N/A
N=43
Customized Medication Adherence Enhancement for Adults With Bipolar Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00830310 ↗Enrolled (actual)
43
Serious AEs
9.3%
Results posted
Nov 2011
Primary outcome: Primary: Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month) — -23.6 percentage of medication not taken — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychoeducation module (Behavioral); Substance use module (Behavioral); Improved communication/rapport with provider module (Behavioral); Medication routines management module (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month) |
-23.6 | <0.001 sig |
| PRIMARY Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week) |
-17.8 | 0.002 sig |
| PRIMARY Change in Treatment Adherence as Measured by the Morisky Scale |
-1.4 | <0.001 sig |
| SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) |
-3.7 | 0.002 sig |
| SECONDARY Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI) |
-0.67 | 0.001 sig |
| SECONDARY Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI) |
1.7 | 0.001 sig |
| SECONDARY Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF) |
8.2 | 0.001 sig |
| SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D) |
-2.4 | 0.011 sig |
| SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS) |
-3.4 | 0.038 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00830310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.