We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00356304
Recruitment Status : Completed
First Posted : July 25, 2006
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Motivational interviewing Behavioral: Treatment as usual Phase 1

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
Study Start Date : April 2006
Primary Completion Date : July 2010
Study Completion Date : July 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Participants will receive motivational interviewing in addition to their antidepressant therapy
Behavioral: Motivational interviewing
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.
Active Comparator: 2
Participants will receive treatment as usual
Behavioral: Treatment as usual
Participants will continue with their normal treatment regimen as usual.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356304


Locations
United States, New Jersey
University Behavioral Healthcare
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Alejandro Interian, PhD Rutgers, The State University of New Jersey
More Information

Publications:
Responsible Party: Alejandro Interian, Ph.D., Adjunct Assistant Professor, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00356304     History of Changes
Other Study ID Numbers: K23MH074860 ( U.S. NIH Grant/Contract )
DSIR 8K-RT
First Posted: July 25, 2006    Key Record Dates
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014
Last Verified: April 2014

Keywords provided by Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH):
Dysthymia
Major Depression
Hispanics
Latinos
Motivational Interviewing
Adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders