Long COVID
Conditions
Keywords
COVID-19, Functional Improvement, Long-Haul COVID, Mental Health, Post-Acute COVID-19 Syndrome (PACS)
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.
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.
Interventions
BEHAVIORALLong 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Improvement Post-COVID-19 Over Time | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicide Risk Over Time | 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 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. |
| Change in Self-perceived Status on Several Skills Over Time | 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) | 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). |
| Change in Identity Concerns Over Time | 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 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. |
| Change in Health-Related Functional Status Over Time | 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 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. |
| Change in Anxiety Over Time | 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 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). |
| Change in Quality of Life Over Time | 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 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. |
| Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions) | 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). |
| Change in Depression Over Time | 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 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant withdrew after signing the consent form before beginning treatment due to lack of interest in participating.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Long COVID Coping and Recovery (LCCR) Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 57.363 years STANDARD_DEVIATION 11.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Future Self-Continuity Questionnaire (FSCQ) Overall | 3.46 scores on a scale STANDARD_DEVIATION 1 |
| Future Self-Continuity Questionnaire (FSCQ) Positivity subscale | 3.60 scores on a scale STANDARD_DEVIATION 1.53 |
| Future Self-Continuity Questionnaire (FSCQ) Similarity subscale | 3.57 scores on a scale STANDARD_DEVIATION 1.46 |
| Future Self-Continuity Questionnaire (FSCQ) Vividness subscale | 3.16 scores on a scale STANDARD_DEVIATION 0.79 |
| General Anxiety Disorder-7 (GAD-7) | 10.87 scores on a scale STANDARD_DEVIATION 6.64 |
| Measure of Current Status (MOCS - Part A) | 26.19 scores on a scale STANDARD_DEVIATION 6.71 |
| Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) Functional disability | 8.05 scores on a scale STANDARD_DEVIATION 4.93 |
| Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) Perceived overall health | 4.67 scores on a scale STANDARD_DEVIATION 1.98 |
| Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) Symptom severity | 20.67 scores on a scale STANDARD_DEVIATION 4.63 |
| Patient Health Questionnaire-9 (PHQ-9) | 12.81 scores on a scale STANDARD_DEVIATION 6.38 |
| Quality of Life Scale (QOLS) | 66.42 scores on a scale STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized Race Black/African American | 11 Participants |
| Race/Ethnicity, Customized Race Muti-racial | 2 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 5 Participants |
| Region of Enrollment United States | 21 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 15 Participants |
| Suicidal Behaviors Questionnaire-Revised (SBQ-R) | 5.2 scores on a scale STANDARD_DEVIATION 3.14 |
| World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0) Domain 1 | 14.86 scores on a scale STANDARD_DEVIATION 5.11 |
| World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0) Domain 2 | 14.71 scores on a scale STANDARD_DEVIATION 4.62 |
| World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0) Domain 3 | 7.62 scores on a scale STANDARD_DEVIATION 2.73 |
| World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0) Domain 4 | 10.71 scores on a scale STANDARD_DEVIATION 4.35 |
| World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0) Domain 5 (Part A) | 11.71 scores on a scale STANDARD_DEVIATION 4.45 |
| World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0) Domain 6 | 21.48 scores on a scale STANDARD_DEVIATION 8.87 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 9 / 21 |
| serious Total, serious adverse events | 5 / 21 |
Outcome results
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 (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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Functional Improvement Post-COVID-19 Over Time | Functional disability - pre | 8.4 score on a scale | Standard Deviation 4.78 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Functional Improvement Post-COVID-19 Over Time | Symptom severity - pre | 21.05 score on a scale | Standard Deviation 4.39 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Functional Improvement Post-COVID-19 Over Time | Overall health - pre | 4.55 score on a scale | Standard Deviation 1.96 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Functional Improvement Post-COVID-19 Over Time | Functional disability - post | 6.6 score on a scale | Standard Deviation 3.2 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Functional Improvement Post-COVID-19 Over Time | Symptom severity - post | 17.25 score on a scale | Standard Deviation 5.18 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Functional Improvement Post-COVID-19 Over Time | Overall health - post | 5.5 score on a scale | Standard Deviation 1.7 |
Comparison: This analysis uses the functional disability subscale from pre- to post-intervention.p-value: 0.06paired t-test
Comparison: This analysis uses the symptom severity subscale from pre- to post-intervention.p-value: 0.004paired t-test
Comparison: This analysis uses the perceived overall health now subscale (1 item) from pre- to post-intervention.p-value: 0.1paired t-test
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 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).
