Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00742573
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 170
• Location: 1
• Arms: 2
• Duration (Months): 65.3
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving the Effectiveness of Treatment for Depression in Hispanics
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jan 10, 2014
• Actual Study Completion Date: Jan 10, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Mean Time of Retention [52 weeks]

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

2. Hamilton Depression Scale (HAMD-17) [Baseline]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Carlos Blanco, MD, PhD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Olfson, Research Scientist, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00742573
• Other Study ID Numbers: #5692; R01MH076051; DSIR 83-ATSO
• First Posted: Aug 27, 2008
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mark Olfson, Research Scientist, New York State Psychiatric Institute: Major Depressive Disorder; Mood Disorders; Hispanic
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Antidepressive Agents; Bupropion

Study Results

Participant Flow

Arm/Group Title	1 Texas Medication Algorithm	2 Patient Choice
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	83	87
Week 12	46	51
Week 24	39	37
Week 52	26	25
COMPLETED	26	25
NOT COMPLETED	57	62

Baseline Characteristics

Arm/Group Title	1 Texas Medication Algorithm	2 Patient Choice	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	83	87	170
Age (Count of Participants)
<=18 years	2 2.4%	0 0%	2 1.2%
Between 18 and 65 years	79 95.2%	85 97.7%	164 96.5%
>=65 years	2 2.4%	2 2.3%	4 2.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.2 (12.5)	40.8 (11.2)	39.5 (11.9)
Sex: Female, Male (Count of Participants)
Female	48 57.8%	49 56.3%	97 57.1%
Male	35 42.2%	38 43.7%	73 42.9%
Region of Enrollment (participants) [Number]
United States	83 100%	87 100%	170 100%

Outcome Measures

1. Primary Outcome

Title	Mean Time of Retention
Description	Average number of weeks of retention of Hispanics in the treatment of MDD
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Adult Hispanics with MDD

Arm/Group Title	1 Texas Medication Algorithm	2 Patient Choice
Arm/Group Description	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.	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.
Measure Participants	83	87
Mean (Standard Deviation) [weeks]	27.08 (22.4)	25.84 (20.54)

2. Primary Outcome

Title	Hamilton Depression Scale (HAMD-17)
Description	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

Outcome Measure Data

Analysis Population Description

Adult Hispanics with MDD and Non-missing HAMD Total Score

Arm/Group Title	1 Texas Medication Algorithm	2 Patient Choice
Arm/Group Description	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.	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.
Measure Participants	37	38
Mean (Standard Deviation) [score on a scale]	23.89 (3.96)	22.42 (3.64)

Adverse Events

Time Frame	52 weeks
Arm/Group Title	1 Texas Medication Algorithm		2 Patient Choice
Arm/Group Description	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.		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.
All Cause Mortality
	1 Texas Medication Algorithm		2 Patient Choice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/87 (0%)
Serious Adverse Events
	1 Texas Medication Algorithm		2 Patient Choice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	1 Texas Medication Algorithm		2 Patient Choice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/87 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.