Self-Management Interventions for Long COVID-19

NCT05268523 | Recruiting

• 1 other identifier: 21-5038
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate and compare the feasibility and efficacy of two group-based interventions (education vs. mindfulness) to help self-manage Long-COVID symptoms.

Conditions

COVID-19

Keywords

Long-term effects; Self-management; Group therapy; Telerehabilitation

Outcome Measures

Primary Outcomes (10)

• Change in Brief-COPE

  The Brief-COPE (Coping Orientation to Problems Experienced Inventory) is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Total scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style (scores ranging from 1-4, where the higher the score, the better the coping ability). Increase in score is the better outcome, indicating improved coping ability.

  Baseline and 1-week post-intervention.

• Change in LOT

  The Life Orientation Test (LOT) is a 10-item scale that assesses one's dispositional level of optimism, coping and resilience. Respondents use a 5-point rating scale (0 = strongly disagree; 4 = strongly agree) to show how much they agree with 10 statements about positive and negative expectations. All scores are summed to obtain a total score from 0-24 with higher ratings meaning more optimism. Increase in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in Kessler Psychological Distress Scale (K10)

  This is a 10-item questionnaire measuring level of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Participant answer experiencing each feeling from 'none of the time' (score=1) to 'all of the time' (score=5). Scores of the 10 items summed to produce a total score between 10 and 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. Decrease in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in SSS-8

  The Somatic Symptom Scale - 8 (SSS-8) is a brief, 8-item self-report questionnaire used to assess somatic symptom burden. Participants rate how often they experience somatic symptoms (e.g. back pain, dizziness, headaches) on a scale from 0 (Not at all to) to 4 (Very much). Scores are summed to obtain total score between 0 and 32, the higher the score, the higher the somatic symptom burden. Decrease in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in Perceived Medical Condition Self-Management Scale

  The Perceived Medical Condition Self-Management Scale (PMCSMS) evaluates self-measured ability to manage a chronic health condition (Long COVID). Participants answer the 8 questions using a scale from 1-5, with 1 signifying "strongly disagree" and 5 signifying "strongly agree". All scores are summed to obtain a total score from 8-401 with higher ratings meaning better management. Increase in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in the Depression, Anxiety and Stress Scale

  The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) measures the emotional states of depression, anxiety and stress. Participants rate 21 emotional states on a scale of 0-3 to indicate how much the statement applied to them over the past week, with 0=never, to 3=almost always. Scores are summed to obtain total scores for each Depression, Anxiety and Stress category ranging between 0 and 21, the higher the score, the more severe the symptoms. Decrease in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in Quality of Life Enjoyment and Satisfaction Questionnaire

  TheQuality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The higher the score, the better the life enjoyment and satisfaction. Increase in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in Adapted Illness Intrusiveness Rating

  The Adapted Illness Intrusiveness Rating (AIIR) measures intrusiveness of symptoms in daily life. 13 items ask about how much Long-COVID and/or its treatment interferes with daily life on a scale of 1=not at all, to 7=very much. Scores are summed for domains of Physical Well-Being and Diet, Work and Finances, Marital, Sexual, and Family Relations, Recreation and Social Relations Items, Other Aspects of Life. The higher the total scores, the more intrusive the illness. Decrease in score is the better outcome.

  Baseline and 1-week post-intervention.

• Change in self-reported physician visits

  Participants will report how many times they have visited a physician during the past month. Answers will range from 0 to 10 or more. Reduction in the number of physician visits is the desired outcome.

  Baseline and 1-week post-intervention.

• Change in Self-efficacy

  The Self-Efficacy (Ages 18+) - Item Bank/Fixed Form is part of the measures in NIH Toolbox that measures self-efficacy, or the capacity to manage functioning and have control over meaningful events. Participants rate how often they experience events on a scale of 1=never to 4=very often. Items are summed to obtain total score. The higher the number, the higher their self-efficacy. Increase in score is the better outcome

  Baseline and 1-week post-intervention.

Secondary Outcomes (5)

• Feasibility: session feedback questionnaire

  At the end of each weekly session for a duration of 8 weeks.

• Feasibility: Recruitment rate

  Collected during recruitment

• Feasibility: Retention rate

  Collected during recruitment and 1 week post-follow-up

• Feasibility: Adherence rate

  Collected during each of the 8 session (1 sessions/week, 8 weeks)

• Feasibility: qualitative interview

  1 week post-intervention

Study Arms (3)

Education and Strategies Intervention Group

EXPERIMENTAL

Participants will use a videoconferencing system to participate in the Education and Strategies Intervention composed of 1 session per week (1.5 hrs/session) over the course of 8 weeks.

Behavioral: Education and Strategies Intervention

Mindfulness Skills Intervention Group

ACTIVE COMPARATOR

Participants will use a videoconferencing system to participate in the Mindfulness Skills Intervention composed of 1 session per week (1.5 hrs/session) over the course of 8 weeks.

Behavioral: Mindfulness Skills Intervention

No-Treatment Control Group

NO INTERVENTION

Participants adhere to the standard of care (no study treatment) for 8 weeks.

Interventions

Education and Strategies Intervention BEHAVIORAL

Sessions will be led by registered therapists and clinicians in the fields of psychology, rheumatology, cardiology and neurology. The sessions will be comprised of educational presentations on the nature of persisting symptoms after COVID-19 and associated recommendations for self-management.

Education and Strategies Intervention Group

Mindfulness Skills Intervention BEHAVIORAL

The Mindfulness Skills Intervention is an 8-week program designed to provide an introduction to some basic mindfulness skills. Each session begins with a brief breath focus practice followed by discussion of the experience and sharing/discussion of the previous week including participants' experiences. Each session also includes some didactics, and a new, related mindfulness skill is introduced and practiced, followed by another discussion.

Mindfulness Skills Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed Long-COVID plus PCR positivity with and without hospitalization
• months post-diagnosis of COVID-19
• \>2 self-reported persisting symptoms in \>1 mood, cognitive and/or somatic symptom domain
• Age \>18
• English speaking
• Private access to computer/internet

You may not qualify if:

• Acute ventilator support
• Diagnosed dementia
• Past/present history of psychotic illness or mania and, because of potential overlap in symptoms, diagnosis of chronic fatigue syndrome, fibromyalgia, chronic lyme disease or traumatic brain injury
• Long-COVID symptom severity (i.e., physical, cognitive, emotional symptoms) at a level that would significantly interfere with attendance/adherence to the intervention protocol

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• University Health Network, Toronto: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

RECRUITING

Related Publications (6)

• Gorna R, MacDermott N, Rayner C, O'Hara M, Evans S, Agyen L, Nutland W, Rogers N, Hastie C. Long COVID guidelines need to reflect lived experience. Lancet. 2021 Feb 6;397(10273):455-457. doi: 10.1016/S0140-6736(20)32705-7. Epub 2020 Dec 23. No abstract available.

  PMID: 33357467 BACKGROUND

• Mahase E. Covid-19: What do we know about "long covid"? BMJ. 2020 Jul 14;370:m2815. doi: 10.1136/bmj.m2815. No abstract available.

  PMID: 32665317 BACKGROUND

• Sykes DL, Holdsworth L, Jawad N, Gunasekera P, Morice AH, Crooks MG. Post-COVID-19 Symptom Burden: What is Long-COVID and How Should We Manage It? Lung. 2021 Apr;199(2):113-119. doi: 10.1007/s00408-021-00423-z. Epub 2021 Feb 11.

  PMID: 33569660 BACKGROUND

• Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6.

  PMID: 33836148 BACKGROUND

• Bryson WJ. Long-term health-related quality of life concerns related to the COVID-19 pandemic: a call to action. Qual Life Res. 2021 Mar;30(3):643-645. doi: 10.1007/s11136-020-02677-1. Epub 2020 Oct 18.

  PMID: 33073307 BACKGROUND

• Rybkina J, Jacob N, Colella B, Gold D, Stewart DE, Ruttan LA, Meusel LC, McAndrews MP, Abbey S, Green R. Self-managing symptoms of Long COVID: an education and strategies research protocol. Front Public Health. 2024 Feb 7;12:1106578. doi: 10.3389/fpubh.2024.1106578. eCollection 2024.

  PMID: 38384879 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Robin Green, PhD

  KITE- Toronto Rehabilitation Institute, University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Rybkina, MSc

CONTACT

416-597-3422; julia.rybkina@uhn.ca

Nithin Jacob, MSc

CONTACT

416-597-3422; helpscovid@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Single-Centre, multi-arm, pragmatic RCT

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 7, 2022
• Study Start: November 23, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CA (1)