Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients
Status: | Completed |
---|---|
Conditions: | Psychiatric, Bipolar Disorder |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/2/2017 |
Start Date: | April 2008 |
End Date: | January 2009 |
Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
This study will attempt to increase understanding of why bipolar disorder patients do or do
not take their medications by conducting in-depth interviews with them.
not take their medications by conducting in-depth interviews with them.
Disruptive manic and depressive episodes prevent bipolar disorder (BPD) sufferers from
living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with
approximately half of those relapses occurring in the first 2 years after remission. High
rates of relapse and no substantial improvements in illness outcomes for many patients
despite advances in drug treatment may be related to a common problem: medication
nonadherence. Nine in 10 individuals with BPD have seriously considered medication
withdrawal, and one third of individuals with BDP do not take 30% or more of their
prescribed medications. The researchers in this study will identify BPD patients who do not
take their medications as prescribed and conduct interviews with them. By obtaining an
understanding of subjective reasons for medication nonadherence, this study will pave the
way for better interventions to ensure BDP patients take the medications that will help
them.
Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours.
All participants will have a history of medication nonadherence. Participants will be asked
to fill out questionnaires and undergo a structured interview with a researcher. The
interview will be audio recorded. The questionnaires and interview will assess BPD symptoms,
attitudes toward medications, and to what extent patients are taking their medications.
Researchers will also measure the number of pills used in participants' prescriptions by
counting how many pills are left in each prescription bottle.
living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with
approximately half of those relapses occurring in the first 2 years after remission. High
rates of relapse and no substantial improvements in illness outcomes for many patients
despite advances in drug treatment may be related to a common problem: medication
nonadherence. Nine in 10 individuals with BPD have seriously considered medication
withdrawal, and one third of individuals with BDP do not take 30% or more of their
prescribed medications. The researchers in this study will identify BPD patients who do not
take their medications as prescribed and conduct interviews with them. By obtaining an
understanding of subjective reasons for medication nonadherence, this study will pave the
way for better interventions to ensure BDP patients take the medications that will help
them.
Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours.
All participants will have a history of medication nonadherence. Participants will be asked
to fill out questionnaires and undergo a structured interview with a researcher. The
interview will be audio recorded. The questionnaires and interview will assess BPD symptoms,
attitudes toward medications, and to what extent patients are taking their medications.
Researchers will also measure the number of pills used in participants' prescriptions by
counting how many pills are left in each prescription bottle.
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 non-adherent 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
- A Clinical Global Impression (CGI-BP) overall bipolar illness score of 4 or higher
Exclusion Criteria:
- Unable or 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 suicidal intent or plan
- Inability to speak English
- Receiving treatment involuntarily
We found this trial at
1
site
Click here to add this to my saved trials