What is the mechanism of action of this treatment?

Problem-solving therapy (PST) and cognitive-behavioral therapy (CBT) are common treatments for depression that work by enhancing problem-solving skills and self-efficacy. PST helps patients identify and solve problems contributing to their depression, reducing feelings of helplessness and improving mood. CBT focuses on changing negative thought patterns and behaviors that perpetuate depression. These therapies are important for depression patients as they provide practical tools to manage symptoms, improve daily functioning, and reduce the overall burden of depression.

What side effects are associated with this type of intervention?

Common treatments for depression include antidepressants and psychotherapies. Antidepressants like SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., duloxetine) can cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. Tricyclic antidepressants (TCAs) may lead to dry mouth, blurred vision, constipation, and urinary retention. Psychotherapies, including Cognitive Behavioral Therapy (CBT) and problem-solving interventions, generally have fewer physical side effects but may cause emotional discomfort as patients confront challenging issues. Overall, the side effects vary depending on the specific treatment and individual patient response.

What prior FDA approvals exist?

The FDA has approved several classes of antidepressants for the treatment of depression, including SSRIs (e.g., escitalopram, fluoxetine), SNRIs (e.g., duloxetine, venlafaxine), and tricyclic antidepressants (e.g., imipramine). These medications have been shown to be effective in reducing depressive symptoms. Additionally, psychotherapeutic interventions such as problem-solving therapy have been studied and found to be effective in reducing depression and improving functional outcomes. Problem-solving therapy focuses on enhancing problem-solving skills and self-efficacy, which can help reduce caregiver burden and depression.

What other types of research exist?

Promising, novel alternatives to Problem-Solving Intervention for depression patients include Cognitive Behavioral Therapy (CBT), which has shown efficacy in reducing symptoms of depression and improving functioning. Technology-enhanced delivery of CBT, such as online modules and smartphone applications, offers accessible and flexible treatment options. Additionally, the Early Start Denver Model (ESDM), which combines intensive ABA programming with developmental and relationship-based approaches, has demonstrated long-term improvements in cognitive and adaptive functioning, though primarily in young children with ASD, it suggests potential for broader applications. Family therapy and behavioral family counseling are also effective in reducing caregiver burden and improving patient outcomes.

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Problem-Solving Intervention for Stroke Caregivers (RESCUE Espanol Trial)

N/A

Waitlist Available

Led By Ivette Magaly Freytes, PhD MEd BA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9 weeks, and 20 weeks

Awards & highlights

Summary

This trial tests a problem-solving program for Spanish-speaking caregivers of stroke-affected Veterans. The program, accessible via phone and online, aims to reduce stress and improve problem-solving skills by providing guided support.

Who is the study for?

This trial is for Hispanic caregivers who primarily speak Spanish and are the main caregiver for a Veteran with stroke diagnosed within the last year, having significant daily activity challenges or worsening neurological issues. They must have moderate to severe stress, internet access, phone availability, and agree to be randomly assigned to either the intervention or standard care group.

What is being tested?

The study tests a culturally-tailored problem-solving intervention delivered by phone and online aimed at reducing caregiver burden and depression while improving their problem-solving skills, self-efficacy, quality of life, as well as the functional abilities of Veterans they care for.

What are the potential side effects?

Since this is a non-medical intervention focusing on problem-solving skills via telephone and online resources, traditional physical side effects associated with medications are not expected. However, participants may experience emotional discomfort discussing personal issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 weeks, and 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 weeks, and 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 weeks, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Caregiver Depression

Secondary study objectives

Change in Caregiver Burden

Change in Caregiver Health Related Quality of Life

Change in Caregiver Problem Solving Abilities

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Problem Solving InterventionExperimental Treatment1 Intervention

The intervention consists of a problem-solving intervention and information/tools on the previously developed, evidenced-based Spanish-version of the RESCUE stroke caregiver website to improve stroke caregiver outcomes. The intervention will be conducted via telephone by a trained rehabilitation counselor. The intervention consists of four components: 1. Introduction to the RESCUE website and the problem-solving method; 2. Illustrative example on how to use the problem-solving approach and the RESCUE website to address caregiving problems; 3. Individualized practice exercise to develop a personalized problem-solving plan; and 4. Summary of the problem-solving method.

Group II: Standard CareActive Control1 Intervention

Study participants will receive the usual standard care they would receive had they not been enrolled in this study

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Problem-solving therapy (PST) and cognitive-behavioral therapy (CBT) are common treatments for depression that work by enhancing problem-solving skills and self-efficacy. PST helps patients identify and solve problems contributing to their depression, reducing feelings of helplessness and improving mood. CBT focuses on changing negative thought patterns and behaviors that perpetuate depression. These therapies are important for depression patients as they provide practical tools to manage symptoms, improve daily functioning, and reduce the overall burden of depression.

Problem-solving training as an active ingredient of treatment for youth depression: a scoping review and exploratory meta-analysis.The effectiveness of nonpharmacological interventions in older adults with depressive disorders: a systematic review.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,647 Previous Clinical Trials

3,359,843 Total Patients Enrolled

78 Trials studying Depression

19,717 Patients Enrolled for Depression

Ivette Magaly Freytes, PhD MEd BAPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL

Media Library

RESCUE Problem Solving Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03142841 — N/A

Depression Research Study Groups: Standard Care, Problem Solving Intervention

Depression Clinical Trial 2023: RESCUE Problem Solving Intervention Highlights & Side Effects. Trial Name: NCT03142841 — N/A

RESCUE Problem Solving Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03142841 — N/A

~30 spots leftby Sep 2025

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