Exercise in Adults With Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection Study

COVID-19 Clinical Trial

— PASC  

Official title:

Exercise Training and Functional, Cognitive, and Emotional Well-being in Adults With Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection (PASC): a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218174
• Other study ID #: 021-347
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: Baylor Research Institute
• Contact: Taylor Gilliland, MS
• Phone: 214-603-1527
• Email: taylor.gilliland[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.

Description:

Conduct a randomized control trial with a wait-list control to examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.

Examine participant compliance (in-person attendance, online engagement) with the 8-week exercise training program including in-person exercise sessions, cognitive performance training, and virtual exercise sessions delivered via a mobile application.

To determine if compliance with the 8-week exercise training program is associated with improvement in functional, cognitive, and emotional health outcomes.

Determine if there is a maintenance effect for individuals randomized into the 8-week exercise training program by comparing their outcomes at the end of the 8-week training exercise program to their outcomes at the end of their trial participation (16 weeks).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years of age

• Self-reported history of COVID-19 diagnosis

• Self-reported ongoing symptoms of PASC >4 weeks after initial infection

Exclusion Criteria:

• Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation

• COVID-19 infection occurring > 6 months prior to screening date

• Contraindications to Symptom-limited Maximal Exercise Testing

• Individuals without access to a device with iOS (apple devices such as iPhone, iPad, MacBook, etc.)

• Patient-reported diagnosis of severe arterial hypertension

• Patient reported metabolic disease

• Patient reported uncontrolled asthma

• Inmates

• Pregnancy

• Patient reported supplemental O2 use

• Presence of beards

• Patient reported diagnosis of claustrophobia

• Non-English speaking

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Exercise Prescription
In this prospective, randomized control trial, the investigators will compare functional exercise capacity, cognitive performance, and emotional well-being at baseline and following 2 conditions: (1) an 8-week exercise training program (intervention) or (2) no training program (control). Participants will be randomized using a 1:1 randomization scheme into either the intervention or control group. After 8 weeks, participants in the wait-list control group will begin the intervention for the next 8 weeks and activity undergone by participants first randomized into the intervention group will remain under observation.

