RESUMO
Objective: Managing bipolar disorder (BD) is particularly challenging for adolescents and young adults (AYAs) ages 16 to 21. Few interventions exist that address self-management in AYAs with BD. Thus, this study aimed to modify the customized adherence enhancement behavioral intervention for AYAs through an iterative, patient-centered process. Method: The Obesity-Related Behavioral Intervention Trials (ORBIT) model was used for intervention development. In phase 1a, adherence barriers and facilitators were identified to refine intervention content. Phase 1b occurred following curriculum modification to ensure that the modified intervention was relevant and usable by the target population. Data were collected via focus groups and interviews with AYAs with BD, parents, and providers. Transcripts were analyzed using directed content analysis. Results: Phase 1a included focus groups/interviews with AYAs (n = 10), parents (n = 4), and providers (n = 9) who described the difficulties and successes in managing BD symptoms, improving adherence, and transitioning care from caregivers. Phase 1b included an advisory board composed of 8 phase 1a participants who provided feedback on modified session activities, module delivery, and curriculum. Phase 1b involved usability testing with new participants (n = 8), revealing the need for modifiable language based on developmental level, more engaging visual images, and confirmation that topics were salient to AYAs with BD. Conclusion: Though sample sizes were small and not representative of the population of AYAs with BD, the ORBIT methodology informed the adaptation of the customized adherence enhancement intervention to improve adherence in AYAs with BD. Important next steps are to conduct a pilot randomized clinical trial of customized adherence enhancement for AYAs.
RESUMO
BACKGROUND: The onset of bipolar disorder (BD) is common during late adolescence and young adulthood (AYA). Suboptimal medication adherence is a critical yet modifiable risk factor for negative outcomes among AYAs with BD. METHODS: This research used an iterative process (e.g., focus groups, advisory board, cognitive interviews) to modify an existing adherence intervention to address suboptimal adherence in AYAs with BD. The modified version of Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) will be compared to an Enhanced Treatment as Usual condition (ETAU) in 40 AYAs intervention using a 6-month prospective, randomized controlled trial (RCT) in a high-risk group of 16-21 year old AYAs with BD with demonstrated non-adherence to their prescribed BD medications. CONCLUSIONS: This report describes the methodology and design of the ImprovinG adhereNce In adolescenTs with bipolar disordEr (IGNITE) study. If successful, the CAE-AYA approach has the potential to advance care for vulnerable youth with BD.