Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention

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.

Study Overview

• Status: Completed
• Conditions: Long COVID
• Intervention / Treatment: Behavioral: Long COVID Coping and Recovery (LCCR) Intervention

Detailed 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) 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 investigator's 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 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.

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 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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468-3904
      • James J. Peters VA Medical Center, Bronx, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. U.S. Veteran
2. Ages 18-80
3. 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)
4. Participation in VA services at the JJPVAMC
5. Sufficient clinical stability and readiness to participate in group therapy as deemed by their VA service provider

Exclusion Criteria:

1. Active alcohol or opiate dependence requiring medically supervised withdrawal
2. Active psychosis
3. MINI Mental Status < 23 or inability to function in a group setting
4. Unable to operate telehealth platforms or other electronic devices
5. Non-English speaking
6. Lack of capacity to consent
7. Unable or unwilling to provide at least one contact for emergency purposes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long COVID Coping and Recovery (LCCR) Intervention; 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.	Behavioral: Long COVID Coping and Recovery (LCCR) Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Over Time	Changes in depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 is a 9-item depression module from the full PHQ with each item representing a depressive symptom. Items are scored on a scale ranging from 0 (not at all) to 3 (nearly every day) to assess the frequency of each symptom over a two-week period. Items are summed for a total score (range from 0-27), with higher scores indicating increased depression severity.	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 Health-Related Functional Status Over Time	Changes in functional status as relates to health will be measured by the World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0; Ustun et al., 2010). The WHODAS. 2.0 has 36 items ranging from 1 (None) to 5 (Extreme or cannot do). Items are summed for subscale scores. There are six domains: 1) understanding and communicating (scores 6-30), 2) getting around (scores 5-25), 3) self-care (scores 4-20), 4) getting along with people (scores 5-25), 5a) life activities-household (scores 4-20), 5b) life activities-school/work (scores 4-20), and 6) participation in society (scores 8-40). Higher scores indicate more difficulties due to health/mental health conditions in each domain. The WHODAS 2.0 has been validated in the general population and amongst those with non-acute health conditions and has a Cronbach's alpha of .96 (Saltychev et al., 2021). We used domains 1, 2, 3, 4, 5a, and 6.	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	Changes in Suicide Risk will be measured by the Suicide Behaviors Questionnaire-Revised (SBQ-R; (Osman et al., 2001). The SBQ-R is a four-item measure of suicide risk. Item 1 measures lifetime suicidal thoughts, plan, and attempt; item 2 measures the frequency of suicidal ideation over the past 12 months; item 3 measures the threat of suicide attempt; and item 4 measures the perceived likelihood of future suicidal behaviors. Items are recoded (item 1: 1-4; item 2: 1-5; item 3: 1-3; item 4: 0-6) and summed for total scores (3-18). Higher scores indicate more risk.	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	The Measure of Current Status (MOCS) has two parts (A and B). We used Part A, which consists of 13 items that measure participants' self-perceived proficiency in skills necessary for responding to challenges of everyday life. Item responses range from 0 (I cannot do this at all) to 4 (I can do this extremely well). We summed items for total scores (possible range: 0-52). Higher scores indicate greater self-perceived proficiency of the skills listed. Reliability alphas range from 0.71 to 0.89 (Antoni et al., 2006).	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	Changes in identity concerns will be assessed with the Future Self-Continuity Questionnaire (FSCQ). The FSCQ measures how individuals perceive themselves in the future in three areas: vividness of the future self, similarity with the future self, and positivity toward the future self. Items range from 1-6. The total FSCQ score is averaged from all items and the total subscales scores (vividness, similarity, and positivity) are averaged from associated items (all total mean scores range from 1-6). Higher subscale scores indicate increased levels of the domain, and higher total scores indicate increased future-self continuity. The FSCQ has demonstrated high levels of reliability ( =.85) and validity. We used the total score and all three subscale scores.	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 Anxiety Over Time	Changes in anxiety symptoms will be measured with the GAD-7 Anxiety (Spitzer et al., 2006). The GAD-7 is a brief self-report measure to assess symptomatology and severity related to Generalized Anxiety Disorder over the course of the last two weeks. The scale has 7 items with a 4-point Likert scale responses (0 = Never to 3 = almost every day). Items are summed for a total score (ranging from 0 to 21), with higher scores indicating increased anxiety severity. The GAD-7 has excellent reliability and validity (Spitzer et al., 2006).	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 Quality of Life Over Time	Changes in quality of life will be measured with the The Quality of Life Scale (QOLS; Burckhardt & Anderson, 2003). The QOLS measures quality of life relevant to diverse patient groups with chronic illness across 6 domains: material and physical well-being, relationships with other people, social, community, and civic activities, personal development and recreation, and independence. There are 16 items with a response scale ranging from 1 (terrible) to 7 (delighted) to indicate levels of satisfaction among the domains. Items are summed for a total score (range: 16-112), with higher scores indicating greater quality of life.	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)
Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.	Changes in Intervention Acceptability, Feasibility, and Appropriateness will be measured by Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (Weiner et al., 2017) at each assessment point. These measures are considered "leading indicators" of implementation success (acceptability and feasibility of intervention and intervention appropriateness) (Proctor et al., 2011). Each measure has four items rated from 1 (completely disagree) to 5 (completely agree). Items are averaged for total scores, and higher scores indicate higher acceptability (AIM), appropriateness (IAM), and feasibility (FIM).	This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Marianne S. Goodman, MD, James J. Peters Veterans Affairs Medical Center

