Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

NACompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 15, 2021

Primary Completion Date

September 1, 2023

Study Completion Date

September 1, 2023

Conditions
Bipolar Disorder
Interventions
BEHAVIORAL

Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)

"Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one booster in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the booster session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers \& Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience."

BEHAVIORAL

Enhanced Treatment as Usual (ETAU)

Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes).

Trial Locations (2)

44106

Case Western Reserve Universty, Cleveland

45219

University of Cincinnati, Cincinnati

All Listed Sponsors
lead

Case Western Reserve University

OTHER

NCT04348604 - Improving Adherence in Adolescents and Young Adults With Bipolar Disorder | Biotech Hunter | Biotech Hunter