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

Primary Purpose

Bipolar Disorder, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring adherence, adolescent, Motivational Intervention

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Western Psychiatric Institute and Clinic / University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care (SC)

SC + Brief Motivational Intervention

Arm Description

Standard Care (SC) in a specialty mood disorders clinic for youth with mood disorders.

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

Outcomes

Primary Outcome Measures

Objective Medication Adherence
Medication adherence via electronic pillbox
Subjective Medication Adherence
Self-reported medication adherence

Secondary Outcome Measures

Mood disorder symptoms
Depressive and manic symptoms as measured via semi-structured interview

Full Information

First Posted
June 23, 2017
Last Updated
February 2, 2021
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03203720
Brief Title
Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder
Acronym
BMI
Official Title
Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2011 (Actual)
Primary Completion Date
December 30, 2014 (Actual)
Study Completion Date
December 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Medication Adherence
Keywords
adherence, adolescent, Motivational Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial comparing Brief Motivational Intervention + Standard Care versus Standard Care Alone
Masking
Outcomes Assessor
Masking Description
Outcomes assessors blind to treatment group of participants.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care (SC)
Arm Type
No Intervention
Arm Description
Standard Care (SC) in a specialty mood disorders clinic for youth with mood disorders.
Arm Title
SC + Brief Motivational Intervention
Arm Type
Experimental
Arm Description
Standard Care (SC) in a specialty mood disorders clinic plus a Brief Motivational Intervention (BMI) targeting medication adherence.
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention
Other Intervention Name(s)
BMI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Medication Adherence
Description
Medication adherence via electronic pillbox
Time Frame
6 months
Title
Subjective Medication Adherence
Description
Self-reported medication adherence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mood disorder symptoms
Description
Depressive and manic symptoms as measured via semi-structured interview
Time Frame
Quarterly over 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 12 years, 0 months to 22 years, 11 months; a diagnosis of BP spectrum disorder via semi-structured interview; willing to engage in treatment at the BP specialty clinic; English fluency and understanding, as the study consists of interviews and surveys that necessitate English fluency and understanding; able and willing to give informed consent/assent to participate. Exclusion Criteria: evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by semi-structured interview, parent report, medical history, or school records; a life-threatening medical condition requiring immediate treatment; current victim of sexual or physical abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina R Goldstein, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic / University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31957686
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.
Results Reference
derived

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

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