NCT04348604

Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 14 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2020-04-16
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

2 sites across 1 country: United States