Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00742573
First received: August 25, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Antidepressants through Texas Medication Algorithm (TMA)
Behavioral: Brief Interpersonal Psychotherapy (IPT-B)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Effectiveness of Treatment for Depression in Hispanics

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Treatment Adherence and Retention Questionnaire (TARQ) [ Time Frame: Measured at baseline and at Weeks 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 ]

Estimated Enrollment: 170
Study Start Date: August 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Texas Medication Algorithm
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
Drug: Antidepressants through Texas Medication Algorithm (TMA)
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Other Names:
  • Celexa
  • Lexapro
  • Paxil
  • Zoloft
  • Effexor XR
  • Wellbutrin
  • Cymbalta
  • Pamelor
  • Remeron
Experimental: 2 Patient Choice
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
Drug: Antidepressants through Texas Medication Algorithm (TMA)
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Other Names:
  • Celexa
  • Lexapro
  • Paxil
  • Zoloft
  • Effexor XR
  • Wellbutrin
  • Cymbalta
  • Pamelor
  • Remeron
Behavioral: Brief Interpersonal Psychotherapy (IPT-B)
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.

Detailed Description:

Retention of Hispanics in the treatment of major depressive disorder (MDD) continues to be a major public health problem. Hispanics drop out from treatment two to three times more frequently than non-Hispanic whites, despite the scarcity of treatment alternatives for Hispanics and their low rates of re-entry into the mental health care system. Consistent with the goals of Healthy People 2010 and the President's New Freedom Commission on Mental Health, the goal of this study is to test the efficacy in a research setting of a novel intervention to improve retention and response. This efficacy assessment would serve as a reference point for the development of future effectiveness trials in community settings.

Our intervention is founded on growing evidence that when depressed Hispanics seek help for mental health problems, they prefer to receive psychotherapy or combined treatment in the form of weekly in-person clinic visits. However, socioeconomic barriers, such as low-paying jobs with irregular hours, lack of child care, and limited time availability, often reduce treatment retention and result in dropout rates up to three times those of non-Hispanic whites. Based on emerging literature and on promising pilot data, we propose to study the efficacy for depressed Hispanics of an intervention that would allow for patient choice between the following options: 1) Medication alone, following the Texas Medication Algorithm for Depression (TMA); 2) Brief Interpersonal Psychotherapy (IPT-B) alone, with optional telephone sessions; or 3) Combined medication plus IPT-B. This intervention would allow switching of treatment modality (e.g., from IPT-B alone to combined treatment) at any point during the study period. We hypothesize that by permitting patient choice among evidence-based treatments, flexibility in the sequential use of treatments, and novel treatment delivery systems, this intervention will substantially increase retention of Hispanics in MDD treatment. Furthermore, we will examine mediators and moderators of retention, including stigma and insurance coverage.

We propose to test this intervention in depressed Hispanics seeking outpatient psychiatric treatment using a randomized trial with TMA as the control group. Both groups will have access to medication using the TMA but only one group will be offered IPT_B. . We will test the association between treatment, retention, and response over the course of acute MDD care (12 weeks), and will also obtain preliminary outcome data after 9 more months of treatment (i.e., for a total of 12 months). Our pilot data enable us to estimate the sample size for the acute phase, while the additional follow-up period allows us to examine the effect of choice over the longer-term course of MDD care.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hispanic males and females
  • DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17> 18)
  • 18- 79
  • Patients with stable dosage of Benzodiazepines to treat anxiety disorders

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742573

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Carlos Blanco, MD, PhD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00742573     History of Changes
Other Study ID Numbers: #5692, R01MH076051, DSIR 83-ATSO
Study First Received: August 25, 2008
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Major Depressive Disorder
Mood Disorders
Hispanic

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014