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临床试验/NCT05268523
NCT05268523招募中不适用

Interventions to Teach Self-management Skills for Persisting Symptoms of COVID-19: Minimizing Impact of Symptoms on Everyday Functioning and on Healthcare Usage/utilization

Toronto Rehabilitation Institute2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2021年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
2
主要终点
Change in self-reported physician visits

研究概览

简要总结

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.

详细描述

After a COVID-19 infection, more than 75% of patients report ongoing somatic, cognitive, and psychiatric symptoms. At this time, research is needed to help develop treatments that limit the impact of these symptoms on people who have had COVID-19. The present study investigates the feasibility and efficacy of two group-based interventions in a single-centre, 3-arm, pragmatic RCT comprising (i) an Education Intervention Group arm, (ii) a Mindfulness Skills Intervention Group arm, and (iii) a No-Treatment Control Group arm. Phase 1 is a pilot RCT and will employ a mixed methods design with qualitative post-treatment interviews in a subset of participants in the Education Intervention Group arm only. Phase 2 is a full-scale, quantitative-only RCT, with refinements and power analysis based on the results of Phase 1. Sessions of both groups are delivered by licensed therapists and clinicians. Sessions last 1.5 hours per week for 8 weeks, with 10-15 patients/group in an online format. The Education group participants will learn about the nature of Long-COVID symptoms and discuss strategies for self-care/self-management of symptoms in recovery. The Mindfulness Skills Intervention group participants will receive an introduction to some basic mindfulness skills and practice strategies such as Mindfulness of Breath, Body, Sounds, Thoughts, and Choiceless Awareness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • English speaking
  • Private access to computer/internet

排除标准

  • 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

结局指标

主要结局

Change in self-reported physician visits

时间窗: Baseline and 1-week post-intervention.

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.

Change in Kessler Psychological Distress Scale (K10)

时间窗: Baseline and 1-week post-intervention.

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.

Change in SSS-8

时间窗: Baseline and 1-week post-intervention.

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.

Change in Perceived Medical Condition Self-Management Scale

时间窗: Baseline and 1-week post-intervention.

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.

Change in Quality of Life Enjoyment and Satisfaction Questionnaire

时间窗: Baseline and 1-week post-intervention.

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.

Change in Adapted Illness Intrusiveness Rating

时间窗: Baseline and 1-week post-intervention.

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.

Change in Brief-COPE

时间窗: Baseline and 1-week post-intervention.

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.

Change in LOT

时间窗: Baseline and 1-week post-intervention.

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.

Change in the Depression, Anxiety and Stress Scale

时间窗: Baseline and 1-week post-intervention.

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.

Change in Self-efficacy

时间窗: Baseline and 1-week post-intervention.

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robin Green

Senior Scientist

Toronto Rehabilitation Institute

研究点 (2)

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