Self-Management Interventions for Long COVID-19
ConditionCOVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorToronto Rehabilitation Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically diagnosed Long-COVID plus PCR positivity with and without hospitalization
3-12 months post-diagnosis of COVID-19
>2 self-reported persisting symptoms in >1 mood, cognitive and/or somatic symptom domain
Age >18
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Education and Strategies Intervention
BehavioralSessions 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.
Mindfulness Skills Intervention
BehavioralThe 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.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Education and Strategies Intervention GroupExperimental treatment 1 intervention
Group B: Mindfulness Skills Intervention GroupActive comparator 1 intervention
Group C: No-Treatment Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 1-week post-intervention.2
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.
Time frame
Baseline and 1-week post-intervention.3
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.
Time frame
Baseline and 1-week post-intervention.4
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.
Time frame
Baseline and 1-week post-intervention.Secondary outcomes
1
Feasibility: session feedback questionnaire
Designed by our team, this session feedback questionnaires includes 3 questions asking the participant how useful and applicable they found the content taught during intervention sessions. Participants answer on a likert scale ranging from 1="Not at all useful" to 5="Very useful". Higher score is desired.
Time frame
At the end of each weekly session for a duration of 8 weeks.2
Feasibility: Recruitment rate
Determined by dividing the number of patients consented by the number of eligible patients approached. Rate closer to 1 is desired.
Time frame
Collected during recruitment3
Feasibility: Retention rate
Determined by dividing the number of consented patients at baseline by the number of consented patients retained at follow-up. Factors influencing retention (e.g., medical status) will be reported as percentages. Rate closer to 1 is desired
Time frame
Collected during recruitment and 1 week post-follow-up4
Feasibility: Adherence rate
Determined by calculating the percentage of patients adhering to at least 80% of the training protocol. Compliance rates to be computed for individual participants weekly, and for full cohort at end of study. Rate closer to 100% is desired. Factors influencing recruitment, retention and completion will be documented and reported as percentages
Time frame
Collected during each of the 8 session (1 sessions/week, 8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Toronto Rehabilitation Institute
Lead sponsor
University Health Network, Toronto
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov