Improving Adherence in Adolescents and Young Adults With Bipolar Disorder (IGNITE)

Case Western Reserve University

Status: Completed

Conditions: Bipolar Disorder

Treatments: Behavioral: Enhanced Treatment as Usual (ETAU); Behavioral: Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04348604

R34MH117206

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 14 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5)
• Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month
• If < 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if > 18 years, able and willing to provide written informed consent
• Fluent in English

Exclusion criteria

• Unable to receive care in the outpatient setting due to illness severity
• A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder
• Documented or suspected IQ < 70
• Prior enrollment in CAE or Phase 2
• Have recently (in the past month) started a new psychotherapy/behavioral intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Customized Adherence Enhancement for AYA

Experimental group

Description:

This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA).

Treatment:

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

Enhanced Treatment as Usual (ETAU)

Active Comparator group

Description:

This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).

Treatment:

Behavioral: Enhanced Treatment as Usual (ETAU)