Clinical trial NCT03203720: Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder
Official title: Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Medication Adherence
Keywords: adherence
adolescent
Motivational Intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial comparing Brief Motivational Intervention + Standard Care versus Standard Care Alone
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. age 12 years, 0 months to 22 years, 11 months;
2. a diagnosis of BP spectrum disorder via semi-structured interview;
3. willing to engage in treatment at the BP specialty clinic;
4. English fluency and understanding, as the study consists of interviews and surveys that necessitate English fluency and understanding;
5. able and willing to give informed consent/assent to participate.

Exclusion Criteria:

1. evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by semi-structured interview, parent report, medical history, or school records;
2. a life-threatening medical condition requiring immediate treatment;
3. current victim of sexual or physical abuse.

Primary outcomes:
measure: Objective Medication Adherence
timeFrame: 6 months
measure: Subjective Medication Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Mood disorder symptoms
timeFrame: Quarterly over 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic / University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tina R Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.