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A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid
Jennifer B Levin1,2,3, Farren Briggs4, Carol Blixen5,6
1Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA. jennifer.levin@uhhospitals.org.
Trials
|August 4, 2022
Summary
This study introduces Customized Adherence Enhancement (CAE), a flexible telehealth intervention to improve medication adherence for bipolar disorder patients. CAE addresses individual barriers to treatment, aiming for better health outcomes.
Area of Science:
- Psychiatry and Behavioral Health
- Digital Health Interventions
- Medication Adherence Research
Background:
- Bipolar disorder treatment relies heavily on mood-stabilizing medications.
- Medication non-adherence affects approximately 50% of individuals with bipolar disorder, leading to severe health consequences.
- Telemedicine and virtual care are increasingly recognized as vital for long-term medication adherence.
Purpose of the Study:
- To evaluate the effectiveness of Customized Adherence Enhancement (CAE) as a flexible, telehealth-delivered intervention for improving medication adherence in bipolar disorder.
- To assess the implementation, reach, and adoption of CAE in community mental health settings.
Main Methods:
- CAE is a brief, modular, bipolar-specific approach delivered via telehealth, targeting individual adherence barriers.
- Intervention modules include Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing.
- Participants are assessed over 12 months for adherence, functioning, symptoms, and resource use; qualitative data on implementation are also collected.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The proposed study addresses the need for practical, effective, and flexible adherence interventions adaptable to diverse settings and patient needs.
- By focusing on individuals with bipolar disorder and integrating CAE into public-sector and community mental health workflows, there is significant potential to enhance medication adherence and health outcomes.

