Bipolar Disorder Measures in Clinical Care
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ClinicalTrials.gov Identifier: NCT05300919 |
Recruitment Status :
Not yet recruiting
First Posted : March 29, 2022
Last Update Posted : May 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder | Other: Measurement based care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Two-arm parallel assignment. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Bipolar Disorder Measures in Clinical Care |
Estimated Study Start Date : | June 2023 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
---|---|
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. |
Other: Measurement based care
Measurement-based care based on arm. |
Active Comparator: MBC for depressive symptoms only
The active comparator arm patients will receive MBC for depressive symptoms.
|
Other: Measurement based care
Measurement-based care based on arm. |
- Treatment changes [ Time Frame: 6 months ]Medication or psychosocial change in treatment plan.
- 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
- Exploratory [ Time Frame: 6 months ]Exploratory analysis will evaluate the probability of being in remission as defined by euthymic classification on the ISS.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05300919
Contact: Joseph Cerimele, MD | 2062211244 | cerimele@uw.edu |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Joseph Cerimele, MD | University of Washington |
Responsible Party: | Joseph Cerimele, Assistant professor, School of Medicine: Psychiatry, University of Washington |
ClinicalTrials.gov Identifier: | NCT05300919 |
Other Study ID Numbers: |
STUDY00014960 1R34MH125935-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | March 29, 2022 Key Record Dates |
Last Update Posted: | May 4, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
primary care measurement-based care |
Bipolar Disorder Bipolar and Related Disorders Mood Disorders Mental Disorders |