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

NCT02459860 | Completed DMC

• 1 other identifier: AD-1403-13904
• Study Type: interventional
• Target: 259
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression

Keywords

depression; randomized behavioral trial; aged; Latinos; Spanish-speaking; chronic medical conditions

Outcome Measures

Primary Outcomes (1)

• PHQ-9

  change from initial screening - depressive symptomatology

  3-, 6-, and 12 months

Secondary Outcomes (5)

• SCL-20

  3-, 6-, and 12 months

• Social Problem-Solving Inventory-Revised

  3-, 6-, and 12 months

• PEARLS-Behavioral Activation

  3-, 6-, and 12 months

• Sheehan Disability Scale

  3-, 6-, and 12 months

• Performance Oriented Mobility Assessments

  3-, 6-, and 12 months

Study Arms (2)

Problem Solving Treatment

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Problem Solving Treatment BEHAVIORAL

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.

Also known as: PST

Problem Solving Treatment

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Maria P Aranda, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 2, 2015
• Study Start: January 1, 2015
• Primary Completion: January 23, 2018
• Study Completion: December 31, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04