CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Psychoeducation module +3 morebehavioral
Likely dose
Not stated in record
Key inclusion· 6
  • Clinical diagnosis of Bipolar Disorder Type I or Type II confirmed by standardized interview (MINI)
  • Documented poor medication adherence (≥20% missed doses in past week or month)
  • BPD duration of at least 2 years
  • Treatment with atypical antipsychotic for mood stabilization for at least 6 months
Key exclusion· 4
  • Unable or unwilling to participate in psychiatric interviews; individuals with active gross psychosis may be excluded if clinically deemed unable to participate
  • Unable or unwilling to provide written informed consent
  • High suicide risk, including active suicidal ideation with recent attempt or current intent/plan
  • Non-English speaking

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00830310
NCT00830310N/ACompleted

Customized Adherence Enhancement (CAE) Among Individuals With Bipolar Disorder

University Hospitals Cleveland Medical Center·interventional·Posted Jan 27, 2009·Updated Dec 30, 2014

In Brief

A clinical study evaluating Psychoeducation module, Substance use module, and 2 other interventions for Bipolar Disorder. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2009
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.4 years ago

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 modulebehavioral

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 modulebehavioral

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.