Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention
2 other identifiers
interventional
22
1 country
1
Brief Summary
Post-Acute COVID-19 Syndrome (PACS), colloquially known as Long COVID, is a prevalent phenomenon that affects thousands of Veterans in VA care. VA patients suffering from Long COVID 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 Long COVID treatments primarily target symptom relief and are not designed to promote the recovery and rehabilitation of Veterans in a mental health context. Long COVID Coping and Recovery (LCCR) is a promising manualized, recovery-focused psychotherapeutic group intervention which aims to improve psychological adjustment to Long COVID symptoms, promote resilience, and facilitate coping, based on established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles. The investigators will assess rates of recruitment, intervention engagement, and session attendance (feasibility), Veteran satisfaction (acceptability), treatment adherence (fidelity) and preliminarily explore response to Long COVID Coping and Recovery (LCCR). 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 LCCR for Veterans with Long COVID. This study will pilot test a well-specified, group-based intervention tailored to the unique needs of Veterans with Long COVID. The results of the proposed study will provide data to 1) identify adaptations needed to optimize LCCR for Veterans with Long COVID; 2) identify possible benefits of LCCR; 3) inform development of a large scale RCT of LCCR for Veterans with Long COVID.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedResults Posted
Study results publicly available
April 2, 2025
CompletedApril 2, 2025
March 1, 2025
1.3 years
July 5, 2022
March 13, 2025
March 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Functional Improvement Post-COVID-19 Over Time
Our primary outcome will be changes in symptom severity and subsequent functional improvement (post-COVID-19), as measured by the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm; Sivan et al., 2022). The C19-YRSm is a 17-item self-report scale adapted from the original 22-item COVID-19 Yorkshire Rehabilitation Scale (O'Connor et al., 2022). Items are rated on a scale from 0 (none of this symptom) to 3 (extremely severe level or impact). The C19-YRSm is divided into four subscales: symptom severity, functional disability, other symptoms (item 16), and overall health (item 17). The worst scores for each item within Questions 1-10 form the symptom severity subscale (score 0-30), Questions 11-15 the functional disability subscale (0-15), Question 16 is the other symptoms subscale (score 0-25), and Question 17 is the overall health score (score 0-10). Higher scores indicate more severity. We used the symptom severity, functional disability, and overall health subscales.
This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)
Secondary Outcomes (8)
Change in Health-Related Functional Status Over Time
This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)
Change in Suicide Risk Over Time
This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)
Change in Self-perceived Status on Several Skills Over Time
This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)
Change in Identity Concerns Over Time
This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)
Change in Depression Over Time
This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)
- +3 more secondary outcomes
Study Arms (1)
Long COVID Coping and Recovery (LCCR) Intervention
EXPERIMENTALVeterans 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- U.S. Veteran
- Ages 18-80
- Positive screen for Long COVID (e.g. COVID-19 positive, diagnosed with a PCR test, an antibodies blood test, and or a diagnosis by a physician at the JJPVAMC Long COVID Clinic and symptoms lasting 1 month or longer after infection)
- Participation in VA services at the JJPVAMC
- Sufficient clinical stability and readiness to participate in group therapy as deemed by their VA service provider
You may not qualify if:
- Active alcohol or opiate dependence requiring medically supervised withdrawal
- Active psychosis
- MINI Mental Status \< 23 or inability to function in a group setting
- Unable to operate telehealth platforms or other electronic devices
- Non-English speaking
- Lack of capacity to consent
- Unable or unwilling to provide at least one contact for emergency purposes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marianne Goodman
- Organization
- James J. Peters Veterans Affairs Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne S. Goodman, MD
James J. Peters Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 12, 2022
Study Start
October 1, 2022
Primary Completion
February 1, 2024
Study Completion
September 30, 2024
Last Updated
April 2, 2025
Results First Posted
April 2, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share