Customized Medication Adherence Enhancement for Adults With Bipolar Disorder
NCT ID: NCT00830310
Last Updated: 2014-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2009-01-31
2010-10-31
Brief Summary
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Detailed Description
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All individuals will continue to receive treatment as usual with their regular provider. Those who are enrolled in the study intervention will participate in a series of 4 in-person meetings with the study interventionist over a 4-week time period and 1-2 telephone follow-ups. These meetings with the interventionist will consist of whatever modules were assigned at baseline that are customized to that particular participant's treatment adherence vulnerabilities. A total of 3 to 4 assessment meetings with the research assistant will occur over a three-month time period.
Primary objective The aim of this project is to test the use of a modular-based intervention in a pilot feasibility, acceptability and preliminary efficacy study of customized adherence enhancement (CAE) in a vulnerable population with BPD. We hypothesize that CAE will be: 1) feasible to administer within a academic medical center; 2) acceptable to participants with BPD; and 3) associated with improvements in treatment adherence.
Secondary objectives Individuals who receive CAE will have improvements in BPD symptoms, global psychopathology, overall treatment attitudes and in functional status.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Customized Adherence Enhancement (CAE)
Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the Attitudes toward Mood Stabilizers Questionnaire (AMSQ) and reasons for non-adherence on the Rating of Medication Influences (ROMI).
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.
Psychoeducation module
Individuals will be assigned the psychoeducation module if they are identified as having opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes towards drugs in general, or lack of information about mood stabilizers operationalized as a score of "1" or higher on any of these AMSQ subscales. Additionally, those individuals who are non-adherent/sub-optimally adherent because of stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments will be assigned to participate in the psychoeducation module (ROMI stigma item or complementary/alternative treatment supplemental item).
Substance use module
Individuals will be assigned the substance use module if they endorse the ROMI substance use item or if substance use is identified as problematic on the clinician assessment.
Improved communication/rapport with provider module
Individuals will be assigned the provider communication/rapport module if they are identified as having fear of side effects operationalized as a score of "1" or higher on these AMSQ items. Additionally, those individuals who are non-adherent/suboptimally adherent because of concern regarding change in appearance "appearing medicated" or who experience side-effect-related distress as identified by the ROMI will be assigned the provider communication module.
Medication routines management module
Individuals will be assigned the medication routines management module if they are identified as having difficulties with medication routines operationalized as a score of "1" or higher on this AMSQ sub-scale, or if they are identified as experiencing outside opposition to medications by the ROMI.
Interventions
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Psychoeducation module
Individuals will be assigned the psychoeducation module if they are identified as having opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes towards drugs in general, or lack of information about mood stabilizers operationalized as a score of "1" or higher on any of these AMSQ subscales. Additionally, those individuals who are non-adherent/sub-optimally adherent because of stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments will be assigned to participate in the psychoeducation module (ROMI stigma item or complementary/alternative treatment supplemental item).
Substance use module
Individuals will be assigned the substance use module if they endorse the ROMI substance use item or if substance use is identified as problematic on the clinician assessment.
Improved communication/rapport with provider module
Individuals will be assigned the provider communication/rapport module if they are identified as having fear of side effects operationalized as a score of "1" or higher on these AMSQ items. Additionally, those individuals who are non-adherent/suboptimally adherent because of concern regarding change in appearance "appearing medicated" or who experience side-effect-related distress as identified by the ROMI will be assigned the provider communication module.
Medication routines management module
Individuals will be assigned the medication routines management module if they are identified as having difficulties with medication routines operationalized as a score of "1" or higher on this AMSQ sub-scale, or if they are identified as experiencing outside opposition to medications by the ROMI.
Eligibility Criteria
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Inclusion Criteria
* Demonstrated history of poor adherence as per either self-report or clinician report. In this study, self-reported treatment non-adherence will be identified with Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 20% or more of medication within either the past week or past month (those missing 20% or more within past week will be considered to be non-adherent over the past month).
* BPD for at least two years duration;
* Treatment with atypical antipsychotic medication to stabilize mood for at least six months;
* The ability to participate in psychiatric interviews and to give written, informed consent for study participation; and
* Age 18 or older.
Exclusion Criteria
* Unable/unwilling to give written, informed consent to study participation;
* High risk for suicide (e.g., active suicidal ideation and recent suicide attempt; active suicidal ideation and current intent or plan). In the interest of patient safety, individuals who are acutely suicidal will be excluded from study participation; or
* Individuals who are non-English speaking will be excluded as study assessment tools are not available in other languages and would be impractical to develop in this small, exploratory study.
18 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Martha Sajatovic
Professor of Psychiatry
Principal Investigators
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Martha Sajatovic, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University and University Hospitals Case Medical Center
Locations
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University Hospitals Case Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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L1195
Identifier Type: -
Identifier Source: secondary_id
AZ-IRUSQUET0455
Identifier Type: -
Identifier Source: org_study_id