Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention
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- STATUS
- Recruiting
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- End date
- Sep 30, 2024
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- participants needed
- 36
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- sponsor
- VA Office of Research and Development
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.
Description
Epidemiological estimates suggest that approximately 11,390,400 Americans, and 90,300 Veterans in VA care experience symptoms for months after initial COVID-19 infection, a phenomenon known as Post-Acute COVID-19 Syndrome (PACS). Common symptoms of PACS include prolonged fatigue, impairment of memory, concentration disorder, headache, pain, insomnia, anxiety, post-traumatic stress disorder (PTSD), and depression (Taquet et al., 2021). Longer term effects of COVID-19 have been reported in all age groups and demographics including persons with asymptomatic, mild, or severe initial COVID-19 infection. Despite PACS symptoms resulting in significant functional impairment, there are few empirically supported treatment approaches specifically designed to address this population. Many in the field contend that given the complexity and variability of PACS manifestations, successful treatment cannot be considered from a single organ point of view, but rather require a patient-tailored multidisciplinary approach that steps beyond amelioration of psychological symptoms (Ambrosino et al., 2021; Lerner et al., 2021). PACS treatment requires specialists across medical, neurological, rehabilitation, and mental health fields in conjunction with recovery-based approaches such as Whole Health, and Chaplain Services.
The investigator's proposed intervention, PACS Coping and Recovery (PACS-CR), aims to improve psychological adjustment to PACS symptoms, promote resiliency, and facilitate coping, all of which can impact functional status and quality of life. PACS-CR is designed to help to build a relevant and personally meaningful action plan to address the symptoms Veterans may be experiencing due to PACS and to assist Veterans with PACS in managing their illness, increasing function, and moving towards recovery. PACS-CR focuses on psychological adjustment and coping, and augments medical, rehabilitation, and neurological treatment for this population. The investigator's approach is based on the CHIME model of personal recovery which includes five overarching processes: 1) Connectedness; 2) Hope and optimism about the future; 3) Identity; 4) Meaning in life; and 5) Empowerment. The investigators will target the CHIME processes using established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles. The investigator's integrative approach will incorporate rehabilitative strategies from specialists treating PACS patients (e.g., pulmonologists; nutritionists; chaplains; rehabilitation therapists, etc.) with the focus of restoring functional capacities, fostering resiliency, and bolstering life satisfaction.
Based on adaptations from existing recovery-based and COVID-19 distress group interventions that the team has developed/piloted, the investigators have developed a treatment framework that consists of twelve 90-minute weekly "core" group sessions, with an additional twelve optional topical sessions co-led by specialists. The investigators specifically are designing a group intervention to build support and mitigate the loneliness associated with chronic conditions such as PACS. The core sessions will focus on the impact of PACS on mental and physical health, teach coping skills to foster resiliency and hope, identify barriers to employment/education due to PACS, and review relapse prevention.
Overall Goal: To pilot a Post-Acute COVID-19 Syndrome (PACS) psychotherapeutic intervention, "PACS Coping and Recovery" (PACS-CR) while collecting pilot data to assess its acceptability and feasibility.
Aim 1: Identify adaptations needed to optimize PACS-CR for Veterans with PACS through Veteran and stakeholder consultation.
Aim 2: Identify possible benefits of PACS-CR. Aim 3: Inform development of a large scale RCT of PACS-CR for Veterans with PACS.
Details
| Condition | Post-acute COVID-19 Syndrome |
|---|---|
| Treatment | PACS Coping and Recovery (PACS-CR) Intervention |
| Clinical Study Identifier | NCT05453201 |
| Sponsor | VA Office of Research and Development |
| Last Modified on | 23 October 2022 |
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