Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00356304
First received: July 21, 2006
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Motivational interviewing
Behavioral: Treatment as usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Medication adherence, as measured by electronic pill container [ Time Frame: Measured immediately post-treatment and at Months 2 and 5 follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment retention [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Medication attitudes [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356304

Contacts
Contact: Alejandro Interian, PhD 732-235-3959 interial@umdnj.edu
Contact: Lina Aldana, PsyM 732-235-5908 aldanalm@umdnj.edu

Locations
United States, New Jersey
University Behavioral Healthcare Recruiting
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Investigators
Principal Investigator: Alejandro Interian, PhD Rutgers, The State University of New Jersey
  More Information

Publications:
Responsible Party: Alejandro Interian, PhD, UMDNJ--Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00356304     History of Changes
Other Study ID Numbers: K23 MH074860, DSIR 8K-RT
Study First Received: July 21, 2006
Last Updated: March 12, 2009
Health Authority: United States: Federal Government

Keywords provided by 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
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014