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Bipolar Disorder Measures in Clinical Care

Primary Purpose

Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measurement based care
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring primary care, measurement-based care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MBC for depressive and manic symptoms

MBC for depressive symptoms only

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Treatment changes
Medication or psychosocial change in treatment plan.

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2022
Last Updated
April 28, 2022
Sponsor
University of Washington
Collaborators
Mayo Clinic, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05300919
Brief Title
Bipolar Disorder Measures in Clinical Care
Official Title
Bipolar Disorder Measures in Clinical Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Mayo Clinic, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
primary care, measurement-based care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm parallel assignment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBC for depressive and manic symptoms
Arm Type
Experimental
Arm Description
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.
Arm Title
MBC for depressive symptoms only
Arm Type
Active Comparator
Arm Description
The active comparator arm patients will receive MBC for depressive symptoms.
Intervention Type
Other
Intervention Name(s)
Measurement based care
Intervention Description
Measurement-based care based on arm.
Primary Outcome Measure Information:
Title
Treatment changes
Description
Medication or psychosocial change in treatment plan.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Additional instrument 1
Description
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
Time Frame
6 months
Title
Additional instrument 2
Description
Patient Health Questionnaire-9 (PHQ-9) Minimum value: 0 Maximum value: 27 Higher scores indicates greater severity depressive symptoms
Time Frame
6 months
Title
Additional instrument 3
Description
Generalized Anxiety Disorder-7 (GAD-7) Minimum value: 0 Maximum value: 21 Higher scores indicates greater severity anxiety symptoms
Time Frame
6 months
Title
Additional instrument 4
Description
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
Time Frame
6 months
Title
Additional instrument 5
Description
Drug Abuse Screening Test (DAST-10) Minimum value: 0 Maximum value: 10 Higher scores indicates increased degree of problems related to drug use
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Exploratory
Description
Exploratory analysis will evaluate the probability of being in remission as defined by euthymic classification on the ISS.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Cerimele, MD
Phone
2062211244
Email
cerimele@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Cerimele, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Starting in July 2025.
IPD Sharing Access Criteria
Following the NIMH Data Archive Guidelines.

Learn more about this trial

Bipolar Disorder Measures in Clinical Care

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