Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

• ClinicalTrials.gov Identifier: NCT00356304
• Recruitment Status: Completed
• First Posted: July 25, 2006
• Results First Posted: May 8, 2014
• Last Update Posted: May 8, 2014
• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH)

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: Motivational interviewing; Behavioral: Treatment as usual	Phase 1

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 (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
• Study Start Date: April 2006
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Treatment Retention [ Time Frame: Measured at Month 5 ]
2. Beck Depression Inventory-II (BDI-II) [ Time Frame: Measured at Month 5 ]

   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.

3. Medication Attitudes [ Time Frame: Measured at Month 5 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Alejandro Interian, PhD; Rutgers, The State University of New Jersey

More Information

Publications of Results:

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.

Other Publications:

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.

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.

• Responsible Party: Alejandro Interian, Ph.D., Adjunct Assistant Professor, National Institute of Mental Health (NIMH)
• ClinicalTrials.gov Identifier: NCT00356304
• Other Study ID Numbers: K23MH074860 ( U.S. NIH Grant/Contract ); K23MH074860 ( U.S. NIH Grant/Contract ); DSIR 8K-RT
• First Posted: July 25, 2006
• Results First Posted: May 8, 2014
• Last Update Posted: May 8, 2014
• Last Verified: April 2014

Keywords provided by Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH):

Dysthymia; Major Depression; Hispanics; Latinos; Motivational Interviewing; Adherence

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders