Customized Medication Adherence Enhancement for Adults With Bipolar Disorder

University Hospitals Cleveland Medical Center43 enrolled

Overview

This study is a modular intervention that is intended to improve treatment adherence among individuals with bipolar disorder on atypical antipsychotic therapy who have been identified as having treatment adherence problems.

This study is a pilot, prospective project of the effects of customized adherence enhancement (CAE) when added to the medical management (usual care) of outpatients with bipolar disorder (BPD) who are patients at University Hospitals of Cleveland Case Medical Center, and who are known to be at risk for treatment non-adherence. In the proposed trial, CAE is supported by manuals delivered as a series of four modules whose use will be determined based upon an individual's identified treatment adherence vulnerabilities. The modules are components of a single, customized intervention. Although some participants may receive a different combination or number of modules, the participants are neither analyzed separately as a subpopulation nor compared as subpopulations. Therefore participants are all part of a solitary study arm. The effectiveness of the entire customized intervention system is of interest. 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder

Interventions

Psychoeducation moduleBEHAVIORAL

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 moduleBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Bipolar Disorder (BPD) Type I or Type II determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (Sheehan 1998); * 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 participate in psychiatric interviews based on the clinical opinion of the investigator or the treating clinician. Individuals who are grossly psychotic may be excluded at this point if the treating clinician feels that the prospective participant is unable to participate in the interviews or study procedures; * 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.

Locations (1)

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)

Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.