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

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Enhanced Treatment as Usual (ETAU)

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

University of Cincinnati
Case Western Reserve Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Customized Adherence Enhancement for AYA

Enhanced Treatment as Usual (ETAU)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04348604

First Posted

April 14, 2020

Last Updated

September 7, 2023

Sponsor

Case Western Reserve University

1. Study Identification

Unique Protocol Identification Number

NCT04348604

Brief Title

Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

Acronym

IGNITE

Official Title

Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 15, 2021 (Actual)

Primary Completion Date

September 1, 2023 (Actual)

Study Completion Date

September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Customized Adherence Enhancement for AYA

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Treatment as Usual (ETAU)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Treatment as Usual (ETAU)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change from baseline in the Tablet Routine Questionaire (TRQ) "past month" item at 24 weeks

Description

The TRQ "past month" item is a subject report of the percentage of prescribed medications not taken within the past month.

Time Frame

Baseline and 24 weeks

Title

Change from baseline in the Tablet Routine Questionaire (TRQ) "past week" item at 24 weeks

Description

The TRQ "past week" item is a subject report of the percentage of prescribed medications not taken within the past week.

Time Frame

Baseline and 24 weeks

Title

Change from baseline in treatment adherence as measured by special pill counter at 24 weeks

Description

Time Frame

Baseline and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martha Sajatovic, MD

Organizational Affiliation

Case Western Reserve University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Case Western Reserve Universty

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data entered into the NIMH National Database: We will collaborate with our project office to determine the best mechanism to ensure that our Phase 3 data is entered into the common informatics platform by NIMH, called the National Database for Clinical Trials Related to Mental Illness (http://ndct.nimh.nih.gov, NDCT). We will work with NIMH to transform the data we collect into relevant information using the suggested consent form language, NIMH software that will create global unique identifiers and a useful data dictionary as much as we are able in order to deposit data into the National Database allowing other researchers and NIMH to use available data. In line with accepted data sharing practices and ethical principles, we will share de-identified raw data with other researchers attempting to replicate our findings or including our findings in subsequent projects.

IPD Sharing Time Frame

One year after the final results have been published.

IPD Sharing Access Criteria

Researchers will be able to contact us by telephone or email to request these data, which we will provide in a timely manner. We will not release any data that are considered identifying or protected by IRB, HIPAA, or federal regulations unless that researcher and the PI of the current project have obtained proper administrative agreements or participation in the NIMH national database.

Learn more about this trial

Improving Adherence in Adolescents and Young Adults With Bipolar Disorder

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