N/A
N=36
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04348604 ↗Enrolled (actual)
36
Serious AEs
8.3%
Results posted
Oct 2024
Primary outcome: Primary: Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks — 21.5; 28.0 percent of medications not taken
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) (Behavioral); Enhanced Treatment as Usual (ETAU) (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks |
21.5; 28.0 | — |
| PRIMARY Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks |
27.9; 28.6 | — |
| PRIMARY Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks |
85.7; 50.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 provide written informed consent
- Fluent in English
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04348604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.