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

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05453201
• Other study ID #: D4092-P
• Secondary ID: 1I21RX004092-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: September 30, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, and overall health. Subscales are scored by summing the highest scores for each item, with higher scores indicating greater 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)
Secondary	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). This 36 item assessment has 5 steps ranging from 0 (no limitations) to 4 (extreme limitations) that covers a range of functional limitations in six different domains: understanding and communicating, getting around, self care, getting along with people, life activities- household, life activities-school work, participation in society. Each item receives a raw score, each domain receives a raw score based on the raw score of each item, and each domain receives an average score. Grade 0 reflects the absence of any functional limitation while 5 reflects the presence of extreme health related debilitation. 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).	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	Change in Suicide Risk/Behavior Over Time	Changes in Suicide Risk/ Behavior will be measured by the Suicide Behaviors Questionnaire-Revised (SBQ-R; (Osman et al., 2001). Each item taps into a different dimension of suicidality: (1) lifetime suicidal ideation and/or attempt (2) frequency of suicidal ideation over the past 12 months (3) threat of suicide attempt and (4) self-reported likelihood of future suicidal behavior. Items are summed for a total score (range from 3-18), with higher scores indicating increased severity and 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)
Secondary	Change in Resilience Over Time	Changes in resilience will be measured by the first section of the Measure of Current Status Part A (MOCS) to assess participants' current self-perceived status and potential nonspecific effects of the intervention. The scale uses a 13-item Likert Scale to assess participants' self-perceived proficiency in skills necessary for responding to challenges of everyday life. The scale has 5 steps ranging from 0 ("I can not do this at all") to 4 ("I can do this extremely well"). Higher scores indicate greater self-perceived proficiency of the skills listed. Alphas ranging from 0.71 to 0.89 (Antoni et al., 2006; Antoni et al., 2006a).	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	Change in Identity Concerns Over Time	Changes in identity concerns will be assessed with the Future Self-Continuity Questionnaire, (FSCQ), which measures an individual's sense of personal identity from the present to the future (Sokol & Serper, 2019). This self report instrument uses a 10-item Likert Scale that addresses three areas of future self-continuity: vividness, similarity, and positivity. The scale has 6 steps ranging from 1 ("Not at all") to 6 ("perfectly") to indicate how much participants relate to items assessing their present and future identities. Items are averaged to give the total FSCQ score and higher scores indicate higher levels of Future-Self Continuity (FSC).The FSCQ has demonstrated high levels of reliability ( =.85) and validity.	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	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)
Secondary	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 4-point Likert scale responses (0 = Never to 3 = almost every day). Items are summed for a total score (ranging from 0 to 21). 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)
Secondary	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, 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)
Secondary	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 four-item measures are considered "leading indicators" of implementation success (acceptability and feasibility of intervention and intervention appropriateness) (Proctor et al., 2011).	This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions)