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Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
This study is currently recruiting participants.
Study NCT00742573   Information provided by National Institute of Mental Health (NIMH)
First Received: August 25, 2008   Last Updated: March 30, 2009   History of Changes

August 25, 2008
March 30, 2009
August 2008
January 2013   (final data collection date for primary outcome measure)
  • Retention in evidence-based treatment [ Time Frame: Measured at 3 months and 1 year ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale (HAMD-17) [ Time Frame: Measured at baseline and at Weeks -1, 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00742573 on ClinicalTrials.gov Archive Site
  • Treatment Adherence and Retention Questionnaire (TARQ) [ Time Frame: Measured at Weeks -1,12, 24, and 52 ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Perceived Need for Care Questionnaire (PNCQ) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Treatment Adherence and Retention Questionnaire (TARQ) [ Time Frame: Measured at screening and at Weeks 12, 24, 52 ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 ] [ Designated as safety issue: No ]
  • Perceived Need for Care Questionnaire (PNCQ) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 ] [ Designated as safety issue: No ]
 
Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
Improving the Effectiveness of Treatment for Depression in Hispanics

This study will determine whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder.

Major depressive disorder (MDD) prevents an individual from functioning normally, with symptoms like irritability, fatigue, and inability to feel pleasure interfering with school, work, and family life. Treating this disorder in Hispanics is particularly difficult, because they drop treatment two to three times more frequently than European Americans. Evidence suggests that depressed Hispanics prefer treatment of psychotherapy or combined psychotherapy and medication to treatment of medications alone. This study will determine whether offering depressed Hispanics a choice in their treatment option is more effective and results in a higher treatment retention than does prescribing treatment by medication only.

All participants will be randomly assigned to one of two groups for treating their depression. The first group will act as a control group, in which participants will receive 12 weeks of acute medication treatment for MDD according to the Texas Medication Algorithm (TMA). They may receive one of several anti-depressant medications according to this algorithm, including citalopram, escitalopram, paroxetine, sertraline, and others. Each participant in the second group will receive 12 weekly sessions of brief interpersonal psychotherapy (IPT-B), with the option of adding TMA-scheduled medication at any time, as part of a treatment derived in consultation with his or her therapist. Timing of study visits will also be flexible, as participants will be encouraged to continue with MDD treatments. All participants will continue to be examined for 9 months after receiving treatment for this study to determine whether they have continued in MDD treatment. Study visits, where measurements will be taken, will be at screening; at baseline; and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52. All participants will be assessed through clinical interviews and self-report measures for depression symptoms, adherence to treatment, cultural orientation, discrimination and stigma related to treatment, and satisfaction with treatment.

Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Major Depressive Disorder
  • Drug: Antidepressants through Texas Medication Algorithm (TMA)
  • Behavioral: Brief Interpersonal Psychotherapy (IPT-B)
  • Active Comparator: Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
  • Experimental: Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
170
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hispanic
  • DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (Hamilton Depression Score greater than 18)

Exclusion Criteria:

  • At risk of attempting suicide
  • Unstable medical illness
  • History of bipolar disorder, schizophrenia, or other psychotic disorder
  • Pregnant or lactating
  • Alcohol or substance use disorder that requires acute detoxification
Both
18 Years to 65 Years
No
Contact: Carlos Blanco, MD, PhD 212-543-6533 cb255@columbia.edu
Contact: Donna Vermes, RN 212-543-6534 donna@nyspi.cpmc.columbia.edu
United States
 
NCT00742573
Carlos Blanco, New York State Psychiatric Institute
R01 MH076051, DSIR 83-ATSO
National Institute of Mental Health (NIMH)
 
Principal Investigator: Carlos Blanco, MD, PhD New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP