What side effects are associated with this type of intervention?

Psychotherapeutic interventions for Long COVID, such as those used in the Long COVID Coping and Recovery (LCCR) program, generally aim to improve psychological adjustment, promote resilience, and facilitate coping. Common side effects of psychotherapeutic treatments can include emotional discomfort during sessions, temporary increases in anxiety or distress, and fatigue. These side effects are typically mild and transient, and the benefits of improved mental health and coping skills often outweigh these temporary discomforts.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, primarily focusing on antiviral medications like remdesivir and monoclonal antibodies. However, psychotherapeutic interventions such as those studied in the Long COVID Coping and Recovery (LCCR) trial, which aim to improve psychological adjustment, promote resilience, and facilitate coping, are not typically within the scope of FDA approvals for COVID-19. These interventions are more aligned with behavioral health strategies and are often implemented as part of comprehensive care plans rather than standalone FDA-approved treatments.

What other types of research exist?

Promising alternatives to Long COVID Coping and Recovery (LCCR) include: 1) Telehealth-based psychiatric interventions, which have been rapidly implemented and show potential for improving mental health outcomes. 2) Smartphone app-based interventions for managing post-traumatic stress disorder (PTSD) in COVID-19 convalescent patients, which are being systematically reviewed and may offer accessible support. 3) Complementary and Alternative Medicine (CAM) interventions, though more research is needed to establish their efficacy. 4) Rehabilitation programs focusing on fatigue, breathlessness, exercise capacity, and cognition, which have shown feasibility and significant clinical improvements.

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Psychotherapy for Long COVID

Q: What is the mechanism of action of this treatment?

Common treatments for COVID-19 include antiviral agents, steroids, and immunomodulators, which work by reducing viral replication, inflammation, and modulating the immune response. Non-pharmacologic treatments, such as those studied in the Long COVID Coping and Recovery (LCCR) trial, focus on psychotherapeutic interventions aimed at improving psychological adjustment, promoting resilience, and facilitating coping. These interventions are crucial for managing long-term effects like anxiety, depression, and stress-related disorders, addressing both physical and mental health challenges to improve overall patient outcomes.

N/A

Waitlist Available

Led By Marianne S. Goodman, MD

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

Ages 18-80

Be older than 18 years old

Must not have

Lack of capacity to consent

MINI Mental Status < 23 or inability to function in a group setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this outcome will be measured at 2 time points: consent & baseline and immediately post intervention (after the second 8 sessions)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a therapy program called Long COVID Coping and Recovery (LCCR) for Veterans with Long COVID. The program aims to help them manage their symptoms and improve mental health through group sessions that teach coping skills and build resilience. The goal is to see if the program is feasible and beneficial for Veterans.

Who is the study for?

This trial is for U.S. Veterans aged 18-80 with Long COVID, who are clinically stable to join group therapy and use VA services at the JJPVAMC. Participants must have had a positive COVID-19 test and symptoms lasting over a month. Those with severe mental impairment, inability to engage in groups, or active substance dependence can't join.

What is being tested?

The LCCR Intervention is being tested for its ability to help veterans cope with Long COVID by improving psychological adjustment, resilience, and coping skills using established psychotherapeutic techniques in a group setting.

What are the potential side effects?

As this is a psychotherapeutic intervention focusing on mental health recovery rather than medication or medical procedures, traditional physical side effects are not expected; however emotional discomfort may arise as part of the therapeutic process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and make decisions about my health care.

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I may have trouble thinking, remembering, or being in groups.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this outcome will be measured at 2 time points: consent & baseline and immediately post intervention (after the second 8 sessions)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this outcome will be measured at 2 time points: consent & baseline and immediately post intervention (after the second 8 sessions)

This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be measured at 2 time points: consent & baseline and immediately post intervention (after the second 8 sessions) 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 Functional Improvement Post-COVID-19 Over Time

Secondary study objectives

Change in Anxiety Over Time

Change in Depression Over Time

Change in Health-Related Functional Status Over Time

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Long COVID Coping and Recovery (LCCR) InterventionExperimental Treatment1 Intervention

Veterans will participate in a LCCR (1x/week for a total of 16 sessions) via the HIPAA-compliant telehealth platform VA Video Connect (VVC) and/or VA WebEx with two co-therapists.

0 / 3Eligibility criteria met

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

Common treatments for COVID-19 include antiviral agents, steroids, and immunomodulators, which work by reducing viral replication, inflammation, and modulating the immune response. Non-pharmacologic treatments, such as those studied in the Long COVID Coping and Recovery (LCCR) trial, focus on psychotherapeutic interventions aimed at improving psychological adjustment, promoting resilience, and facilitating coping. These interventions are crucial for managing long-term effects like anxiety, depression, and stress-related disorders, addressing both physical and mental health challenges to improve overall patient outcomes.

Long-COVID and Stress Overload: A Direct Link with Psychophysical Disease. A Necessary Interconnection to Focalize Emerging Needs and Necessities.Management and treatment of long COVID symptoms in general practices: An online-based survey.Post-COVID-19 acute sarcopenia: physiopathology and management.