## Protocol Section
### Identification Module
**NCT ID:** NCT05566379

**Brief Title:** Mindfulness in Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia

**Official Title:** Effects of a Mindfulness Intervention on Physical and Psychological Well-Being and Quality of Life in Patients With Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia

#### Organization Study ID Info
**ID:** 22-001020
#### Organization
**Class:** OTHER
**Full Name:** University of California, Los Angeles
### Status Module
#### Completion Date
**Date:** 2023-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-10

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-02-28

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2022-10-04
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-02
**Study First Submit QC Date:** 2022-10-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Los Angeles

#### Responsible Party

**Investigator Affiliation:** University of California, Los Angeles

**Investigator Full Name:** Jeffrey J. Hsu

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The current pilot study will recruit participants experiencing new, returning, or ongoing symptoms related to COVID-19 illness for at least four weeks after being first infected with SARS-CoV-2. All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center (MARC) at University of California Los Angeles (UCLA). This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. The research team will collect self-reported measures of mental health symptoms, physical health symptoms, and demographic information before and after participants attend MAPs. Objective health measures will also be collected by the research team including an active stand test, a 6-minute walk, and a blood sample.

**Detailed Description:** The purpose of the current pilot project is to assess the feasibility and effects of a 6-week group mindfulness intervention in patients with Post Acute Sequelae of SARS-CoV-2 Infection (PASC)-related dysautonomia.

This single-arm study uses a one group pretest/posttest design. A convenience sample of patients will be recruited from the Ahmanson-University of California Los Angeles (UCLA) COVID-19 Cardiology Specialty Clinic and UCLA Long COVID Program.

Outcomes Measures:

Once consented, eligible participants will complete a baseline demographics survey, preintervention assessments including the composite autonomic symptom scoring (COMPASS-31), outcome measures questionnaires for perceived stress, anxiety, depression, fatigue, resilience, sleep, event specific distress, well-being and quality of life. A peripheral blood collection device for evaluation of inflammatory gene expression will be performed along with an active stand test and 6- minute walk prior to the mindfulness intervention. The same measures will be collected following completion of the intervention. Additionally, a logbook of patient self-reported practice frequency will be reviewed, and a focused 3 question audio recorded interview will be conducted at the post intervention visit. At 4-week follow-up post intervention, the final set of assessment questionnaires, and a 3-question mindfulness experience survey will be collected.

Intervention:

Participants will complete a virtual group based 6-week mindfulness meditation-based intervention, Mindful Awareness Practices (MAPs), developed by Diana Winston and colleagues at the Mindful Awareness Research Center (MARC) at UCLA. In response to COVID-19 precautions participants will meet virtually for six weekly, 2-hour group sessions. The group size is estimated at 15 participants.

MAPs is a standardized intervention that has been used in several previous studies. MAPS includes presentation of theoretical framework and materials on mindfulness, relaxation, and the mind-body connection, and experiential practice of meditation. Lecture, discussion, and group process focus on solving problems concerning barriers to effective practice, working with difficult thoughts and emotions, managing pain, and cultivation of loving kindness. Written materials are provided with a summary of information covered each week. Additionally, participants are instructed to practice mindfulness exercises at home on a daily basis (5-20 minutes/day) and advised in the informal use of mindfulness in daily life. Participants will be asked to keep a self-reported log of their daily practice. Classes will be led by experienced mindfulness instructors who received specialized training at the UCLA MARC Center.

Overview:

Baseline Visit (in person): collect within 1-2 week(s) prior to the intervention.

Consent Baseline demographics survey COMPASS-31: the composite autonomic symptom score Questionnaires: perceived stress (PSS), anxiety (GAD-7), depression (PHQ 8), event specific distress (IES-R), fatigue (FSI), sleep (ISI), well-being (MHC-SF), resilience (CD-RISC10), QOL (SF-20).

Tasso device blood collection for evaluation of inflammatory gene expression. Perform an active stand test Perform 6-minute walk

Post Intervention Visit (in person): collect within 1-2 weeks post intervention completion COMPASS-31: the composite autonomic symptom score Questionnaires: perceived stress (PSS), anxiety (GAD-7), depression (PHQ 8), event specific distress (IES-R), fatigue (FSI), sleep (ISI), well-being (MHC-SF), resilience (CD-RISC10), QOL (SF-20).

Tasso device blood collection for evaluation of inflammatory gene expression Perform an active stand test Perform Six-minute walk Three question mindfulness experience focused interview Frequency of Practice Logbook review

4-Week Post Intervention Visit (remote link / in person NOT required): collect 4 weeks (+2) post intervention Questionnaires: perceived stress (PSS), anxiety (GAD-7), depression (PHQ 8), event specific distress (IES-R), fatigue (FSI), sleep (ISI), well-being (MHC-SF), resilience (CD-RISC10), QOL (SF-20). 3-question Likert mindfulness experience survey

### Conditions Module

**Conditions:**

- Long COVID

- Dysautonomia

**Keywords:**

- Mindfulness , Long COVID, Dysautonomia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center at UCLA. Participants will learn Mindful concepts and a variety of Mindfulness practices. This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. MAPs classes meets weekly for two hours per week for six weeks. Participants are encouraged to complete some daily meditation practice starting at five minutes a day and working up to 20 minutes daily by the end of the course.

**Intervention Names:**

- Other: Mindfulness - Mindful Awareness Practices ( MAPs)

**Label:** Mindfulness Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mindfulness Intervention

**Description:** All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center at UCLA. Participants will learn Mindful concepts and a variety of Mindfulness practices. This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. MAPs classes meets weekly for two hours per week for six weeks. Participants are encouraged to complete some daily meditation practice starting at five minutes a day and working up to 20 minutes daily by the end of the course.

**Name:** Mindfulness - Mindful Awareness Practices ( MAPs)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The six domain scores sum to a total score of 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.

**Measure:** Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)

**Description:** Active Stand Test. Clinically, an active stand test can be used to assess short-term neural and cardiovascular function and identify the hemodynamic correlates of patient symptoms and attributable causes of (pre-)syncope, and to detect autonomic dysfunction, variants of orthostatic hypotension, postural orthostatic tachycardia syndrome and orthostatic hypertension. During a standardized active stand test procedure, heart rate and blood pressure are measured after resting lying down, then immediately upon standing and after 2, 5 and 10 minutes.

**Measure:** Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance.

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)

**Description:** Six Minute Walk. The six-minute walk (6MWT) was developed in 1963 by Balke to evaluate functional capacity and endurance during physical activity. The standardized six-minute walk test (6MWT) measures the maximum distance an individual is able to walk over a total of six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a flat marked walkway. Baseline heart rate and oxygen saturation are measured then continuously monitored to identify the lowest oxygen saturation, which may occur before the end of the test. The patient's baseline and post-test perceived dyspnea and fatigue are rated using the Borg scale 0-10 (0 none- 10 maximum).

**Measure:** Change from baseline of Six Minute Walk in hemodynamic parameters, exercise tolerance

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)

**Description:** Self-reported QOL SF-20. A 20-item questionnaire. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).

Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. Raw scores are transformed to fit the 0% to 100% interval as described in the original publication (note that for question #1 on general health, an initial transformation is performed as follows: 1 = 5, 2 = 4.36, 3 = 3.43, 4 = 1.99, 5 = 1). Reversal of scoring is completed as necessary such that the highest score always represents the best possible score. The exception to this scoring pattern is the pain score, for which 0% represents the best possible score and 100% the worst possible score.

**Measure:** Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

#### Secondary Outcomes

**Description:** Perceived Stress Scale (PSS) appraises thoughts and feelings in perception of stress. It is a 10-item scale (score 0-40) with upper scores signifying increased perceived stress. While the aim is to capture stress level, the PSS is used to obtain a patients' perceptions of their own stress.

**Measure:** Change from baseline in mean scores of PSS- Perceived Stress Scale.

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** Generalized Anxiety Disorder (GAD7) It is a 7-item scale (score 0-21), with acuity distinguished as mild (5-9), moderate (10-14) or severe (15-21) distress (Spitzer et al. 2006). The higher score indicates greater anxiety.

