NCT00356304

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

May 8, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

July 21, 2006

Results QC Date

February 24, 2014

Last Update Submit

April 10, 2014

Conditions

Depression

Keywords

DysthymiaMajor DepressionHispanicsLatinosMotivational InterviewingAdherence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Treatment Retention

    Measured at Month 5

  • Beck Depression Inventory-II (BDI-II)

    Measured at Month 5

  • Medication Attitudes

    Measured at Month 5

Study Arms (2)

1

EXPERIMENTAL

Participants will receive motivational interviewing in addition to their antidepressant therapy

Behavioral: Motivational interviewing

2

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual

Interventions

Motivational interviewingBEHAVIORAL

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.

1
Treatment as usualBEHAVIORAL

Participants will continue with their normal treatment regimen as usual.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Behavioral Healthcare

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (3)

  • 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.

    PMID: 18048562BACKGROUND

  • 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.

    PMID: 20630257BACKGROUND

  • 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.

    PMID: 23300127RESULT

MeSH Terms

Conditions

DepressionDysthymic DisorderDepressive Disorder, Major

Interventions

Motivational InterviewingTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Alejandro Interian, Principal Investigator
Organization
VA New Jersey Healthcare System
alejandro.interian@va.gov
908-647-0180

Study Officials

  • Alejandro Interian, PhD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Assistant Professor

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 25, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 8, 2014

Results First Posted

May 8, 2014

Record last verified: 2014-04

Locations

US(1)