Locations

Country	Name	City	State
United States	Baylor Scott and White Sports Therapy and Research	Frisco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Sports Academy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen Consumption (VO2max), mL/min	Peak oxygen consumption (VO2max) is an indicator of health and fitness. Participants will perform a cardiopulmonary exercise test (CPET) while a metabolic cart measures and calculates their VO2max.	At first assessment, during week 1.
Primary	Peak Oxygen Consumption (VO2max), mL/min	Peak oxygen consumption (VO2max) is an indicator of health and fitness. Participants will perform a cardiopulmonary exercise test (CPET) while a metabolic cart measures and calculates their VO2max.	At second assessment, during week 11.
Primary	Peak Oxygen Consumption (VO2max), mL/min	Peak oxygen consumption (VO2max) is an indicator of health and fitness. Participants will perform a cardiopulmonary exercise test (CPET) while a metabolic cart measures and calculates their VO2max.	At third assessment, during week 20.
Primary	Score on Cognitive Function Self-Assessment Scale (CFSS)	The Cognitive Function Self-Assessment Scale (CFSS) is an 18-item questionnaire designed to self-assess cognitive function. Each question uses a 5-point Likert scale ranging from "never" (0) to "always" (5). The total score is calculated from the mean of the numbers with a lower values indicating a better self-perception of cognitive function and higher values indicating a worse self-perception of cognitive function.	At first assessment, during week 1.
Primary	Score on Cognitive Function Self-Assessment Scale (CFSS)	The Cognitive Function Self-Assessment Scale (CFSS) is an 18-item questionnaire designed to self-assess cognitive function. Each question uses a 5-point Likert scale ranging from "never" (0) to "always" (5). The total score is calculated from the mean of the numbers with a lower values indicating a better self-perception of cognitive function and higher values indicating a worse self-perception of cognitive function.	At second assessment, during week 11.
Primary	Score on Cognitive Function Self-Assessment Scale (CFSS)	The Cognitive Function Self-Assessment Scale (CFSS) is an 18-item questionnaire designed to self-assess cognitive function. Each question uses a 5-point Likert scale ranging from "never" (0) to "always" (5). The total score is calculated from the mean of the numbers with a lower values indicating a better self-perception of cognitive function and higher values indicating a worse self-perception of cognitive function.	At third assessment, during week 20.
Primary	Score on PHQ-8	The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.	At first assessment, during week 1.
Primary	Score on PHQ-8	The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point Likert scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.	At second assessment, during week 11.
Primary	Score on PHQ-8	The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point Likert scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.	At third assessment, during week 20.
Secondary	Duration, mm:ss	Total time of test (CPET).	At first assessment, during week 1.
Secondary	Duration, mm:ss	Total time of test (CPET).	At second assessment, during week 11.
Secondary	Duration, mm:ss	Total time of test (CPET).	At third assessment, during week 20.
Secondary	Peak VO2 (absolute), mL/min	Using metabolic cart, absolute peak oxygen consumption will be recorded.	At first assessment, during week 1.
Secondary	Peak VO2 (absolute), mL/min	Using metabolic cart, absolute peak oxygen consumption will be recorded.	At second assessment, during week 11.
Secondary	Peak VO2 (absolute), mL/min	Using metabolic cart, absolute peak oxygen consumption will be recorded.	At third assessment, during week 20.
Secondary	Peak VO2 (relative), mL/kg/min	Using metabolic cart, relative peak oxygen consumption will be recorded.	At first assessment, during week 1.
Secondary	Peak VO2 (relative), mL/kg/min	Using metabolic cart, relative peak oxygen consumption will be recorded.	At second assessment, during week 11.
Secondary	Peak VO2 (relative), mL/kg/min	Using metabolic cart, relative peak oxygen consumption will be recorded.	At third assessment, during week 20.
Secondary	Metabolic Equivalents	Using metabolic cart, metabolic equivalents will be recorded.	At first assessment, during week 1.
Secondary	Metabolic Equivalents	Using metabolic cart, metabolic equivalents will be recorded.	At second assessment, during week 11.
Secondary	Metabolic Equivalents	Using metabolic cart, metabolic equivalents will be recorded.	At third assessment, during week 20.
Secondary	Respiratory Exchange Ratio	Using metabolic cart, respiratory exchange ratio will be recorded.	At first assessment, during week 1.
Secondary	Respiratory Exchange Ratio	Using metabolic cart, respiratory exchange ratio will be recorded.	At second assessment, during week 11.
Secondary	Respiratory Exchange Ratio	Using metabolic cart, respiratory exchange ratio will be recorded.	At third assessment, during week 20.
Secondary	VE/VCO2 slope	Using metabolic cart, VE/VCO2 slope will be recorded.	At first assessment, during week 1.
Secondary	VE/VCO2 slope	Using metabolic cart, VE/VCO2 slope will be recorded.	At second assessment, during week 11.
Secondary	VE/VCO2 slope	Using metabolic cart, VE/VCO2 slope will be recorded.	At third assessment, during week 20.
Secondary	Minute Ventilation, L/min	Using metabolic cart, minute ventilation will be recorded.	At first assessment, during week 1.
Secondary	Minute Ventilation, L/min	Using metabolic cart, minute ventilation will be recorded.	At second assessment, during week 11.
Secondary	Minute Ventilation, L/min	Using metabolic cart, minute ventilation will be recorded.	At third assessment, during week 20.
Secondary	Breathing Reserve, %	Using metabolic cart, breathing reserve will be recorded.	At first assessment, during week 1.
Secondary	Breathing Reserve, %	Using metabolic cart, breathing reserve will be recorded.	At second assessment, during week 11.
