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Completed

NCT Number: NCT00356304

Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Dysthymic Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Behavioral Healthcare

New Brunswick, New Jersey, 08901, United States

About this study

Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.

Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identifies as Hispanic
  • DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified)
  • Currently taking antidepressant medication

Exclusion criteria

  • Clinically significant suicidal ideation
  • DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry
  • Unstable general medical condition

Treatment and study plan

Motivational Interviewing

Behavioral

Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.

Treatment as Usual

Behavioral

Participants will continue with their normal treatment regimen as usual.

Primary outcomes

  1. Medication Adherence, as Measured by Electronic Pill Container

    Time frame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups

    Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.

Secondary outcomes

  1. Treatment Retention

    Time frame: Measured at Month 5

  2. Beck Depression Inventory-II (BDI-II)

    Time frame: Measured at Month 5

    The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.

    0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.

  3. Medication Attitudes

    Time frame: Measured at Month 5

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 25, 2006
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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