PACS Coping and Recovery (PACS-CR) Intervention for Post-acute COVID-19 Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
James J. Peters VA Medical Center, Bronx, NY, Bronx, NY
Post-acute COVID-19 Syndrome+2 More
PACS Coping and Recovery (PACS-CR) Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Post-Acute COVID-19 Syndrome (PACS) is a prevalent phenomenon that affects thousands of Veterans in VA care. VA patients suffering from PACS not only experience lingering physical symptoms following COVID-19 infection, but have increased mental health problems including sleep disorders, anxiety disorders, trauma and stress-related disorders as well as increased use of opioid and non-opioid pain medications, antidepressants, and sedatives to treat these conditions. Developing recovery-oriented care, "a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential" is a VA priority, however available PACS treatments primarily target symptom relief and are not designed to promote the recovery and rehabilitation of Veterans in a mental health context. PACS Coping and Recovery (PACS-CR) is a promising manualized, recovery-focused psychotherapeutic group intervention which aims to improve psychological adjustment to PACS symptoms, promote resilience, and facilitate coping, based on established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles. The proposed study has two stages: First: Test and enhance the PACS-CR treatment materials using Veteran feedback, stakeholder feedback, and acceptability and feasibility data. Then, with the guidance of scientific and Veteran consumer advisory boards, use these results to update the treatment. Second: conduct a pilot Randomized Controlled Trial (RCT) to assess feasibility and acceptability of the treatment materials and research protocol, specifically looking at the outcome measures and assessment strategy. The investigators will assess rates of recruitment, intervention engagement, and session attendance (feasibility), Veteran satisfaction (acceptability), treatment adherence (fidelity) and preliminarily explore response to PACS-CR. Findings will be used to make a final adaptation of the treatment materials and to develop a research protocol for a large scale RCT of PACS-CR for Veterans with PACS. This study will pilot test a well-specified, group-based intervention tailored to the unique needs of Veterans with PACS. The results of the proposed study will provide data to 1) identify adaptations needed to optimize PACS-CR for Veterans with PACS: 2) identify possible benefits of PACS-CR; 3) inform development of a large scale RCT of PACS-CR for Veterans with PACS.

Eligible Conditions

  • Post-acute COVID-19 Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: This outcome will be measured at 3 time points: Consent & baseline, immediately post-intervention (upon completion of 12 week program), 3-month follow-up

Week 12
Change in Functional Improvement Post-COVID-19 Over Time
Change in Health-Related Functional Status Over Time
Change in Identity Concerns Over Time
Change in Life Direction Over Time
Change in Pain Interference Over Time
Change in Psychological Functioning Over Time
Change in Resilience Over Time
Change in Suicide Risk/Behavior Over Time
Change in Well-Being Over Time

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

PACS Coping and Recovery (PACS-CR) Intervention
1 of 1
Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: PACS Coping and Recovery (PACS-CR) Intervention · No Placebo Group · N/A

PACS Coping and Recovery (PACS-CR) Intervention
Behavioral
Experimental Group · 1 Intervention: PACS Coping and Recovery (PACS-CR) Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: this outcome will be measured at 3 time points: consent & baseline, immediately post-intervention (upon completion of 12 week program), 3-month follow-up
Closest Location: James J. Peters VA Medical Center, Bronx, NY · Bronx, NY
Photo of Bronx  1Photo of Bronx  2Photo of Bronx  3
2007First Recorded Clinical Trial
1 TrialsResearching Post-acute COVID-19 Syndrome
25 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with a PCR test or an antibodies blood test and/or symptoms lasting 1 month or longer after infection.
You have a significant impairment in at least one of the nine domains of psychological functioning.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References