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Effectiveness RCT of Customized Adherence Enhancement

NCT04622150 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Customized Adherence Enhancement (CAE)

CAE is comprised of a series of up to four treatment modules whose inclusion is determined based upon an individuals reasons for nonadherence (adherence barriers).The standardized modules are Psychoeducation, Modified Motivational Interviewing, Communication with Providers, Medication Routines. CAE participants will have a core series of approximately four sessions spaced about one week apart over a period of 4-6 weeks, and one booster in-person session 4 weeks after the completion of the four core sessions (total of approximately 5 sessions). Sessions 2-4 will be delivered remotely by the study interventionist. All participants will have the first session in-person. The final booster session will be conducted at the sites and will review all previously introduced materials. There will be a follow-up phone call with the study interventionist that will occur in the four-week time period between completion of four CAE core sessions and prior to initiation of the booster CAE session.

BEHAVIORAL

Enhanced Treatment as Usual (eTAU)

eTAU participants will receive monthly text messages (or phone calls for participants who prefer not to receive texts) to refill medications, fill eCAPs and brief general adherence promotion messages during the follow-up period.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Martha Sajatovic, MD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-05-15
Completion
2026-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622150 on ClinicalTrials.gov