Bipolar Disorder Measures in Clinical Care

• ClinicalTrials.gov Identifier: NCT05300919
• Recruitment Status: Not yet recruiting
• First Posted: March 29, 2022
• Last Update Posted: May 4, 2022
• Sponsor: University of Washington
• Collaborators: Mayo Clinic; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Joseph Cerimele, University of Washington

Tracking Information

• First Submitted Date: March 9, 2022
• First Posted Date: March 29, 2022
• Last Update Posted Date: May 4, 2022
• Estimated Study Start Date: June 2023
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 17, 2022)

Treatment changes [ Time Frame: 6 months ]

Medication or psychosocial change in treatment plan.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 17, 2022)

• Additional instrument 1 [ Time Frame: 6 months ]
  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
• Additional instrument 2 [ Time Frame: 6 months ]
  Patient Health Questionnaire-9 (PHQ-9) Minimum value: 0 Maximum value: 27 Higher scores indicates greater severity depressive symptoms
• Additional instrument 3 [ Time Frame: 6 months ]
  Generalized Anxiety Disorder-7 (GAD-7) Minimum value: 0 Maximum value: 21 Higher scores indicates greater severity anxiety symptoms
• Additional instrument 4 [ Time Frame: 6 months ]
  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
• Additional instrument 5 [ Time Frame: 6 months ]
  Drug Abuse Screening Test (DAST-10) Minimum value: 0 Maximum value: 10 Higher scores indicates increased degree of problems related to drug use

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 17, 2022)

Exploratory [ Time Frame: 6 months ]

Exploratory analysis will evaluate the probability of being in remission as defined by euthymic classification on the ISS.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Bipolar Disorder Measures in Clinical Care
• Official Title: Bipolar Disorder Measures in Clinical Care
• 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.

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two-arm parallel assignment.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Bipolar Disorder

Intervention

Other: Measurement based care

Measurement-based care based on arm.

Study Arms

• Experimental: MBC for depressive and manic symptoms

  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.

  Intervention: Other: Measurement based care
• Active Comparator: MBC for depressive symptoms only
  The active comparator arm patients will receive MBC for depressive symptoms.
  Intervention: Other: Measurement based care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 17, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2025
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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,

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Joseph Cerimele, MD; 2062211244; cerimele@uw.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05300919
• Other Study ID Numbers: STUDY00014960; 1R34MH125935-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Starting in July 2025.
• Access Criteria: Following the NIMH Data Archive Guidelines.

• Current Responsible Party: Joseph Cerimele, University of Washington
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Washington
• Original Study Sponsor: Same as current

Collaborators

• Mayo Clinic
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Joseph Cerimele, MD; University of Washington

• PRS Account: University of Washington
• Verification Date: April 2022