Effectiveness RCT of Customized Adherence Enhancement

Description

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

Bipolar Disorder

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Study Overview

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Study Details

Study overview

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.

Effectiveness RCT of Customized Adherence Enhancement

Effectiveness RCT of Customized Adherence Enhancement

Condition
Bipolar Disorder
Intervention / Treatment

-

Contacts and Locations

Cleveland

MetroHealth Medical Center, Cleveland, Ohio, United States, 44109

Lorain

The Nord Center, Lorain, Ohio, United States, 44053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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).
  • 2. Have had BD for at least two years duration
  • 3. Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
  • 4. Yes to either of the following questions:
  • 1. Do you ever have any trouble taking all of your medications? Or
  • 2. Do you ever try to cope on your own without medication?
  • 5. a BPRS ≥ 36 or YRMS ≥8 or MADRS ≥8
  • 6. Be able to participate in psychiatric interviews and give written informed consent
  • 7. Have their own cellular phone in order to receive text messages as part of the intervention
  • 1. Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
  • 2. Unable or unwilling to give written, informed consent to study participation
  • 3. Individuals who participated in Phase 1 of the study
  • 4. Children under the age of 18
  • 5. Individuals at high risk for suicide who cannot be safely managed in their current treatment setting

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Western Reserve University,

Martha Sajatovic, MD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

2026-05-01