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Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

Improving the Effectiveness of Treatment for Depression in Hispanics

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00742573
Enrollment
170
Registered
2008-08-27
Start date
2008-08-31
Completion date
2014-01-10
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, Mood Disorders, Hispanic

Brief summary

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.

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.

Interventions

DRUGAntidepressants 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.

BEHAVIORALBrief Interpersonal Psychotherapy (IPT-B)

IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Time of Retention52 weeksAverage number of weeks of retention of Hispanics in the treatment of MDD
Hamilton Depression Scale (HAMD-17)BaselineHamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression Minimum is 0 and the maximum score being 52

Countries

United States

Participant flow

Participants by arm

ArmCount
1 Texas Medication Algorithm
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression 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.
83
2 Patient Choice
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression 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. Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
87
Total170

Baseline characteristics

Characteristic2 Patient Choice1 Texas Medication AlgorithmTotal
Age, Categorical
<=18 years
0 Participants2 Participants2 Participants
Age, Categorical
>=65 years
2 Participants2 Participants4 Participants
Age, Categorical
Between 18 and 65 years
85 Participants79 Participants164 Participants
Age, Continuous40.8 years
STANDARD_DEVIATION 11.2
38.2 years
STANDARD_DEVIATION 12.5
39.5 years
STANDARD_DEVIATION 11.9
Region of Enrollment
United States
87 participants83 participants170 participants
Sex: Female, Male
Female
49 Participants48 Participants97 Participants
Sex: Female, Male
Male
38 Participants35 Participants73 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 830 / 87
other
Total, other adverse events
0 / 830 / 87
serious
Total, serious adverse events
0 / 830 / 87

Outcome results

Primary

Hamilton Depression Scale (HAMD-17)

Hamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression Minimum is 0 and the maximum score being 52

Time frame: Baseline

Population: Adult Hispanics with MDD and Non-missing HAMD Total Score

ArmMeasureValue (MEAN)Dispersion
1 Texas Medication AlgorithmHamilton Depression Scale (HAMD-17)23.89 score on a scaleStandard Deviation 3.96
2 Patient ChoiceHamilton Depression Scale (HAMD-17)22.42 score on a scaleStandard Deviation 3.64
Primary

Mean Time of Retention

Average number of weeks of retention of Hispanics in the treatment of MDD

Time frame: 52 weeks

Population: Adult Hispanics with MDD

ArmMeasureValue (MEAN)Dispersion
1 Texas Medication AlgorithmMean Time of Retention27.08 weeksStandard Deviation 22.4
2 Patient ChoiceMean Time of Retention25.84 weeksStandard Deviation 20.54

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026