Evidence map›Paper›PMID 30256551›Full record

Trial reportThe Journal of clinical psychiatry2018

A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder.

Martha Sajatovic, Curtis Tatsuoka, Kristin A Cassidy, Peter J Klein, Edna Fuentes-Casiano, Jamie Cage, Michelle E Aebi, Luis F Ramirez, Carol Blixen, Adam T Perzynski and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00183495 (Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% of its field
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.

NCT00183495 completednot on this map

Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression

TypeobservationalSponsorCase Western Reserve UniversityRan2004 to 2007Enrolled140ConditionsBipolar Disorder
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Patient Factors Influencing Outpatient Retention in Patients with Affective and Anxiety Disorders: A Retrospective Study.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021
    Article
  10. Article
  11. Article
  12. Understanding Aging in Bipolar Disorder by Integrating Archival Clinical Research Datasets.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2019
    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

13 authors at 4 institutions in 1 country.

Martha SajatovicDepartment of Psychiatry, W. O. Walker Bldg, 7th Floor, 10524 Euclid Ave, Cleveland, OH 44106. martha.sajatovic@uhhospitals.org.
Curtis TatsuokaDepartment of Neurology and Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Kristin A CassidyDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Peter J KleinDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Edna Fuentes-CasianoDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Jamie CageDepartment of Social Work, Virginia Commonwealth University, Richmond, Virginia, USA.
Michelle E AebiDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Luis F RamirezDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Carol BlixenDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Adam T PerzynskiCenter for Health Care Research and Policy, Case Western Reserve University, and MetroHealth Medical Center, Cleveland, Ohio, USA.
Mark S BauerCenter for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, and Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.
Steven A SafrenDepartment of Psychology, University of Miami, Miami, Florida, USA.
Jennifer B LevinDepartment of Psychiatry and Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine, and University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Case Western Reserve University · USUniversity of Miami · USUniversity School · USVirginia Commonwealth University · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
Transforming Translational Science and Education to Benefit Human HealthUL1TR000043 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2012 to 2015
$26.8M
Treatment Adherence Enhancement in Bipolar DisorderR01MH093321 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI SAJATOVIC, MARTHA X · 2012 to 2017
$2.8M
NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR002548NIMH NIH HHS R01 MH093321
6 · The paper itself

Abstract

objectiveNonadherence in bipolar disorder (BD) ranges from 20% to 60%. Customized adherence enhancement (CAE) is a brief, BD-specific approach that targets individual adherence barriers. This prospective, 6-month, randomized controlled trial conducted from October 2012 to July 2017 compared CAE versus a rigorous BD-specific educational program (EDU) on adherence, symptoms, and functional outcomes in poorly adherent individuals.

methodsOne hundred eighty-four participants with DSM-IV BD were randomized to CAE (n = 92) or EDU (n = 92). Primary outcome was adherence change measured by the Tablets Routine Questionnaire (TRQ) and BD symptoms measured by the Brief Psychiatric Rating Scale. Other outcomes were scores on the Global Assessment of Functioning, Montgomery-Asberg Depression Rating Scale, Young Mania Rating Scale, and Clinical Global Impressions Scale. Assessments were conducted at screening, baseline, 10 weeks, 14 weeks, and 6 months.

resultsThe sample mean (SD) age was 47.40 (10.46) years; 68.5% were female, and 63.0% were African American. At screening, individuals missed a mean (SD) of 55.15% (28.22%) of prescribed BD drugs within the past week and 48.01% (28.46%) in the past month. Study attrition was < 20%. At 6 months, individuals in CAE had significantly improved past-week (P = .001) and past-month (P = .048) TRQ scores versus those in EDU. Past-week TRQ score improvement remained significant after adjustment for multiple comparisons. There were no treatment arm differences in BPRS scores or other symptoms, possibly related to low symptom baseline values. Baseline-to-6-month comparison showed significantly higher GAF scores (P = .036) for CAE versus EDU. Although both groups used more mental health services at 6 months compared to baseline, increase for CAE was significantly less than that for EDU (P = .046).

conclusionsWhereas both CAE and EDU were associated with improved outcomes, CAE had additional positive effects on adherence, functioning, and mental health resource use compared to EDU.

trial registrationClinicalTrials.gov identifier: NCT00183495.

Indexed as

Drug MonitoringAdultAntipsychotic AgentsBipolar DisorderFemaleHumansLongitudinal StudiesMaleMedication AdherenceMiddle AgedProspective StudiesPsychiatric Status Rating ScalesSelf ReportSingle-Blind MethodTime FactorsAntipsychotic Agents

Identifiers

PMID30256551
PMCPMC6205506
OpenAlexW2893305546

What OpenQuestion holds

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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.