Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05453201
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-07-05
Brief Title:
Developing an Integrative Recovery-Based Post-Acute COVID-19 Syndrome PACS Psychotherapeutic Intervention
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Developing an Integrative Recovery-Based Post-Acute COVID-19 Syndrome PACS Psychotherapeutic Intervention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Epidemiological estimates suggest that approximately 11390400 Americans and 90300 Veterans in VA care experience symptoms for months after initial COVID-19 infection a phenomenon known as Post-Acute COVID-19 Syndrome PACS or Long COVID Common symptoms of Long COVID 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 Long COVID 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 Long COVID 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 Long COVID 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 investigators proposed intervention Long COVID Coping and Recovery LCCR aims to improve psychological adjustment to Long COVID symptoms promote resiliency and facilitate coping all of which can impact functional status and quality of life LCCR is designed to help to build a relevant and personally meaningful action plan to address the symptoms Veterans may be experiencing due to Long COVID and to assist Veterans with Long COVID in managing their illness increasing function and moving towards recovery LCCR focuses on psychological adjustment and coping and augments medical rehabilitation and neurological treatment for this population The investigators 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
Based on adaptations from existing recovery-based and COVID-19 distress group interventions that the team has developedpiloted the investigators have developed a treatment framework that consists of sixteen 60-minute weekly group sessions The investigators specifically are designing a group intervention to build support and mitigate the loneliness associated with chronic conditions such as Long COVID The sessions will focus on the impact of Long COVID on mental and physical health teach coping skills to foster resiliency and hope and developing a sense of purpose and meaning in life even when living with a chronic condition like Long COVID
Overall Goal To pilot a Post-Acute COVID-19 Syndrome PACS psychotherapeutic intervention Long COVID Coping and Recovery LCCR while collecting pilot data to assess its acceptability and feasibility
Aim 1 Identify adaptations needed to optimize LCCR for Veterans with Long COVID through Veteran and stakeholder consultation
Aim 2 Identify possible benefits of LCCR Aim 3 Inform development of a large scale RCT of LCCR for Veterans with Long COVID
The investigators proposed intervention Long COVID Coping and Recovery LCCR aims to improve psychological adjustment to Long COVID symptoms promote resiliency and facilitate coping all of which can impact functional status and quality of life LCCR is designed to help to build a relevant and personally meaningful action plan to address the symptoms Veterans may be experiencing due to Long COVID and to assist Veterans with Long COVID in managing their illness increasing function and moving towards recovery LCCR focuses on psychological adjustment and coping and augments medical rehabilitation and neurological treatment for this population The investigators 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
Based on adaptations from existing recovery-based and COVID-19 distress group interventions that the team has developedpiloted the investigators have developed a treatment framework that consists of sixteen 60-minute weekly group sessions The investigators specifically are designing a group intervention to build support and mitigate the loneliness associated with chronic conditions such as Long COVID The sessions will focus on the impact of Long COVID on mental and physical health teach coping skills to foster resiliency and hope and developing a sense of purpose and meaning in life even when living with a chronic condition like Long COVID
Overall Goal To pilot a Post-Acute COVID-19 Syndrome PACS psychotherapeutic intervention Long COVID Coping and Recovery LCCR while collecting pilot data to assess its acceptability and feasibility
Aim 1 Identify adaptations needed to optimize LCCR for Veterans with Long COVID through Veteran and stakeholder consultation
Aim 2 Identify possible benefits of LCCR Aim 3 Inform development of a large scale RCT of LCCR for Veterans with Long COVID
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I21RX004092-01A1 | NIH | None | httpsreporternihgovquickSearch1I21RX004092-01A1 |