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Adolescence is the peak onset period for serious and persistent psychiatric disorders. Treatment guidelines for management of major psychiatric disorders in youth include pharmacotherapy. There has been substantial progress in recent years in identifying effective medications for youth with psychiatric disorders. However, adherence to prescribed medications among psychiatric populations is notoriously low, and adolescents rank among the least adherent of all patient populations. Given that the consequences of poor medication adherence among youth with chronic mental illness are far-reaching, including hospitalization, poor functioning, and suicide, there is a desperate need for interventions targeting medication adherence in this population.
Adolescence is the peak period of onset for serious and persistent psychiatric disorders. Treatment guidelines for the management of major psychiatric disorders in adolescence indicate pharmacotherapy is a critical element of effective treatment. Unfortunately, adolescence is a particularly vulnerable window for poor medication adherence, and little is known about the timecourse and specific factors associated with poor medication adherence in this population. Given that the consequences of poor medication adherence among youth with chronic mental illness are far-reaching, and include hospitalization, profound functional impairment and even suicide, there is a desperate need for interventions targeting medication adherence in this population. Motivational Interviewing (MI) is an evidence-based approach focused on enhancing motivation for change. This model holds great promise for improving medication adherence in adolescents with psychiatric disorders because it is developmentally sensitive, acceptable to patients and providers, and readily disseminable across clinical settings. Research demonstrates that brief motivational interventions (BMIs) utilizing a MI approach result in improved treatment adherence among youth with a variety of chronic medical conditions. Although widely applied for adolescent substance use behaviors, BMIs have yet to be examined for improving medication adherence in youth with severe psychiatric disorders. Adolescents with bipolar disorder (BP) are an ideal population with whom to develop a BMI for medication adherence because adolescents with BP are among the least adherent of any psychiatric population. Experience developing a BMI for this challenging population will directly inform intervention for youth with a range of chronic psychiatric disorders. The purpose of the proposed study is to conduct a small randomized trial comparing CABS Standard Care (SC) augmented with the BMI versus SC alone. Outcomes will be assessed monthly over 6 months. Participants will include 40 adolescents with BP. This approach is in direct accord with the National Institute of Mental Health (NIMH) Strategic Plan in which the development and testing of innovative interventions to reduce risk and positively alter trajectories of mental illness are informed by research findings regarding robust and malleable risk factors. Research in this area is of great public health importance, as it has the potential to lessen costs, disrupt the cycle of poor outcomes, and minimize the long-term debilitating effects of these serious disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care (SC) | No Intervention | Standard Care (SC) in a specialty mood disorders clinic for youth with mood disorders. | |
| SC + Brief Motivational Intervention | Experimental | Standard Care (SC) in a specialty mood disorders clinic plus a Brief Motivational Intervention (BMI) targeting medication adherence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Motivational Intervention | Behavioral | A brief motivational intervention centered around Motivational Interviewing (MI) techniques. Sessions are adjunct to standard clinical care, and focus on psychoeducation regarding treatment for bipolar disorder, and resolving ambivalence regarding taking medications for mood disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Medication Adherence | Medication adherence via electronic pillbox | 6 months |
| Subjective Medication Adherence | Self-reported medication adherence | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mood disorder symptoms | Depressive and manic symptoms as measured via semi-structured interview | Quarterly over 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina R Goldstein, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic / University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31957686 | Derived | Goldstein TR, Krantz ML, Fersch-Podrat RK, Hotkowski NJ, Merranko J, Sobel L, Axelson D, Birmaher B, Douaihy A. A brief motivational intervention for enhancing medication adherence for adolescents with bipolar disorder: A pilot randomized trial. J Affect Disord. 2020 Mar 15;265:1-9. doi: 10.1016/j.jad.2020.01.015. Epub 2020 Jan 7. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
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Randomized trial comparing Brief Motivational Intervention + Standard Care versus Standard Care Alone
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Outcomes assessors blind to treatment group of participants.
|
|
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |