Trial Outcomes & Findings for Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention (NCT NCT05453201)
NCT ID: NCT05453201
Last Updated: 2025-04-02
Results Overview
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.
COMPLETED
NA
22 participants
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)
2025-04-02
Participant Flow
One participant withdrew after signing the consent form before beginning treatment due to lack of interest in participating.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
One participant was missing item 1 at baseline, so a total baseline SBQ-R could not be calculated.
Baseline characteristics by cohort
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=21 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=21 Participants
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Age, Categorical
Between 18 and 65 years
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15 Participants
n=21 Participants
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Age, Categorical
>=65 years
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6 Participants
n=21 Participants
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Age, Continuous
|
57.363 years
STANDARD_DEVIATION 11.97 • n=21 Participants
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Sex: Female, Male
Female
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6 Participants
n=21 Participants
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Sex: Female, Male
Male
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15 Participants
n=21 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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13 Participants
n=21 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=21 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=21 Participants
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Race/Ethnicity, Customized
Race · Black/African American
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11 Participants
n=21 Participants
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Race/Ethnicity, Customized
Race · White/Caucasian
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5 Participants
n=21 Participants
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Race/Ethnicity, Customized
Race · Muti-racial
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2 Participants
n=21 Participants
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Race/Ethnicity, Customized
Race · Other
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3 Participants
n=21 Participants
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Region of Enrollment
United States
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21 Participants
n=21 Participants
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Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Functional disability
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8.05 scores on a scale
STANDARD_DEVIATION 4.93 • n=21 Participants
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Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Symptom severity
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20.67 scores on a scale
STANDARD_DEVIATION 4.63 • n=21 Participants
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Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Perceived overall health
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4.67 scores on a scale
STANDARD_DEVIATION 1.98 • n=21 Participants
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World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0)
Domain 1
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14.86 scores on a scale
STANDARD_DEVIATION 5.11 • n=21 Participants
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World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0)
Domain 2
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14.71 scores on a scale
STANDARD_DEVIATION 4.62 • n=21 Participants
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World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0)
Domain 3
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7.62 scores on a scale
STANDARD_DEVIATION 2.73 • n=21 Participants
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World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0)
Domain 4
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10.71 scores on a scale
STANDARD_DEVIATION 4.35 • n=21 Participants
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World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0)
Domain 5 (Part A)
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11.71 scores on a scale
STANDARD_DEVIATION 4.45 • n=21 Participants
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World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0)
Domain 6
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21.48 scores on a scale
STANDARD_DEVIATION 8.87 • n=21 Participants
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Suicidal Behaviors Questionnaire-Revised (SBQ-R)
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5.2 scores on a scale
STANDARD_DEVIATION 3.14 • n=20 Participants • One participant was missing item 1 at baseline, so a total baseline SBQ-R could not be calculated.
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Measure of Current Status (MOCS - Part A)
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26.19 scores on a scale
STANDARD_DEVIATION 6.71 • n=21 Participants
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Future Self-Continuity Questionnaire (FSCQ)
Overall
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3.46 scores on a scale
STANDARD_DEVIATION 1.00 • n=21 Participants
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Future Self-Continuity Questionnaire (FSCQ)
Similarity subscale
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3.57 scores on a scale
STANDARD_DEVIATION 1.46 • n=21 Participants
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Future Self-Continuity Questionnaire (FSCQ)
Vividness subscale
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3.16 scores on a scale
STANDARD_DEVIATION 0.79 • n=21 Participants
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Future Self-Continuity Questionnaire (FSCQ)
Positivity subscale
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3.60 scores on a scale
STANDARD_DEVIATION 1.53 • n=21 Participants
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Patient Health Questionnaire-9 (PHQ-9)
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12.81 scores on a scale
STANDARD_DEVIATION 6.38 • n=21 Participants
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General Anxiety Disorder-7 (GAD-7)
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10.87 scores on a scale
STANDARD_DEVIATION 6.64 • n=21 Participants
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Quality of Life Scale (QOLS)
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66.42 scores on a scale
STANDARD_DEVIATION 15.3 • n=21 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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Change in Functional Improvement Post-COVID-19 Over Time
Functional disability - pre
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8.4 score on a scale
Standard Deviation 4.78
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Change in Functional Improvement Post-COVID-19 Over Time
Symptom severity - pre
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21.05 score on a scale
Standard Deviation 4.39
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Change in Functional Improvement Post-COVID-19 Over Time
Overall health - pre
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4.55 score on a scale
Standard Deviation 1.96
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Change in Functional Improvement Post-COVID-19 Over Time
Functional disability - post
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6.6 score on a scale
Standard Deviation 3.2
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Change in Functional Improvement Post-COVID-19 Over Time
Symptom severity - post
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17.25 score on a scale
Standard Deviation 5.18
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Change in Functional Improvement Post-COVID-19 Over Time
Overall health - post
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5.5 score on a scale
Standard Deviation 1.7
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 1 - pre
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15.1 score on a scale
Standard Deviation 5.12
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 2 - pre
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15.1 score on a scale
Standard Deviation 4.38
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 3 - pre
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7.8 score on a scale
Standard Deviation 2.67
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 4 - pre
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10.95 score on a scale
Standard Deviation 4.32
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 5a - pre
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11.9 score on a scale
Standard Deviation 4.48
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 6 - pre
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22 score on a scale
Standard Deviation 8.76
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 1 - post
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14.15 score on a scale
Standard Deviation 3.86
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 2 - post
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14.05 score on a scale
Standard Deviation 3.58
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 3 - post
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7.25 score on a scale
Standard Deviation 2.9
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 4 - post
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11.2 score on a scale
Standard Deviation 4.50
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 5a - post
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10.9 score on a scale
Standard Deviation 3.96
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Change in Health-Related Functional Status Over Time
WHODAS 2.0 domain 6 - post
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20.35 score on a scale
Standard Deviation 8.01
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=19 Participants
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.
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|---|---|
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Change in Suicide Risk Over Time
SBQ-R - pre
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4.89 score on a scale
Standard Deviation 2.9
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Change in Suicide Risk Over Time
SBQ-R - post
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5.05 score on a scale
Standard Deviation 3.22
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Change in Self-perceived Status on Several Skills Over Time
MOCS - pre
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27.05 score on a scale
Standard Deviation 5.58
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Change in Self-perceived Status on Several Skills Over Time
MOCS - post
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27.50 score on a scale
Standard Deviation 6.12
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Change in Identity Concerns Over Time
FSCQ vividness subscale - post
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3.27 score on a scale
Standard Deviation .93
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Change in Identity Concerns Over Time
FSCQ total score - pre
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3.52 score on a scale
Standard Deviation .99
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Change in Identity Concerns Over Time
FSCQ similarity subscale - pre
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3.68 score on a scale
Standard Deviation 1.42
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Change in Identity Concerns Over Time
FSCQ vividness subscale - pre
|
3.18 score on a scale
Standard Deviation .8
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Change in Identity Concerns Over Time
FSCQ positive subscale - pre
|
3.65 score on a scale
Standard Deviation 1.55
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Change in Identity Concerns Over Time
FSCQ total score - post
|
3.54 score on a scale
Standard Deviation 1.03
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Change in Identity Concerns Over Time
FSCQ similarity subscale - post
|
3.5 score on a scale
Standard Deviation 1.34
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Change in Identity Concerns Over Time
FSCQ positive subscale - post
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3.87 score on a scale
Standard Deviation 1.22
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Change in Depression Over Time
PHQ-9 - pre
|
12.95 score on a scale
Standard Deviation 6.52
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Change in Depression Over Time
PHQ-9 - post
|
8.65 score on a scale
Standard Deviation 4.90
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Change in Anxiety Over Time
GAD-7 - pre
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11.01 score on a scale
Standard Deviation 6.78
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Change in Anxiety Over Time
GAD-7 - post
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7.95 score on a scale
Standard Deviation 5.56
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Change in Quality of Life Over Time
QOLS - pre
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66.34 score on a scale
Standard Deviation 15.69
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Change in Quality of Life Over Time
QOLS - post
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72.75 score on a scale
Standard Deviation 14.09
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=20 Participants
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.
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|---|---|
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Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.
Feasibility - pre
|
3.96 score on a scale
Standard Deviation .70
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Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.
Feasibility - post
|
4.15 score on a scale
Standard Deviation .75
|
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Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.
Acceptability - pre
|
4.04 score on a scale
Standard Deviation .80
|
|
Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.
Appropriateness - pre
|
4.16 score on a scale
Standard Deviation .77
|
|
Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.
Acceptability - post
|
4.26 score on a scale
Standard Deviation .75
|
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Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.
Appropriateness - post
|
4.20 score on a scale
Standard Deviation .79
|
Adverse Events
Long COVID Coping and Recovery (LCCR) Intervention
Serious adverse events
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=21 participants at risk
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.
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|---|---|
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Surgical and medical procedures
Abdominal Surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Reproductive system and breast disorders
Gynecological Surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Cardiac disorders
Emergency Department visit for chest pain
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Cardiac disorders
Emergency Department visit and hospitalization for dizziness and chest pain
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
Emergency Department visit and hospitalization for shortness of breath
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Cardiac disorders
Cardiac Surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
Emergency Department visit and hospitalization for COVID-19
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Surgical and medical procedures
Hip Replacement Surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
Other adverse events
| Measure |
Long COVID Coping and Recovery (LCCR) Intervention
n=21 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Emergency Department visit for cough and fever
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
Emergency Department visit for COVID-19
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Surgical and medical procedures
Oral Surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
Emergency Department visit for shortness of breath
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Surgical and medical procedures
Hand Surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Musculoskeletal and connective tissue disorders
Emergency Department visit for back pain
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Musculoskeletal and connective tissue disorders
Emergency Department visit for hip pain
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Cardiac disorders
Emergency Department visit for EKG irregularity
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
|
Endocrine disorders
Emergency Department visit for groin pain and hyperglycemia
|
100.0%
1/1 • Number of events 1 • Adverse event data were collected throughout the course of participant enrollment in the study (about 13 months).
|
Additional Information
Dr. Marianne Goodman
James J. Peters Veterans Affairs Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place