Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

Depression Clinical Trial

Official title:

Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356304
• Other study ID #: K23MH074860
• Secondary ID: K23MH074860DSIR
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2006
• Last updated: April 10, 2014
• Start date: April 2006
• Est. completion date: July 2010

Study information

• Verified date: April 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• Treatment as usual
Participants will continue with their normal treatment regimen as usual.

Locations

Country	Name	City	State
United States	University Behavioral Healthcare	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Escobar JI, Cook B, Chen CN, Gara MA, Alegría 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. — View Citation

Interian A, Lewis-Fernández 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence, as Measured by Electronic Pill Container	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.	Measured immediately post-treatment and at Months 2 and 5 months follow-ups	No
Secondary	Treatment Retention		Measured at Month 5	No
Secondary	Beck Depression Inventory-II (BDI-II)	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.	Measured at Month 5	No
Secondary	Medication Attitudes		Measured at Month 5	No