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
• Antoni MH, Lechner SC, Kazi A, Wimberly SR, Sifre T, Urcuyo KR, Phillips K, Gluck S, Carver CS. How stress management improves quality of life after treatment for breast cancer. J Consult Clin Psychol. 2006 Dec;74(6):1143-52. doi: 10.1037/0022-006X.74.6.1152.
• Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001 Dec;8(4):443-54. doi: 10.1177/107319110100800409.
• Taquet M, Dercon Q, Luciano S, Geddes JR, Husain M, Harrison PJ. Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19. PLoS Med. 2021 Sep 28;18(9):e1003773. doi: 10.1371/journal.pmed.1003773. eCollection 2021 Sep.
• Lerner AM, Robinson DA, Yang L, Williams CF, Newman LM, Breen JJ, Eisinger RW, Schneider JS, Adimora AA, Erbelding EJ. Toward Understanding COVID-19 Recovery: National Institutes of Health Workshop on Postacute COVID-19. Ann Intern Med. 2021 Jul;174(7):999-1003. doi: 10.7326/M21-1043. Epub 2021 Mar 30.
• Saltychev M, Katajapuu N, Barlund E, Laimi K. Psychometric properties of 12-item self-administered World Health Organization disability assessment schedule 2.0 (WHODAS 2.0) among general population and people with non-acute physical causes of disability - systematic review. Disabil Rehabil. 2021 Mar;43(6):789-794. doi: 10.1080/09638288.2019.1643416. Epub 2019 Jul 23.
• Sokol Y, Serper M. Development and Validation of a Future Self-Continuity Questionnaire: A Preliminary Report. J Pers Assess. 2020 Sep-Oct;102(5):677-688. doi: 10.1080/00223891.2019.1611588. Epub 2019 May 20.
• Sivan M, Preston N, Parkin A, Makower S, Gee J, Ross D, Tarrant R, Davison J, Halpin S, O'Connor RJ, Horton M. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) patient-reported outcome measure for Long Covid or Post-COVID-19 syndrome. J Med Virol. 2022 Sep;94(9):4253-4264. doi: 10.1002/jmv.27878. Epub 2022 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; COVID-19; Functional Improvement; Long-Haul COVID; Post-Acute COVID-19 Syndrome (PACS)
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: D4092-P; 1I21RX004092-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No