N/A N=43 Treatment

Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00763919 ↗

Enrolled (actual)

Serious AEs

18.6%

Results posted

Dec 2011

Primary outcome: Primary: Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire — -27.8 units on a scale — p=<.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Psychoeducation module (Behavioral); Substance abuse module (Behavioral); Improved communication/rapport with provider module (Behavioral); Medication routines management module (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Case Western Reserve University
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire	-28.9	<.001 sig
PRIMARY Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire	-21.8	.002 sig
PRIMARY Change in Treatment Adherence as Measured by the Morisky Scale	-1.7	<.001 sig
PRIMARY Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire	-28.9	<.001 sig
PRIMARY Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire	-21.8	.002 sig
SECONDARY Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)	-3.2	<.001 sig
SECONDARY Change in Attitude as Measured by the Rating of Medication Influences (ROMI)	-1.6	.078
SECONDARY Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)	-1.4	.246
SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)	-2.8	.101
SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)	-6.6	.003 sig
SECONDARY Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)	-.47	.096
SECONDARY Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale	3.5	.072
SECONDARY Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)	1.1	.562
SECONDARY Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)	3.8	.12
SECONDARY Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)	-1.4	.246
SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)	-2.8	.101
SECONDARY Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)	-6.6	.003 sig
SECONDARY Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)	-.47	.096
SECONDARY Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale	3.5	.072
SECONDARY Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)	-3.2	<.001 sig
SECONDARY Change in Attitude as Measured by the Rating of Medication Influences (ROMI)	-1.6	.078
SECONDARY Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)	1.1	.562
SECONDARY Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)	3.8	.12

Summary

In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be nonadherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
BPD of at least 2 years' duration
Treatment with medication to stabilize mood for at least 6 months

Exclusion Criteria

Unable/unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current intent or plan
Inability to speak English
Individuals who have participated in Project 1, Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00763919). 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.