Effectiveness RCT of Customized Adherence Enhancement
United States190 participantsStarted 2022-02-01
Plain-language summary
Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Building upon positive efficacy trial results, the proposed project will test the effectiveness of technology-facilitated Customized Adherence Enhancement (CAE) vs. enhanced treatment as usual (eTAU) using a prospective randomized controlled design in public mental health care settings and preferentially enrolling poorly adherent/high-risk individuals with BD. Deliverables include a curriculum-driven adherence enhancement approach that can be implemented in public healthcare settings and which can improve outcomes for the most vulnerable groups of people with BD.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. Participants will have a diagnosis of Bipolar Disorder Type I or Type II determined by the Structured Clinical Interview for DSM-5 patient version (SCID-P).
✓. Have had BD for at least two years duration
✓. Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
✓. Yes to either of the following questions:
✓. Do you ever have any trouble taking all of your medications? Or
✓. Do you ever try to cope on your own without medication?
✓. a BPRS ≥ 36 or YRMS ≥8 or MADRS ≥8
✓. Be able to participate in psychiatric interviews and give written informed consent
Exclusion criteria
✕. Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
What they're measuring
1
Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 6 months
Timeframe: Baseline and 6 Months; extension phase will be Baseline up to 12 months
2
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 6 months
Timeframe: Baseline and 6 Months; extension phase will be Baseline up to 12 months
3
Change from baseline in treatment adherence as measured by electronic pill monitoring (eCAPS) at 6 months
Timeframe: Baseline and 6 Months; extension phase will be Baseline up to 12 months