Digital Health Program for Post-COVID Syndrome

(LIGHT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Limited mental capacity, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital health program called iENDURE, designed to help people with Long COVID manage stress and improve motivation. Participants will use this technology-driven program for four weeks and share their experiences afterward. It suits those who have had COVID-19 and continue to experience symptoms affecting daily life. Participants must speak English, use a device that can send texts, and be willing to share their experiences through assessments and interviews. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those with Long COVID.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the iENDURE intervention is safe for participants with Long COVID?

Research has shown that many people with COVID-19 continue to experience symptoms long after the initial infection, a condition often called Long COVID. The iENDURE treatment is a digital health program designed to help people with Long COVID by teaching skills to manage stress and boost motivation.

Regarding safety, the iENDURE program is neither a medication nor a medical procedure. As a skills training program delivered through technology, it carries a lower risk of physical side effects compared to drugs. Although specific data from other studies about safety issues with iENDURE itself is not available, its focus on teaching skills suggests it should be well-tolerated by participants. Always consult a healthcare provider for advice tailored to individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional treatments for post-COVID syndrome that often focus on medication or physical therapy, iENDURE is unique because it delivers distress tolerance skills training through digital technology. This approach empowers individuals by providing them with tools to manage emotional distress, potentially leading to better mental health outcomes. Researchers are excited about iENDURE because it offers a non-pharmacological option that can be accessed remotely, making it more convenient and accessible for people still grappling with the long-term effects of COVID-19.

What evidence suggests that the iENDURE program is effective for Long COVID?

Research shows that digital programs can help people with post-COVID or long-COVID symptoms. Studies indicate that online rehabilitation programs, offering both physical and mental health support, can improve participants' quality of life. One trial found that supervised online programs effectively manage these symptoms. Another study highlighted the benefits of short, outpatient cognitive and behavioral programs. These findings suggest that digital programs like iENDURE, which participants in this trial will use to learn skills for handling distress, may effectively manage long-COVID symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Kirsten Langdon, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have self-reported Long COVID symptoms and a past diagnosis of COVID-19. Participants must own a device capable of texting and speak English well enough to give informed consent.

Inclusion Criteria

Must own a text-enabled device

I have symptoms of Long-COVID.

I have been diagnosed with COVID-19.

Exclusion Criteria

I am not fluent in English.

I am unable to understand or sign the consent form due to mental capacity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in the iENDURE intervention for Long COVID symptoms

4 weeks

Weekly virtual sessions

Follow-up

Participants complete a post-intervention assessment and qualitative interview

1 week

What Are the Treatments Tested in This Trial?

Interventions

• iENDURE

Trial Overview The iENDURE program, aimed at improving distress tolerance in individuals with Long COVID, is being tested. It involves a baseline assessment, a 4-week intervention period using digital health technology, followed by another assessment and interview.

How Is the Trial Designed?

Group I: distress tolerance skills training Experimental Treatment 1 Intervention

technology delivered distress tolerance skills training

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131666/

Digital Interventions for Treating Post-COVID or Long-COVID ... We reviewed evidence-based digital interventions that are currently available to help manage physical and mental health in patients with post-COVID/long-COVID ...

2. bmj.com bmj.com/content/384/bmj-2023-076506

Clinical effectiveness of an online supervised group ... An online, home based, supervised, group physical and mental health rehabilitation programme was clinically effective at improving health related quality of ...

3. archpublichealth.biomedcentral.com archpublichealth.biomedcentral.com/articles/10.1186/s13690-024-01354-w

Effectiveness of an online multimodal rehabilitation program in ... This trial assesses the effectiveness of a multimodal rehabilitation program —comprising both online and synchronous components— in managing the ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828267

Brief Outpatient Rehabilitation Program for Post–COVID-19 ... This randomized clinical trial examines the effectiveness of a 2- to 6-week outpatient cognitive and behavioral rehabilitation program for individuals.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11495871/

Digital approaches in post-COVID healthcare: a systematic ... This study aims to map the use of modern digital approaches in estimating the prevalence, predicting, diagnosing, treating, monitoring, and prognosis of PCC.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05375760

Study Details | NCT05375760 | A Randomized, Open-label ... This Phase II dose-ranging study will investigate the safety, immunogenicity, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of AZD7442 repeat dosing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9864843/

Long Covid: Untangling the Complex Syndrome and the ... The WHO estimates that between 10% and 20% of those infected with the SARS-CoV-2 virus could endure persistent symptoms long after the acute infection has ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1453167/full

Consensus based recommendations for the management ... Many patients with COVID-19 recover within a few days to weeks; however, symptoms may persist weeks to months in some patients, severely affecting the quality ...

9. patientsafetylearning.org patientsafetylearning.org/blog/patient-safety-concerns-for-long-covid-patients

Patient safety concerns for Long COVID patients Establish a scientific approach to the study of patients undergoing prolonged COVID-19 symptoms (ensuring the cohort that was not hospitalised ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1684118222001864

Long COVID: An inevitable sequela of SARS-CoV-2 infection Another meta-analysis involving 15,244 hospitalized and 9011 non-hospitalized patients reported that 63.2 and 71.9% of patients had ≥1 post-COVID-19 symptom at ...