Effectiveness RCT of Customized Adherence Enhancement

NAActive, not recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

November 1, 2025

Study Completion Date

May 1, 2026

Conditions
Bipolar Disorder
Interventions
BEHAVIORAL

Customized Adherence Enhancement (CAE)

CAE is comprised of a series of up to four treatment modules whose inclusion is determined based upon an individuals reasons for nonadherence (adherence barriers).The standardized modules are Psychoeducation, Modified Motivational Interviewing, Communication with Providers, Medication Routines. CAE participants will have a core series of approximately four sessions spaced about one week apart over a period of 4-6 weeks, and one booster in-person session 4 weeks after the completion of the four core sessions (total of approximately 5 sessions). Sessions 2-4 will be delivered remotely by the study interventionist. All participants will have the first session in-person. The final booster session will be conducted at the sites and will review all previously introduced materials. There will be a follow-up phone call with the study interventionist that will occur in the four-week time period between completion of four CAE core sessions and prior to initiation of the booster CAE session.

BEHAVIORAL

Enhanced Treatment as Usual (eTAU)

eTAU participants will receive monthly text messages (or phone calls for participants who prefer not to receive texts) to refill medications, fill eCAPs and brief general adherence promotion messages during the follow-up period.

Trial Locations (3)

44053

The Nord Center, Lorain

44106

W.O. Walker Center, Cleveland

44109

MetroHealth Medical Center, Cleveland

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Case Western Reserve University

OTHER