Evidence map›Paper›PMID 41220091›Full record

Trial reportBipolar disorders2025

Association Between Adherence Barriers, Self-Reported Adherence, and Psychiatric Symptoms Among Adults With Bipolar Disorder.

Martha Sajatovic, Jennifer B Levin, Clara Adeniyi, Jessica Black, Celeste Weise, Nicole Fiorelli, Erika Kelley, Doug Einstadter, Mark Bauer, Farren B S Briggs

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Bipolar disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04622150 (Effectiveness RCT of Customized Adherence Enhancement), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04622150 nacompletednot on this map

Effectiveness RCT of Customized Adherence Enhancement

TypeinterventionalSponsorCase Western Reserve UniversityRan2022 to 2026Enrolled190ConditionsBipolar DisorderArmsCustomized Adherence Enhancement (CAE), Enhanced Treatment as Usual (eTAU)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Martha SajatovicDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.ORCID 0000-0002-3073-668X
Jennifer B LevinDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.ORCID 0000-0003-1214-0636
Clara AdeniyiDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Jessica BlackDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Celeste WeiseDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Nicole FiorelliDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Erika KelleyDepartment of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Doug EinstadterCenter for Health Care Research and Policy, MetroHealth System Cleveland, Cleveland, Ohio, USA.
Mark BauerDepartment of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.
Farren B S BriggsDepartment of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.

Funding

Effectiveness RCT of Customized Adherence EnhancementR01MH119487 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI LEVIN, JENNIFER BETH, SAJATOVIC, MARTHA X · 2020 to 2024
$3.6M
NIMH NIH HHS 1R01 MH119487-01A1NIMH NIH HHS R01 MH119487
6 · The paper itself

Abstract

aimsWhile suboptimal medication adherence is a widely recognized problem for people with bipolar disorder (BD), it is less clear how individual characteristics are associated with varying levels of adherence and how specific adherence barriers impact behaviors. This interim analysis from an ongoing randomized controlled trial (RCT) examined associations between patient-reported adherence, adherence barriers, and mood symptoms among poorly adherent individuals with BD.

methodsRCT participants were adults age ≥ 18 years old with BD Type 1 or 2, difficulties with medication adherence, and actively symptomatic as measured by Brief Psychiatric Rating Scale (BPRS) score ≥ 36, Young Mania Rating Scale (YMRS) > 8, or Montgomery Asberg Depression Rating Scale (MADRS) > 8. Adherence was assessed using the self-reported Tablets Routine Questionnaire (TRQ) and grouped into 3 clinically relevant groups: those with TRQs < 20% (good adherence), ≥ 20% and < 50% (fair adherence), and ≥ 50% (poor adherence). Adherence barriers were assessed with the Oxford Bipolar Knowledge Questionnaire (OBQ), Self-Report Habit Index (SRHI), Communication Styles Scale (CSS), and Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A).

resultsAnalysis was derived from screening and baseline data on the first 129 randomized participants. Mean age was 42.18 (SD = 13.04) years, with 76.74% (n = 99) female and 41.09% (n = 53) non-White. The mean past 7-day percentage of days with missed BD medications using TRQ was 34.34% (SD = 30.32) at screening and 24.82% (SD = 27.70) at baseline. The average time between screening visit and baseline was 18.90 (SD = 12.46) days. Comparing adherence groups, MADRS and BPRS were significantly higher in those with worse adherence both at screening and baseline (p < 0.05 for all). With respect to BD adherence barriers, only SRHI was significantly inversely correlated with TRQ at screening (p < 0.001) and both SRHI and SOCRATES 8A (Taking steps sub-scale) were significantly inversely correlated with TRQ at baseline (p = 0.001 and p = 0.022, respectively).

conclusionsPoorly adherent individuals with BD have significantly more severe global psychopathology and worse depressive severity. Significant adherence barriers include lifestyle routines that do not promote regular medication-taking and engagement in reducing the use of substances. Given the extensive burden of poor adherence in BD, adherence promotion efforts should target specific and actionable barriers.

trial registrationClinicalTrials.gov identifier: NCT04622150.

Indexed as

Bipolar DisorderMedication AdherenceAdultFemaleHumansMaleMiddle AgedPsychiatric Status Rating ScalesSelf ReportSurveys and Questionnairesadherence barriersbipolar disordermanic depressive disordermedication adherence

Identifiers

PMID41220091
PMCPMC12706557

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.