Clinical trial NCT00356304: Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Official title: Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Dysthymia
Major Depression
Hispanics
Latinos
Motivational Interviewing
Adherence
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Medication Adherence, as Measured by Electronic Pill Container
timeFrame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups
Secondary outcomes:
measure: Treatment Retention
timeFrame: Measured at Month 5
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Measured at Month 5
measure: Medication Attitudes
timeFrame: Measured at Month 5
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: University Behavioral Healthcare
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Alejandro Interian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. doi: 10.1176/ps.2007.58.12.1591.
citation: Escobar JI, Cook B, Chen CN, Gara MA, Alegria M, Interian A, Diaz E. Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. J Psychosom Res. 2010 Jul;69(1):1-8. doi: 10.1016/j.jpsychores.2010.01.001. Epub 2010 Feb 16.
citation: Interian A, Lewis-Fernandez R, Gara MA, Escobar JI. A randomized-controlled trial of an intervention to improve antidepressant adherence among Latinos with depression. Depress Anxiety. 2013 Jul;30(7):688-96. doi: 10.1002/da.22052. Epub 2013 Jan 8.