Bipolar Disorder Clinical Trial
Official title:
Treatment Adherence Enhancement in Bipolar Disorder
Bipolar disorder (BD) is a serious and chronic mental illness that is associated with
substantial impairment in quality of life and functional outcomes, high rates of suicide, and
high financial costs. In spite of a proliferation of treatments for BD, nearly half of
individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication
treatment adherence. Non-adherence with BD medication treatment dramatically worsens
outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it
has been suggested that adherence enhancement might work best if the intervention
specifically addresses factors that are important and modifiable for a specific individual.
In spite of the enormity of the problem, the literature on interventions to improve treatment
adherence is surprisingly limited. There is an urgent need for interventions to enhance
treatment adherence among BD patients that: 1) are at high risk for future treatment
non-adherence; 2) may not have access to or interest in long-term, high-intensity, and
specialized care; and 3) are flexible and patient-focused taking into account reasons for
non-adherence for a specific individual.
The proposed study is a first-ever RCT focused specifically on BD treatment adherence
enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial
intervention improves adherence and mental health outcomes compared to broadly-directed,
non-individualized education (EDU). The proposed project has the potential to greatly advance
the care of BD patients who are at greatest risk for poor health outcomes, with findings
expected to be generalizable across a variety of treatment settings.
Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared
to broadly-directed, non-individualized BD education (EDU).
Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.
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