**Measure:** Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** Depression (PHQ8) adapted from the PHQ-9, is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. A PHQ-8 score of 0 to 4 indicates no depression, of 5 to 9 indicates mild depression, of 10 to 14 indicates moderate depression, of 15 to 19 indicates moderately severe depression, and of 20 or higher indicates severe depression.

**Measure:** Change from baseline in mean scores of PHQ-8 - Depressive Symptoms

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** Impact of Event Scale -Revised (IES-R). is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of PTSD. Respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.

**Measure:** Change from baseline in mean scores of IES-R - event-related distress scale

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** The Fatigue Symptom Inventory (FSI) is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life in the past week. Severity is measured on point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured by the number of days (0-7) that respondents felt fatigued and the extent of each day they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue was felt to interfere with with general level of activity, enjoyment, and mood.

**Measure:** Change from baseline in mean scores of FSI - The Fatigue Symptom Inventory.

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** The Insomnia Severity Index (ISI) is a seven-item self-report questionnaire, which asks respondents to rate the nature and symptoms of their sleep problems. Dimensions evaluated are severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

**Measure:** Change from baseline in mean scores of the ISI - The Insomnia Severity Index

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** The Mental Health Continuum Short Form (MHC-SF) is a 14- item scale containing 3 items for emotional (hedonic) well-being, 5 items for social well-being, and 6 items for psychological well-being (eudaimonic). Each of the items can be scored between 0 and 5, with the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. This scale also provides a flourishing and languishing mental health indicator based on these three subscales.

**Measure:** Change from baseline in mean scores of well-being from MHC-SF-The Mental Health Continuum Short Form

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

**Description:** Connor Davidson Resilience Scale (CD-RISC 10) is a 10-item scale (score 0-40) that measures components of adaptation, coping and recovery in response to stressful events, trauma, or tragedy. The higher scores reflect greater resilience.

**Measure:** Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale.

**Time Frame:** Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Adult females (18 years - 54 years of age)

* Previous SARS-CoV-2 infection confirmed by Polymerase chain reaction (PCR) testing and diagnoses of PASC and dysautonomia confirmed by objective testing (e.g., autonomic reflex screen, active stand test)
* Ability to comprehend English and complete assessments and patient-reported surveys
* Availability of a smartphone, tablet, or computer with Internet access

Exclusion Criteria:

* Inability to participate in the virtual intervention or complete outcomes surveys

  * Current participation regular mindfulness practice
  * Current enrollment in another COVID-19 related study.

**Maximum Age:** 54 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** evandenbogaart@mednet.ucla.edu

**Name:** Elizabeth Vandenbogaart, DNP MSN ACNP

**Phone:** 310 825 8816

**Phone Ext:** 2

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** evandenbogaart@mednet.ucla.edu

- **Name:** Elizabeth Vandenbogaart, DNP MSN ACNP

- **Phone:** 310-825-8816

- **Phone Ext:** 2

- **Role:** CONTACT

**Country:** United States

**Facility:** UCLA Health

**State:** California

**Status:** RECRUITING

**Zip:** 90095

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Los Angeles

**Name:** Jeffrey J. Hsu, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000094025

- Term: Post-Infectious Disorders

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: SARS-CoV-2 Infection

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3013

- Name: Post-Acute COVID-19 Syndrome

- Relevance: HIGH

- As Found: Post-Acute Sequelae of SARS-CoV-2 Infection

- ID: M4643

- Name: Autonomic Nervous System Diseases

- Relevance: HIGH

- As Found: Dysautonomia

- ID: M27979

- Name: Primary Dysautonomias

- Relevance: HIGH

- As Found: Dysautonomia

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3014

- Name: Post-Infectious Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000094024

- Term: Post-Acute COVID-19 Syndrome

- ID: D000001342

- Term: Autonomic Nervous System Diseases

- ID: D000054969

- Term: Primary Dysautonomias

### Misc Info Module

- Version Holder: 2024-05-24
