N/A
N=21
Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention
Long COVID
Bottom Line
View on ClinicalTrials.gov: NCT05453201 ↗Enrolled (actual)
21
Serious AEs
23.8%
Results posted
Apr 2025
Primary outcome: Primary: Change in Functional Improvement Post-COVID-19 Over Time — 8.4; 21.05; 4.55; 6.6 score on a scale — p=.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Long COVID Coping and Recovery (LCCR) Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Functional Improvement Post-COVID-19 Over Time |
8.4; 21.05; 4.55; 6.6; 17.25; 5.5 | .06 |
| SECONDARY Change in Health-Related Functional Status Over Time |
15.1; 15.1; 7.8; 10.95; 11.9; 22 | .46 |
| SECONDARY Change in Suicide Risk Over Time |
4.89; 5.05 | .89 |
| SECONDARY Change in Self-perceived Status on Several Skills Over Time |
27.05; 27.50 | .80 |
| SECONDARY Change in Identity Concerns Over Time |
3.52; 3.68; 3.18; 3.65; 3.54; 3.5 | .92 |
| SECONDARY Change in Depression Over Time |
12.95; 8.65 | .003 sig |
| SECONDARY Change in Anxiety Over Time |
11.01; 7.95 | .01 sig |
| SECONDARY Change in Quality of Life Over Time |
66.34; 72.75 | .04 sig |
| SECONDARY Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. |
4.04; 4.16; 3.96; 4.26; 4.20; 4.15 | .24 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05453201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.