Effectiveness RCT of Customized Adherence Enhancement

Completed · Not applicable

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT04622150

Run by

Case Western Reserve University

People needed

190

Starts

2022-02-01

Expected to finish

2026-05-15

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Have their own cellular phone in order to receive text messages as part of the intervention

You may not qualify if…

• Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
• Unable or unwilling to give written, informed consent to study participation
• Individuals who participated in Phase 1 of the study
• Children under the age of 18
• Individuals at high risk for suicide who cannot be safely managed in their current treatment setting

Where it is running

• W.O. Walker Center — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• The Nord Center — Lorain, Ohio, United States

Full record on ClinicalTrials.gov

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