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

July 21, 2006
April 10, 2014
April 2006
July 2010   (final data collection date for primary outcome measure)
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.
Medication adherence, as measured by electronic pill container (measured immediately post-treatment and at Months 2 and 5 follow-ups)
Complete list of historical versions of study NCT00356304 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Treatment retention
  • Depression
  • Medication attitudes
  • Treatment insight (all measured immediately post-treatment and at Months 2 and 5 follow-ups)
Not Provided
Not Provided
 
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • 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.
  • Behavioral: Treatment as usual
    Participants will continue with their normal treatment regimen as usual.
  • Experimental: 1
    Participants will receive motivational interviewing in addition to their antidepressant therapy
    Intervention: Behavioral: Motivational interviewing
  • Active Comparator: 2
    Participants will receive treatment as usual
    Intervention: Behavioral: Treatment as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00356304
K23 MH074860, K23MH074860, DSIR 8K-RT
No
Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH)
University of Medicine and Dentistry of New Jersey
National Institute of Mental Health (NIMH)
Principal Investigator: Alejandro Interian, PhD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP