| Study summary: |
|
Bipolar disorder (BPD) is a chronic disorder characterized by manic and depressive episodes
that disrupt healthy, functional lives. Despite recent advances in medication treatments,
many BPD patients do not take their medications. Medication nonadherence is associated with
multiple risks, such as relapse, rehospitalization, lengthier hospital stays, and, in some
cases, increased risk of suicide. Some studies have shown that treatment adherence in BPD
can be improved, particularly through psychological education, development of
self-management strategies or behaviors, and ongoing relapse prevention.
This study will examine the effectiveness of medication adherence treatment modules
specialized to deal with specific reasons for nonadherence. Participants, all of whom have a
history of medication nonadherence, will undergo structured interviews and complete
self-report questionnaires to determine individual reasons for nonadherence. Based on their
individual profiles, participants will be assigned to one or more of the following
intervention modules:
1. Psychoeducation: This module uses education about BPD and related treatment to address
patient issues such as opposition to preventive efforts, denial of the need for or
effectiveness of medication, negative attitudes toward drugs in general, lack of
information about mood stabilizers, and stigma or embarrassment related to BPD
treatment.
2. Substance abuse: This module targets substance abuse problems that interfere with
medication adherence.
3. Communication with providers: This module addresses fear of medication side effects by
improving communication with health care providers.
4. Medication routines management: This module addresses difficulties establishing a
medication routine and outside opposition to medications by developing strategies for
consistent medication adherence routines.
Each module will involve four 60-minute sessions conducted in a 4- to 6-week period. The
study therapist will conduct each of these sessions individually with the participant,
combining or coadministering modules in a single session if participants are assigned to
more than one module. Depending on which module or modules participants are assigned to,
they may also be contacted by phone one to three times by the therapist to complete all
module materials.
This study will be conducted in two phases. In the first, an initial group of participants
will undergo the module treatments and then participants and therapists will be interviewed
about the effectiveness and feasibility of the interventions. This feedback will be used to
refine the modules. In the second phase, a second group of participants will undergo
treatment in the refined modules and provide more feedback. All participants will continue
with their regular treatment while undergoing module treatments.
Participation in this study will last 4 to 6 weeks, with follow-up interviews and
assessments ending 6 months after completion of the intervention. In all, there will be five
assessments, completed at an initial screening visit, just before treatment, just after
treatment, and 3 and 6 months after the completion of treatment. The initial assessments
will last 60 to 90 minutes and involve questionnaires and a structured interview. The other
four assessments will last 45 to 60 minutes. Treatment adherence, attitudes toward
medications, BPD symptoms, and overall functioning will be measured at each assessment. The
number of pills used in each participant's prescription bottles will also be counted as a
measure of medication adherence. |
| 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) |