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

NCT03203720 | Completed

• 1 other identifier: MH092424
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Medication Adherence

Keywords

adherence; adolescent; Motivational Intervention

Outcome Measures

Primary Outcomes (2)

• Objective Medication Adherence

  Medication adherence via electronic pillbox

  6 months

• Subjective Medication Adherence

  Self-reported medication adherence

  6 months

Secondary Outcomes (1)

• Mood disorder symptoms

  Quarterly over 6 months

Study Arms (2)

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.

Behavioral: Brief Motivational Intervention

Interventions

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.

Also known as: BMI

SC + Brief Motivational Intervention

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Western Psychiatric Institute and Clinic / University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 31957686 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Medication Adherence

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Tina R Goldstein, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors blind to treatment group of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized trial comparing Brief Motivational Intervention + Standard Care versus Standard Care Alone

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 29, 2017
• Study Start: July 11, 2011
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2014
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)