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Clinical Trials/NCT00356304
NCT00356304CompletedPhase 1

Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach

University of Medicine and Dentistry of New Jersey1 site in 1 country50 target enrollmentStarted: April 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Medication Adherence, as Measured by Electronic Pill Container

Study Overview

Brief Summary

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

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Participants will receive motivational interviewing in addition to their antidepressant therapy

Intervention: Motivational interviewing (Behavioral)

2

Active Comparator

Participants will receive treatment as usual

Intervention: Treatment as usual (Behavioral)

Outcomes

Primary Outcomes

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

  • Treatment Retention(Measured at Month 5)
  • Beck Depression Inventory-II (BDI-II)(Measured at Month 5)
  • Medication Attitudes(Measured at Month 5)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alejandro Interian, Ph.D.

Adjunct Assistant Professor

National Institute of Mental Health (NIMH)

Study Sites (1)

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