Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
IGNITE
1 other identifier
interventional
36
1 country
2
Brief Summary
Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedResults Posted
Study results publicly available
October 10, 2024
CompletedMay 19, 2026
April 1, 2026
2.5 years
April 14, 2020
August 30, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.
Baseline and 24 weeks
Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks
The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.
Baseline and 24 weeks
Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks
A special pill cap/box will record the time/date of bottle opening. A dose will be counted as "taken" if the bottle is opened within two hours of the prescribed time. A percent of doses taken (treatment adherence) will be calculated by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Baseline and 24 weeks
Study Arms (2)
Customized Adherence Enhancement for AYA
EXPERIMENTALThis arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA).
Enhanced Treatment as Usual (ETAU)
ACTIVE COMPARATORThis arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).
Interventions
Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one "booster" in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the "booster" session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers \& Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience.
Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes).
Eligibility Criteria
You may qualify if:
- DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5)
- Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month
- If \< 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if \> 18 years, able and willing to provide written informed consent
- Fluent in English
You may not qualify if:
- Unable to receive care in the outpatient setting due to illness severity
- A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder
- Documented or suspected IQ \< 70
- Prior enrollment in CAE or Phase 2
- Have recently (in the past month) started a new psychotherapy/behavioral intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Case Western Reserve Universty
Cleveland, Ohio, 44106, United States
Related Publications (1)
Levin JB, DelBello M, Modi AC, Briggs F, Forthun LF, McVoy M, Yala J, Cooley R, Black J, Conroy C, Sajatovic M. A 6-month, prospective, randomized controlled trial of customized adherence enhancement versus a bipolar-specific educational control in poorly adherent adolescents and young adults living with bipolar disorder. Bipolar Disord. 2024 Nov;26(7):696-707. doi: 10.1111/bdi.13489. Epub 2024 Sep 4.
PMID: 39231780DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joy Yala, Data Manager
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Martha Sajatovic, MD
Case Western Reserve University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
April 14, 2020
First Posted
April 16, 2020
Study Start
March 15, 2021
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
May 19, 2026
Results First Posted
October 10, 2024
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- One year after the final results have been published.
- 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 PI of the current project have obtained proper administrative agreements or participation in the NIMH national database.
Data entered into the NIMH National Database: We will collaborate with our project office to determine the best mechanism to ensure that our Phase 3 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.