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A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid

Jennifer B Levin^1,2,3, Farren Briggs⁴, Carol Blixen^5,6

¹Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA. jennifer.levin@uhhospitals.org.

|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.

Keywords:

Bipolar disorder Manic-depressive disorder Medication adherence Randomized controlled trial Telehealth

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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.