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BMI: Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT03203720
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
41.7
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief Motivational Intervention
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized trial comparing Brief Motivational Intervention + Standard Care versus Standard Care AloneRandomized trial comparing Brief Motivational Intervention + Standard Care versus Standard Care Alone
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessors blind to treatment group of participants.
Primary Purpose:
Treatment
Official Title:
Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder
Actual Study Start Date :
Jul 11, 2011
Actual Primary Completion Date :
Dec 30, 2014
Actual Study Completion Date :
Dec 30, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care (SC)

Standard Care (SC) in a specialty mood disorders clinic for youth with mood disorders.
Experimental: SC + Brief Motivational Intervention

Standard Care (SC) in a specialty mood disorders clinic plus a Brief Motivational Intervention (BMI) targeting medication adherence.

Behavioral: Brief Motivational Intervention
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.
Other Names:
  • BMI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Medication Adherence [6 months]

      Medication adherence via electronic pillbox

    2. Subjective Medication Adherence [6 months]

      Self-reported medication adherence

    Secondary Outcome Measures

    1. Mood disorder symptoms [Quarterly over 6 months]

      Depressive and manic symptoms as measured via semi-structured interview

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Western Psychiatric Institute and Clinic / University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh

    Investigators

    • Principal Investigator: Tina R Goldstein, PhD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tina R Goldstein, Associate Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT03203720
    Other Study ID Numbers:
    • MH092424
    First Posted:
    Jun 29, 2017
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tina R Goldstein, Associate Professor, University of Pittsburgh
    adherence
    adolescent
    Motivational Intervention
    Additional relevant MeSH terms:
    Bipolar Disorder

    Study Results

    No Results Posted as of Feb 3, 2021