NCT04622150Completed
Effectiveness RCT of Customized Adherence Enhancement
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 30 Sept 2020
- Start date
- 1 Feb 2022
- Primary completion date
- 15 May 2026
- Lead sponsor
- Case Western Reserve University
- Diseases
- Bipolar disorder
- NCT number
- NCT04622150
What you commit to
- Study type: Interventional
- Participants enrolled: 190
- From 1 Feb 2022 to the primary completion date, 15 May 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
Age
- Children under the age of 18
Other
- Unable or unwilling to give written, informed consent to study participation
- Individuals who participated in Phase 1 of the study
- Individuals at high risk for suicide who cannot be safely managed in their current treatment setting
Who the study is looking for
- 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
Criteria the registry did not label
- Patients receiving care at the Nord Center, MetroHealth system, and other not-for-profit health systems.
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| W.O. Walker Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Nord Center Coordinator of this site? Confirm its status | Lorain | United States | Unknown status |
Related publications
- Association Between Adherence Barriers, Self-Reported Adherence, and Psychiatric Symptoms Among Adults With Bipolar Disorder.Bipolar Disord · 2025 · PMID 41220091
This page is information, not medical advice. Discuss any trial with your doctor.