrition: The investigators will use established practices such as telephone follow-up and financial incentives to maximize retention.
Statistical analyses: Primary data analysis is to assess acceptability and feasibility. The investigators will report eligibility percentages, enrollment rates, attrition rates, proportion of appointments attended, fidelity in both arms, number of treatment changes made per patient, and descriptive statistics and data missingness for patient reported outcomes. The investigators will descriptively summarize these feasibility measures and conduct chi square tests to test baseline differences in rates between the two groups. The investigators will perform intent to treat analyses using a negative binomial regression to model total count of treatment changes in the prior six months specified as the dependent variable and group randomization status as the explanatory variable. To assess successful randomization, the investigators will compare baseline variables for significant differences. If significant differences exist, the investigators will control for those differences in analyses. Because it is pilot study, the investigators have not conducted a power analysis, as the investigators do not expect to have power to detect anything except very large effect sizes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment.
| Arm | Type | Receives |
|---|---|---|
| MBC for depressive and manic symptoms | Experimental | Other: Measurement based careMeasurement-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. |
| MBC for depressive symptoms only | Active comparator | Other: Measurement based careThe active comparator arm patients will receive MBC for depressive symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- Inability to consent to participation in research, not planning to return for follow-up in the same primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement based careMeasurement-based care based on arm. | Other | MBC for depressive and manic symptoms, MBC for depressive symptoms only |
Primary outcome
Treatment changes
Time frame: 6 months
Medication or psychosocial change in treatment plan.
4 secondary outcomes
Additional instrument 1
Time frame: 6 months
Additional instrument 2
Time frame: 6 months
Additional instrument 3
Time frame: 6 months
Additional instrument 4
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 37967752Cerimele 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.
- Individual participant dataSharing planned: Yes. This study will follow the NIH Data Sharing for Applicants and Awardees information including detailed descriptions the NIH Data Archive. The NIMH advises collection of Common Data Elements some of which we have proposed collecting already (including age, sex at birth, PHQ-9, GAD-7). We will also use the WHODAS 2.0 as a Common Data Element. We intend to share Common Data Elements collected in our study according to the NIMH Data Archive repositories' standard timeline. This timeline includes submission every six months, and the data will be shared after a four-month quality assurance period. We will use Standard Data Dictionaries proposed on the NIMH Data Archive to describe the data set.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cerimele, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement based care in people with Bipolar Disorder, run by University of Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment changes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.