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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized Adherence Enhancement for AYA | Experimental | This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA). |
|
| Enhanced Treatment as Usual (ETAU) | Active Comparator | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States | ||
| Case Western Reserve Universty |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39231780 | Derived | Levin JB, DelBello M, Modi AC, Briggs F, Forthun LF, McVoy M, Yala J, Cooley R, Black J, Conroy C, Sajatovic M. A 6-month, prospective, randomized controlled trial of customized adherence enhancement versus a bipolar-specific educational control in poorly adherent adolescents and young adults living with bipolar disorder. Bipolar Disord. 2024 Nov;26(7):696-707. doi: 10.1111/bdi.13489. Epub 2024 Sep 4. |
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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.
One year after the final results have been published.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Customized Adherence Enhancement for AYA | This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA). 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. |
| FG001 | Enhanced Treatment as Usual (ETAU) | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Randomized) |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Customized Adherence Enhancement for AYA | This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only those with complete data for TRQ past month at baseline and 24 weeks were included in the analysis | Posted | Mean | Standard Deviation | percent of medications not taken | Baseline and 24 weeks |
|
Adverse events were collected during the study period of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Customized Adherence Enhancement for AYA | This arm will receive the experimental intervention, Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy Yala, Data Manager | Case Western Reserve University | 216-368-0783 | jxy790@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2022 | Aug 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: NCT04348604 Assent | Dec 8, 2023 | Apr 28, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: NCT04348604 Consent | Dec 8, 2023 | Apr 28, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Enhanced Treatment as Usual (ETAU) | Behavioral | 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). |
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Enhanced Treatment as Usual (ETAU) | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Age diagnosed with Bipolar Disorder | Mean | Standard Deviation | years |
|
| Current living situation | Count of Participants | Participants |
|
| Household income | Count of Participants | Participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| Hospitalization history | Count of Participants | Participants |
|
| Family History of Bipolar Disorder | Count of Participants | Participants |
|
| Attention-deficit/hyperactivity disorder Diagnosis | Count of Participants | Participants |
|
| OG001 | Enhanced Treatment as Usual (ETAU) | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). 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). |
|
|
| 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. | Only those with complete data for TRQ past week at baseline and 24 weeks were included in the analysis | Posted | Mean | Standard Deviation | percent of medications not taken | Baseline and 24 weeks |
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| 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. | Only those with complete data from the pill counter at baseline and 24 weeks were included in the analysis. | Posted | Mean | Standard Deviation | percentage of doses taken | Baseline and 24 weeks |
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| 0 |
| 17 |
| 3 |
| 17 |
| 0 |
| 17 |
| EG001 | Enhanced Treatment as Usual (ETAU) | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). 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). | 0 | 19 | 0 | 19 | 0 | 19 |
| Hospitalization for Severe Electrolyte Imbalance | General disorders | Non-systematic Assessment |
|
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