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Anxiety Over Time | GAD-7 - pre | 11.01 score on a scale | Standard Deviation 6.78 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Anxiety Over Time | GAD-7 - post | 7.95 score on a scale | Standard Deviation 5.56 |
Comparison: This analysis uses the GAD-7 from pre- to post-intervention.p-value: 0.01paired t-test
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Depression Over Time | PHQ-9 - pre | 12.95 score on a scale | Standard Deviation 6.52 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Depression Over Time | PHQ-9 - post | 8.65 score on a scale | Standard Deviation 4.9 |
Comparison: This analysis uses the PHQ-9 from pre- to post-intervention.p-value: 0.003paired t-test
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). 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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 1 - pre | 15.1 score on a scale | Standard Deviation 5.12 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 2 - pre | 15.1 score on a scale | Standard Deviation 4.38 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 4 - pre | 10.95 score on a scale | Standard Deviation 4.32 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 5a - pre | 11.9 score on a scale | Standard Deviation 4.48 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 6 - pre | 22 score on a scale | Standard Deviation 8.76 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 3 - pre | 7.8 score on a scale | Standard Deviation 2.67 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 1 - post | 14.15 score on a scale | Standard Deviation 3.86 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 2 - post | 14.05 score on a scale | Standard Deviation 3.58 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 3 - post | 7.25 score on a scale | Standard Deviation 2.9 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 4 - post | 11.2 score on a scale | Standard Deviation 4.5 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 5a - post | 10.9 score on a scale | Standard Deviation 3.96 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Health-Related Functional Status Over Time | WHODAS 2.0 domain 6 - post | 20.35 score on a scale | Standard Deviation 8.01 |
Comparison: This analysis uses domain 1 from pre- to post-intervention.p-value: 0.46paired t-test
Comparison: This analysis uses domain 2 from pre- to post-intervention.p-value: 0.2paired t-test
Comparison: This analysis uses domain 3 from pre- to post-intervention.p-value: 0.42paired t-test
Comparison: This analysis uses domain 4 from pre- to post-intervention.p-value: 0.84paired t-test
Comparison: This analysis uses domain 5 (part 1) from pre- to post-intervention.p-value: 0.25paired t-test
Comparison: This analysis uses domain 6 from pre- to post-intervention.p-value: 0.26paired t-test
Secondary
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ similarity subscale - pre | 3.68 score on a scale | Standard Deviation 1.42 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ total score - pre | 3.52 score on a scale | Standard Deviation 0.99 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ vividness subscale - pre | 3.18 score on a scale | Standard Deviation 0.8 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ positive subscale - pre | 3.65 score on a scale | Standard Deviation 1.55 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ total score - post | 3.54 score on a scale | Standard Deviation 1.03 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ similarity subscale - post | 3.5 score on a scale | Standard Deviation 1.34 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ vividness subscale - post | 3.27 score on a scale | Standard Deviation 0.93 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Identity Concerns Over Time | FSCQ positive subscale - post | 3.87 score on a scale | Standard Deviation 1.22 |
Comparison: This analysis uses the FSCQ score (all items) from pre- to post-intervention.p-value: 0.92paired t-test
Comparison: This analysis uses the FSCQ similarity subscale from pre- to post-intervention.p-value: 0.9Wilcoxon test (paired)
Comparison: This analysis uses the FSCQ vividness subscale from pre- to post-intervention.p-value: 0.74paired t-test
Comparison: This analysis uses the FSCQ positivity subscale from pre- to post-intervention.p-value: 0.44paired t-test
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 (range: 16-112), with higher scores indicating greater quality of life.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Quality of Life Over Time | QOLS - pre | 66.34 score on a scale | Standard Deviation 15.69 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Quality of Life Over Time | QOLS - post | 72.75 score on a scale | Standard Deviation 14.09 |
Comparison: This analysis uses the QOLS from pre- to post-intervention.p-value: 0.04paired t-test
Secondary
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).
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Self-perceived Status on Several Skills Over Time | MOCS - pre | 27.05 score on a scale | Standard Deviation 5.58 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Self-perceived Status on Several Skills Over Time | MOCS - post | 27.50 score on a scale | Standard Deviation 6.12 |
Comparison: This analysis uses the MOCS (part A) from pre- to post-intervention.p-value: 0.8paired t-test
Secondary
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.
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)
Population: One participant was missing item 1 of the SBQ-R and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Suicide Risk Over Time | SBQ-R - pre | 4.89 score on a scale | Standard Deviation 2.9 |
| Long COVID Coping and Recovery (LCCR) Intervention | Change in Suicide Risk Over Time | SBQ-R - post | 5.05 score on a scale | Standard Deviation 3.22 |
Comparison: This analysis uses the SBQ-R total score from pre- to post-intervention.p-value: 0.89Wilcoxon test
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 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).
Time frame: This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long COVID Coping and Recovery (LCCR) Intervention | Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | Acceptability - post | 4.26 score on a scale | Standard Deviation 0.75 |
| Long COVID Coping and Recovery (LCCR) Intervention | Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | Acceptability - pre | 4.04 score on a scale | Standard Deviation 0.8 |
| Long COVID Coping and Recovery (LCCR) Intervention | Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | Appropriateness - pre | 4.16 score on a scale | Standard Deviation 0.77 |
| Long COVID Coping and Recovery (LCCR) Intervention | Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | Feasibility - pre | 3.96 score on a scale | Standard Deviation 0.7 |
| Long COVID Coping and Recovery (LCCR) Intervention | Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | Appropriateness - post | 4.20 score on a scale | Standard Deviation 0.79 |
| Long COVID Coping and Recovery (LCCR) Intervention | Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time. | Feasibility - post | 4.15 score on a scale | Standard Deviation 0.75 |
p-value: 0.24Paired t-test
p-value: 0.82Paired t-test
Comparison: The FIM measures an intervention's feasibility. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention feasibility. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the FIM at pre- and post-intervention.p-value: 0.38Paired t-test