Secondary	Breathing Reserve, %	Using metabolic cart, breathing reserve will be recorded.	At third assessment, during week 20.
Secondary	Tidal Volume, L	Using metabolic cart, tidal volume will be recorded.	At first assessment, during week 1.
Secondary	Tidal Volume, L	Using metabolic cart, tidal volume will be recorded.	At second assessment, during week 11.
Secondary	Tidal Volume, L	Using metabolic cart, tidal volume will be recorded.	At third assessment, during week 20.
Secondary	Respiratory Frequency, /min	Using metabolic cart, respiratory frequency will be recorded.	At first assessment, during week 1.
Secondary	Respiratory Frequency, /min	Using metabolic cart, respiratory frequency will be recorded.	At second assessment, during week 11.
Secondary	Respiratory Frequency, /min	Using metabolic cart, respiratory frequency will be recorded.	At third assessment, during week 20.
Secondary	Heart Rate, bpm	Using metabolic cart, heart rate will be recorded.	At first assessment, during week 1.
Secondary	Heart Rate, bpm	Using metabolic cart, heart rate will be recorded.	At second assessment, during week 11.
Secondary	Heart Rate, bpm	Using metabolic cart, heart rate will be recorded.	At third assessment, during week 20.
Secondary	Heart Rate Reserve, bpm	Using metabolic cart, heart rate reserve will be recorded.	At first assessment, during week 1.
Secondary	Heart Rate Reserve, bpm	Using metabolic cart, heart rate reserve will be recorded.	At second assessment, during week 11.
Secondary	Heart Rate Reserve, bpm	Using metabolic cart, heart rate reserve will be recorded.	At third assessment, during week 20.
Secondary	Heart Rate Recovery at 1 min, bpm	Using metabolic cart, heart rate recovery at 1 minute will be recorded.	At first assessment, during week 1.
Secondary	Heart Rate Recovery at 1 min, bpm	Using metabolic cart, heart rate recovery at 1 minute will be recorded.	At second assessment, during week 11.
Secondary	Heart Rate Recovery at 1 min, bpm	Using metabolic cart, heart rate recovery at 1 minute will be recorded.	At third assessment, during week 20.
Secondary	VO2/Heart Rate, mL/beat	Using metabolic cart, VO2/heart rate will be recorded.	At first assessment, during week 1.
Secondary	VO2/Heart Rate, mL/beat	Using metabolic cart, VO2/heart rate will be recorded.	At second assessment, during week 11.
Secondary	VO2/Heart Rate, mL/beat	Using metabolic cart, VO2/heart rate will be recorded.	At third assessment, during week 20.
Secondary	VO2 at anaerobic threshold, mL/min	Using metabolic cart, VO2 at anaerobic threshold will be recorded.	At first assessment, during week 1.
Secondary	VO2 at anaerobic threshold, mL/min	Using metabolic cart, VO2 at anaerobic threshold will be recorded.	At second assessment, during week 11.
Secondary	VO2 at anaerobic threshold, mL/min	Using metabolic cart, VO2 at anaerobic threshold will be recorded.	At third assessment, during week 20.
Secondary	PetCO2, mmHg	Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.	At first assessment, during week 1.
Secondary	PetCO2, mmHg	Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.	At second assessment, during week 11.
Secondary	PetCO2, mmHg	Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.	At third assessment, during week 20.
Secondary	PetO2, mmHg	Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.	At first assessment, during week 1.
Secondary	PetO2, mmHg	Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.	At second assessment, during week 11.
Secondary	PetO2, mmHg	Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.	At third assessment, during week 20.
Secondary	VE/VCO2	Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.	At first assessment, during week 1.
Secondary	VE/VCO2	Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.	At second assessment, during week 11.
Secondary	VE/VCO2	Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.	At third assessment, during week 20.
Secondary	Self-Rated Perceived Exertion	The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.	At first assessment, during week 1.
Secondary	Self-Rated Perceived Exertion	The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.	At second assessment, during week 11.
Secondary	Self-Rated Perceived Exertion	The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.	At third assessment, during week 20.
Secondary	Self-Rated Dyspnea	The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.	At first assessment, during week 1.
Secondary	Self-Rated Dyspnea	The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.	At second assessment, during week 11.
Secondary	Self-Rated Dyspnea	The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.	At third assessment, during week 20.
Secondary	Pulse oximetry	Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.	At first assessment, during week 1.
Secondary	Pulse oximetry	Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.	At second assessment, during week 11.
Secondary	Pulse oximetry	Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.	At third assessment, during week 20.
Secondary	Rhythm on electrocardiogram	Using an electrocardiogram, heart rhythm will be recorded.	At first assessment, during week 1.
Secondary	Rhythm on electrocardiogram	Using an electrocardiogram, heart rhythm will be recorded.	At second assessment, during week 11.
Secondary	Rhythm on electrocardiogram	Using an electrocardiogram, heart rhythm will be recorded.	At third assessment, during week 20.
Secondary	Heart Rate Variability (HRV)	Using the WHOOP 4.0, heart rate variability (HRV) will be calculated and recorded. This will be continuously recorded for 26 weeks.	Lasting 26 weeks.
Secondary	Respiratory rate	Using the WHOOP 4.0, respiratory rate will be recorded. This will be continuously recorded for 26 weeks.	Lasting 26 weeks.
Secondary	Strain	Using the WHOOP 4.0, strain will be calculated and recorded. This will be continuously recorded for 26 weeks.	Lasting 26 weeks.
Secondary	Skin temperature, °F	Using the WHOOP 4.0, skin temperature will be recorded. This will be continuously recorded for 26 weeks.	Lasting 26 weeks.
Secondary	IPAQ	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.	At first assessment, during week 1.
Secondary	IPAQ	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.	At second assessment, during week 11.
Secondary	IPAQ	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.	At third assessment, during week 20.
Secondary	Motor Speed on CogPT app	Using the Sports Academy CogPT iPad application, motor speed will be recorded.	At first assessment, during week 1.
Secondary	Motor Speed on CogPT app	Using the Sports Academy CogPT iPad application, motor speed will be recorded.	At second assessment, during week 11.
Secondary	Motor Speed on CogPT app	Using the Sports Academy CogPT iPad application, motor speed will be recorded.	At third assessment, during week 20.
Secondary	Reaction Time on CogPT app	Using the Sports Academy CogPT iPad application, reaction time will be recorded.	At first assessment, during week 1.
Secondary	Reaction Time on CogPT app	Using the Sports Academy CogPT iPad application, reaction time will be recorded.	At second assessment, during week 11.
Secondary	Reaction Time on CogPT app	Using the Sports Academy CogPT iPad application, reaction time will be recorded.	At third assessment, during week 20.
Secondary	Reaction Time with No-Go on CogPT app	Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.	At first assessment, during week 1.
Secondary	Reaction Time with No-Go on CogPT app	Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.	At second assessment, during week 11.
Secondary	Reaction Time with No-Go on CogPT app	Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.	At third assessment, during week 20.
Secondary	Dexterity on CogPT app	Using the Sports Academy CogPT iPad application, dexterity will be recorded.	At first assessment, during week 1.
Secondary	Dexterity on CogPT app	Using the Sports Academy CogPT iPad application, dexterity will be recorded.	At second assessment, during week 11.
Secondary	Dexterity on CogPT app	Using the Sports Academy CogPT iPad application, dexterity will be recorded.	At third assessment, during week 20.
Secondary	Inhibition on CogPT app	Using the Sports Academy CogPT iPad application, inhibition will be recorded.	At first assessment, during week 1.
Secondary	Inhibition on CogPT app	Using the Sports Academy CogPT iPad application, inhibition will be recorded.	At second assessment, during week 11.
Secondary	Inhibition on CogPT app	Using the Sports Academy CogPT iPad application, inhibition will be recorded.	At third assessment, during week 20.
Secondary	Dual-Processing on CogPT app	Using the Sports Academy CogPT iPad application, dual-processing will be recorded.	At first assessment, during week 1.
Secondary	Dual-Processing on CogPT app	Using the Sports Academy CogPT application, dual-processing will be recorded.	At second assessment, during week 11.
Secondary	Dual-Processing on CogPT app	Using the Sports Academy CogPT iPad application, dual-processing will be recorded.	At third assessment, during week 20.
Secondary	Working Memory Capacity	Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.	At first assessment, during week 1.
Secondary	Working Memory Capacity	Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.	At second assessment, during week 11.
Secondary	Working Memory Capacity	Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.	At third assessment, during week 20.
Secondary	Sleep duration on WHOOP	Using the WHOOP 4.0, sleep duration will be recorded. This will be continuously recorded every night for 26 weeks.	Lasting 26 weeks.
Secondary	Sleep efficiency on WHOOP	Using the WHOOP 4.0, sleep efficiency will be recorded. This will be continuously recorded every night for 26 weeks.	Lasting 26 weeks.
Secondary	Sleep stage duration on WHOOP	Using the WHOOP 4.0, sleep stage duration will be recorded. This will be continuously recorded every night for 26 weeks.	Lasting 26 weeks.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.	At first assessment, during week 1.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.	At second assessment, during week 11.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.	At third assessment, during week 20.
Secondary	Health Related Quality of Life (EQ-5D)	Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.	At first assessment, during week 1.
Secondary	Health Related Quality of Life (EQ-5D)	Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.	At second assessment, during week 11.
Secondary	Health Related Quality of Life (EQ-5D)	Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.	At third assessment, during week 20.
Secondary	Anxiety (GAD-7)	Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.	At first assessment, during week 1.
Secondary	Anxiety (GAD-7)	Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.	At second assessment, during week 11.
Secondary	Anxiety (GAD-7)	Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.	At third assessment, during week 20.
Secondary	PTSD (LEC-5 and PCL-5)	Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.	At first assessment, during week 1.
Secondary	PTSD (LEC-5 and PCL-5)	Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.	At second assessment, during week 11.
Secondary	PTSD (LEC-5 and PCL-5)	Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.	At third assessment, during week 20.
Secondary	Breathlessness (mMRC)	Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.	At first assessment, during week 1.
Secondary	Breathlessness (mMRC)	Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.	At second assessment, during week 11.
Secondary	Breathlessness (mMRC)	Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.	At third assessment, during week 20.
Secondary	Posttraumatic growth (PTGI)	Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.	At first assessment, during week 1.
Secondary	Posttraumatic growth (PTGI)	Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.	At second assessment, during week 11.
Secondary	Posttraumatic growth (PTGI)	Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.	At third assessment, during week 20.