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Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00356304
First received: July 21, 2006
Last updated: April 10, 2014
Last verified: April 2014
  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 Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Medication Adherence, as Measured by Electronic Pill Container [ Time Frame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups ] [ Designated as safety issue: No ]
    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:
  • Treatment Retention [ Time Frame: Measured at Month 5 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Measured at Month 5 ] [ Designated as safety issue: No ]

    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.


  • Medication Attitudes [ Time Frame: Measured at Month 5 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2006
Study Completion Date: July 2010
Primary Completion Date: July 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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: K23 MH074860, K23MH074860, DSIR 8K-RT
Study First Received: July 21, 2006
Results First Received: February 24, 2014
Last Updated: April 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
Dysthymia
Major Depression
Hispanics
Latinos
Motivational Interviewing
Adherence

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

ClinicalTrials.gov processed this record on November 24, 2014