Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

Bipolar Disorder Clinical Trial

— IGNITE  

Official title:

Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348604
• Other study ID #: R34MH117206
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve Universty	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks	The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.	Baseline and 24 weeks
Primary	Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks	The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.	Baseline and 24 weeks
Primary	Change from baseline in treatment adherence as measured by special pill counter at 24 weeks	A special pill cap/box will record the time/date of bottle opening. A dose will be counted as "taken" if the bottle is opened within two hours of the prescribed time. A percent of doses taken (treatment adherence) will be calculated by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.	Baseline and 24 weeks