HOPE-LC~Español for Long COVID

(HOPE-LC Trial)

Overseen By Amelia Hicks, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Severe psychiatric conditions, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new group therapy program called HOPE-LC~Español, designed to help Spanish-speaking individuals manage Long COVID. The program aims to build resilience and enhance coping skills for those experiencing ongoing emotional or cognitive symptoms that affect daily life. It is ideal for Spanish speakers with Long COVID who can join group sessions either in person or online. The trial will evaluate the feasibility and effectiveness of this approach for participants. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve support for Long COVID patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on group therapy for Long COVID, so it's best to check with the trial organizers for specific guidance.

What prior data suggests that this group therapy model is safe for Spanish-speaking individuals with Long COVID?

Research has shown that the HOPE-LC~Español program helps people with Long COVID build resilience and coping skills. This program uses group therapy, not medication or surgery, so it generally poses fewer safety concerns than treatments involving drugs.

Although specific safety data for HOPE-LC~Español is not available, group therapy is usually well-received. It includes discussions and activities to enhance mental health and coping strategies. Unlike medications or medical procedures, this type of treatment typically does not cause physical side effects.

For those considering this program, the main benefit is the mental and emotional support it offers, rather than concerns about physical safety or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HOPE-LC~Español because it specifically targets Spanish-speaking patients living with Long COVID, which is a group often underserved by current treatment options. Unlike standard treatments focused primarily on symptom management, this program aims to provide culturally and linguistically tailored support, which could lead to better engagement and outcomes for these patients. By addressing the unique needs of this community, HOPE-LC~Español has the potential to improve quality of life and overall health outcomes more effectively than one-size-fits-all approaches.

What evidence suggests that the HOPE-LC~Español program is effective for Long COVID?

Research has shown that Long COVID, also called PASC (post-acute sequelae of SARS-CoV-2), is a complex condition affecting millions. It can cause symptoms such as tiredness, difficulty breathing, and trouble concentrating. The HOPE-LC~Español program, provided to participants in this trial, aims to help individuals manage these issues by teaching resilience and adaptation skills. Although direct evidence on the effectiveness of this specific therapy is limited, similar group therapy models have shown promise in helping people manage long-term health problems. The goal is for this culturally adapted program to offer meaningful support to Spanish-speaking individuals dealing with Long COVID. ^{1 6 7 8 9}

Who Is on the Research Team?

Eric Watson

Principal Investigator

Icahn School of Medicine

Amelia Hicks, PhD

Principal Investigator

Icahn School of Medicine

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking individuals in Queens who are experiencing chronic Long COVID symptoms. It aims to help them build resilience and coping skills through a group therapy program called HOPE-LC~Español, specifically adapted for their cultural and linguistic needs.

Inclusion Criteria

I speak and understand Spanish well enough to take part in group activities.

I am 18 years old or older.

I can attend group sessions in person or through Zoom.

Exclusion Criteria

Concurrent participation in another conflicting interventional trial targeting Long COVID symptoms

I do not have severe mental health issues that would stop me from joining group therapy.

I cannot speak Spanish well enough for group sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week online group therapy program tailored for Long COVID

12 weeks

Weekly online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HOPE-LC~Espanol

Trial Overview HOPE-LC~Español, a culturally tailored group therapy program for Spanish speakers with Long COVID, is being tested. The study will recruit 25 participants to assess the feasibility of the program and its preliminary effectiveness in fostering optimism and perseverance.

How Is the Trial Designed?

Group I: Patients Living with Chronic Long-COVID Experimental Treatment 1 Intervention

Spanish-speaking patients in the HOPE-LC program.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ... Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11418572/

Long COVID or Post-Acute Sequelae of SARS-CoV-2 Infection ... The study aimed to identify the symptoms present in SARS-CoV-2-infected individuals at six months or more after infection compared with uninfected individuals ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.908757/full

Post-acute Sequelae of SARS-CoV-2 Infection There is an increased long-term risk of cardiovascular complications such as heart failure among patients with SARS-CoV-2 infection, even among mild cases (15).

4. recovercovid.org recovercovid.org/publications/post-acute-sequelae-sars-cov-2-infection-long-covid-older-adults

Post-acute sequelae of SARS-CoV-2 infection (Long ... Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667036424000086

A System-wise Approach on the Effects of Long-Covid-19 PASC can manifest with a wide range of symptoms, including fatigue, dyspnea, cognitive dysfunction, chest pain, headache, muscle aches, joint pain, insomnia, ...

6. researchgate.net researchgate.net/publication/358616961_Post-Acute_Sequelae_of_SARS_CoV-2_infection

Post-Acute Sequelae of SARS CoV-2 infection | Request PDF An estimated 10%e30% of patients experience debilitating symptoms months after resolution of the acute infection [1].

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38874693/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ... Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

8. ccjm.org ccjm.org/content/88/5/267

Post-acute sequelae of SARS-CoV-2 infection: Caring for ... In patients with PASC, symptoms may persist for more than 60 days and as long as 6 months. Focus treatment on managing comorbidities, pulmonary ...

9. gvn.org gvn.org/long-covid-the-impact-of-post-acute-sequelae-of-covid-19-pasc/

The Impact of Post-Acute Sequelae of COVID-19 (PASC) Post-acute sequelae of SARS-CoV-2 (PASC, or “long COVID”) is characterized by persistent symptoms and/or delayed or long-term complications beyond 4 weeks from ...