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Long COVIDNCT05453201

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

A study testing Long COVID Coping and Recovery (LCCR) Intervention in people with Long COVID, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Long COVID
What is being tested?
Long COVID Coping and Recovery (LCCR) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 30 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468-3904

Other trials in United States

About this study

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.

Read the 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.

Conditions
Long COVID
Being tested
Long COVID Coping and Recovery (LCCR) Intervention
Keywords
COVID-19, Functional Improvement, Long-Haul COVID, Mental Health, Post-Acute COVID-19 Syndrome (PACS)
Medical subject headings
Post-Acute COVID-19 Syndrome, COVID-19, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Long COVID Coping and Recovery (LCCR) InterventionBehavioural

    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.

Study groups in NCT05453201
Study groupRoleWhat they receive
Long COVID Coping and Recovery (LCCR) InterventionExperimentalVeterans 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.
Receives: Behavioral: Long COVID Coping and Recovery (LCCR) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (8)
  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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).

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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).

    Measured: 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)

  7. 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.

    Measured: 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)

  8. 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).

    Measured: This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start1 Oct 2022
  3. Primary completion1 Feb 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
PACS Patients will be recruited through recruitment from James J. Peters VAMC PACS clinical program and clinician referrals. The Bronx had significantly higher rates of COVID-19 infection than other boroughs in New York City. Thus, recruitment of up to 36 Veterans is feasible within the 18-month timeframe. Veterans will participate in a LCCR group (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.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05453201
Sponsor's protocol ID
D4092-P
Other IDs
1I21RX004092-01A1
Status last verified
Mar 2025
First submitted
5 Jul 2022
Last updated
2 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Long COVID Coping and Recovery (LCCR) Intervention in people with Long COVID, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Improvement Post-COVID-19 Over Time (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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