Programa Esperanza (Project Hope): A Depression Program for Older Latinos With Chronic Medical Conditions

April 23, 2019 updated by: Maria P. Aranda, University of Southern California
The purpose of this study is to determine whether individually-administered Problem Solving Treatment is effective in managing depressive symptomatology in 250 primarily Spanish-speaking Latino patients ≥55 years of age or older with high medical comorbidity. The aim is to test if Programa Esperanza improves: a) problem solving skills and behavior activation; b) depression-related outcomes; and b) physical functioning compared to enhanced usual care over the course of one year.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim is to test the comparative effectiveness of Programa Esperanza (Project Hope) a short-term culturally-modified psychosocial intervention for primarily Spanish-speaking Latino patients 55 years of age or older with depression and multiple medical conditions-compared to Enhanced Usual Care (EUC), the alternative choice in real-world care. The study will address the following questions:

Primary Research Question: Among 250 low-income, primarily Spanish-speaking Latinos ≥55 years of age with high medical comorbidity, will Programa Esperanza improve: a) problem solving skills and behavior activation; b) depression-related outcomes; and b) physical functioning compared to EUC over the course of one year?

Exploratory Research Questions:

  1. Do moderating conditions exist such that the intervention may be more or less effective for some patient subgroups compared to others?
  2. Will qualitative reports from our patient population and provider stakeholders provide key insights related to treatment effectiveness, acceptance and satisfaction, as well as adoption of the intervention within the patient-centered medical home (PCMH) setting?
  3. Among patients, interventionists, and organization leaders, are there high feasibility, fidelity, and acceptability of training and deployment of nontraditional interventionists to deliver the psychosocial treatment within the PCMH setting?

Randomized Clinical Trial Design. The study will enroll 250 limited-English-speaking Latinos (55+ years) from the AltaMed Program of All Inclusive Care for the Elderly (PACE), a geriatric patient-centered medical home model in Los Angeles County. Subjects who meet PHQ-9 criteria for depression (i.e., score of 8 or greater) will be randomized to one of two study arms: either individually administered Problem Solving Treatment (PST) sessions (n=125) facilitated by bachelor's-level social workers under the supervision of a licensed clinical social worker; or EUC. Data collected at study enrollment will document past and baseline patient characteristics including baseline depression and depression severity scores. Assessment of depression trial outcomes, i.e., depression symptom level (PHQ-9); depression response and remission rates, and will be taken at 3, 6 and 12 months post randomization.

Study Site. AltaMed is a nonprofit, federally-qualified health center and one of the oldest and largest providers of senior care services for older racial/ethnic minorities in the US for over 30 years. The sample will be recruited from enrollees across 8 licensed PACE treatment sites. PACE is an optional, capitated CMS managed care benefit that provides comprehensive medical and social services to frail people who disproportionately rely on Medicaid/Medicare services. Typical of other PACE programs, AltaMed offers a PCMH comprised of intensive health, therapeutic, and social services for adults at risk of nursing home institutionalization.

Study Subjects/ Selection Criteria/ Recruitment and Enrollment. A total of 250 subjects who meet PHQ-9 criteria for depression (> 8 PHQ-9 score) will be selected for this randomized trial. for detecting major depressive disorder for cut-off scores as low as 8. Potential subjects will be selected from the pool of PACE enrollees and identified by AltaMed staff based on routine PHQ-9 screening conducted face-to-face or by telephone. Those who score positive for depression (> 8 PHQ-9 score) will be recruited and consented to participate in the study by either designated AltaMed staff or study research personnel. Inclusion criteria include: English- or Spanish-speaking Latino age 55 years or older; receiving services from any AltaMed PACE site; positive for depression (> 8 PHQ-9 score). In anticipation of attrition, the investigators will over-recruit subjects at enrollment by 10%.

Procedures. Following screening of PACE enrollees by AltaMed staff, PACE study consenters will apprise potential subjects meeting study criteria of the study protocol and their eligibility and will be responsible for the initial consent procedures. Upon documented written consent, research personnel will conduct a face-to-face structured baseline interview as well as review any questions the participant may have regarding informed consent and the study. Randomization will be conducted at the level of the individual subject. Between 1 to 7 days after the baseline interview, the study program coordinator will contact subjects and apprise them of their treatment status in the study.

Comparators. Problem Solving Treatment. Individual, face-to-face PST sessions (as described above) over a span of 8 weeks will be held at PACE sites. The first session will last one hour while subsequent sessions will last 45 minutes. After the last PST session, each subject will have 3 monthly booster sessions (about 15 minutes). The PST protocol is intended to be highly structured, time-limited, and manual-driven; sessions include PST hand outs and homework as well as social and behavioral activation strategies, i.e., pleasant activities scheduling.

Enhanced Usual Care. EUC patients will receive psychoeducational materials on depression and depression treatment of older persons. The materials are based on our prior work and are available in Spanish and English. EUC patients will continue to receive the full complement of PACE services (medical, rehabilitation, social) including referrals to specialty mental health services, if indicated.

Data Collection. Consented patients will receive a 60 minute face-to-face baseline interview before randomization to be conducted by study personnel. Outcome interviews (60 minutes) will be conducted in-person by independent study interviewers. Data will be based on multiple sources: self-report and clinician-rendered diagnoses, anthropometric measures, medical records and claims data extraction.

Qualitative study design and procedures. In order to address our secondary research questions the investigators will conduct in-depth and focus group interviews with our respective stakeholders.

Patients: During the three post baseline assessment (and after the 3-month quantitative data collection) the investigators will conduct an open-ended component to assess more in-depth explorations of the treatment experience, and longer term issues that may emerge with PST or EUC. This component will be administered based on a guide/questioning route designed to collect in-depth information on the feasibility and acceptability of the intervention based on the subject's own perceptions and reactions to treatment. Dropouts as well as completers will be included. Providers (interventionists, AltaMed managers and executive leadership): The investigators will query providers based on a focus group approach: 2 separate groups of 10 persons each.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
259

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English or Spanish-speaking Latino age 55 years or older
  • receiving services from any AltaMed PACE site
  • positive for depression (> 8 PHQ-9 score)

Exclusion Criteria:

  • current drinking problems
  • disorders with active mania or psychotic symptoms
  • cognitive impairment precluding ability to give informed consent or participating in the intervention
  • an active medical condition with life expectancy less than 6 months
  • anticipated absences or disenrollment from PACE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Problem Solving Treatment
Problem Solving Treatment Individual, face-to-face PST sessions over a span of 8 weeks and 3 monthly booster sessions. The PST protocol is highly structured, time-limited, and manual-driven; sessions include PST hand outs and homework as well as social and behavioral activation strategies.
Behavioral: Problem Solving Treatment
Individual, face-to-face PST sessions over a span of 8 weeks will be held at PACE sites. The first session will last one hour while subsequent sessions will last 45 minutes. After the last PST session, each subject will have 3 monthly booster sessions (about 15 minutes). The PST protocol is intended to be highly structured, time-limited, and manual-driven; sessions include PST hand outs and homework as well as social and behavioral activation strategies, i.e., pleasant activities scheduling. All interventionists will document attendance and provide a post-session fidelity summary. 10% of the individual sessions will be videotaped with patient consent to assess fidelity and training needs.
Other Names:
  • PST
Active Comparator: Enhanced Usual Care
Enhanced Usual Care EUC patients will receive psychoeducational materials on depression and depression treatment of older persons. EUC patients will continue to receive the full complement of PACE services (medical, rehabilitation, social) including referrals to specialty mental health services, if indicated.
Behavioral: Enhanced Usual Care
EUC patients will receive psychoeducational materials on depression and depression treatment of older persons. EUC patients will continue to receive the full complement of PACE services (medical, rehabilitation, social) including referrals to specialty mental health services, if indicated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PHQ-9
Time Frame: 3-, 6-, and 12 months
change from initial screening - depressive symptomatology
3-, 6-, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SCL-20
Time Frame: 3-, 6-, and 12 months
change from baseline - depressive symptomatology
3-, 6-, and 12 months
Social Problem-Solving Inventory-Revised
Time Frame: 3-, 6-, and 12 months
change from baseline - social problem solving skills
3-, 6-, and 12 months
PEARLS-Behavioral Activation
Time Frame: 3-, 6-, and 12 months
change from baseline - behavioral activation
3-, 6-, and 12 months
Sheehan Disability Scale
Time Frame: 3-, 6-, and 12 months
change from baseline - disability level
3-, 6-, and 12 months
Performance Oriented Mobility Assessments
Time Frame: 3-, 6-, and 12 months
change from baseline - physical functioning
3-, 6-, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria P Aranda, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AD-1403-13904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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