Effectiveness RCT of Customized Adherence Enhancement
CAE-E
2 other identifiers
interventional
190
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 28, 2026
April 1, 2026
4.3 years
September 30, 2020
April 26, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 6 months
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Baseline and 6 Months; extension phase will be Baseline up to 12 months
Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 6 months
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Baseline and 6 Months; extension phase will be Baseline up to 12 months
Change from baseline in treatment adherence as measured by electronic pill monitoring (eCAPS) at 6 months
A special pill cap (eCAPS) will record bottle openings. Adherence is defined as the percentage of pills missed, with a higher value indicating poorer adherence.
Baseline and 6 Months; extension phase will be Baseline up to 12 months
Secondary Outcomes (5)
change in Global Assessment of Functioning (GAF)
Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Brief Psychiatric Rating Scale (BPRS)
Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Young Mania Rating Scale (YMRS)
Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Montgomery Asberg Depression Rating Scale (MADRS)
Baseline and 6 Months; extension phase will be Baseline up to 12 months
change in Clinical Global Impressions Scale (CGI)
Baseline and 6 Months; extension phase will be Baseline up to 12 months
Study Arms (2)
Customized Adherence Enhancement (CAE)
EXPERIMENTALThis arm will receive the experimental intervention, Customized Adherence Enhancement (CAE).
Enhanced Treatment as Usual (eTAU)
ACTIVE COMPARATORThis arm will receive the control intervention, Enhanced Treatment as Usual (eTAU).
Interventions
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
W.O. Walker Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
The Nord Center
Lorain, Ohio, 44053, United States
Related Publications (3)
Sajatovic M, Levin JB, Adeniyi C, Black J, Weise C, Fiorelli N, Kelley E, Einstadter D, Bauer M, Briggs FBS. Association Between Adherence Barriers, Self-Reported Adherence, and Psychiatric Symptoms Among Adults With Bipolar Disorder. Bipolar Disord. 2025 Dec;27(8):567-577. doi: 10.1111/bdi.70067. Epub 2025 Nov 11.
PMID: 41220091DERIVEDSajatovic M, Briggs F, Adeniyi C, Koopman J, Black J, Weise C, Fiorelli N, Yala J, Lesanpezeshki M, Einstadter D, Levin JB. Association Between Symptom Severity and Medication Adherence in Adults with Bipolar Disorder Reporting Adherence Challenges. Psychopharmacol Bull. 2024 Jul 8;54(3):60-72. doi: 10.64719/pb.4494.
PMID: 38993661DERIVEDLevin JB, Briggs F, Blixen C, Bauer M, Einstadter D, Albert JM, Weise C, Woods N, Fuentes-Casiano E, Cassidy KA, Rentsch J, Sarna K, Sajatovic M. A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project. Trials. 2022 Aug 4;23(1):634. doi: 10.1186/s13063-022-06517-0.
PMID: 35927740DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha Sajatovic, MD
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 30, 2020
First Posted
November 9, 2020
Study Start
February 1, 2022
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- No later than time of publication, and will be made available for 24 months.
- Access Criteria
- Researchers will be able to contact us by telephone or email to request these data, which we will provide in a timely manner. We will not release any data that are considered identifying or protected by IRB, HIPAA, or federal regulations unless that researcher and the PIs of the current project have obtained proper administrative agreements or participation in the NIMH national database.
We will collaborate with our project office to determine the best mechanism to ensure that our study data is entered into the common informatics platform by NIMH, called the National Database for Clinical Trials Related to Mental Illness (http://ndct.nimh.nih.gov, NDCT). We will work with NIMH to transform the data we collect into relevant information using the suggested consent form language, NIMH software that will create global unique identifiers and a useful data dictionary as much as we are able in order to deposit data into the National Database allowing other researchers and NIMH to use available data. In line with accepted data sharing practices and ethical principles, we will share de-identified raw data with other researchers attempting to replicate our findings or including our findings in subsequent projects.