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Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Treatment as usual
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Dysthymia, Major Depression, Hispanics, Latinos, Motivational Interviewing, Adherence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Behavioral Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive motivational interviewing in addition to their antidepressant therapy

Participants will receive treatment as usual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment Retention
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.
Medication Attitudes

Full Information

First Posted
July 21, 2006
Last Updated
April 10, 2014
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00356304
Brief Title
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Official Title
Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Dysthymia, Major Depression, Hispanics, Latinos, Motivational Interviewing, Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive motivational interviewing in addition to their antidepressant therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Participants will continue with their normal treatment regimen as usual.
Primary Outcome Measure Information:
Title
Medication Adherence, as Measured by Electronic Pill Container
Description
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.
Time Frame
Measured immediately post-treatment and at Months 2 and 5 months follow-ups
Secondary Outcome Measure Information:
Title
Treatment Retention
Time Frame
Measured at Month 5
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Measured at Month 5
Title
Medication Attitudes
Time Frame
Measured at Month 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Interian, PhD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Behavioral Healthcare
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18048562
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.
Results Reference
background
PubMed Identifier
20630257
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.
Results Reference
background
PubMed Identifier
23300127
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.
Results Reference
result

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Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

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