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Purpose

This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥ 18 years 2. Resident of Washington state 3. Diagnosis of a Post-COVID condition 4. Able to read, speak, and understand English 5. Availability of a telephone and internet access

Exclusion Criteria

  1. Severe cognitive impairment 2. Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A randomized, 2-group parallel design, 50-subject pilot clinical trial to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
6-Week Self-Management Group 		6-week telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID. The intervention consists of six weekly group sessions that are 1.5 hours long. Group size is 8-10 participants.
  • Behavioral: 6-Week Self-Management Group
    The goal of the 6-session group-based intervention for patients with Post-COVID is to teach patients behavioral strategies known to be helpful in managing several common Post-COVID symptoms, including fatigue, memory and attention issues, poor sleep, breathlessness, coping with anxiety and uncertainty, and stress management. It is currently available to patients who are seen in the Post-COVID-19 Rehabilitation and Recovery Clinic at UW and the Post-COVID-19 Clinic in VAPSHCS Rehabilitation Care Services.
No Intervention
6-Week Waitlist Group 		6-week waitlist period during which participants will complete study assessments. After completing the study, waitlist participants will be offered the active intervention.

Recruiting Locations

More Details

NCT ID
NCT05658536
Status
Completed
Sponsor
University of Washington

Detailed Description

Post-acute sequelae SARS-CoV-2 infection (PASC), also referred to as Post-COVID, is an emerging condition with debilitating symptoms relevant to rehabilitation medicine. Post-COVID has been described as the "next national health disaster". The Centers for Disease Control and Prevention describe Post COVID as a wide range of physical and mental health symptoms lasting four or more weeks after SARS-CoV-2 infection. Some of the most common and disabling symptoms include, fatigue, memory issues, pain-related symptoms, insomnia, and shortness of breath. In addition to these physical symptoms, many patients with Post-COVID report co-occurring mental health concerns, including anxiety and depression. It is believed that over 100 million people worldwide currently experience or have experienced Post COVID. Importantly, this condition can be debilitating and disabling - nearly one in five people reported not working as a direct result of Post COVID. Psychosocial self-management interventions are a promising treatment for helping people with Post COVID manage their symptoms and engage in adaptive coping. Unfortunately, there is currently no cure for Post COVID, and it is unclear at what timepoint patients will recover or what proportion of patients will recover. Given the variability and chronicity of Post COVID symptoms, self-management interventions could be particularly beneficial. Research on patient populations with similar symptom profiles as Post COVID (e.g., myalgic encephalomyelitis, multiple sclerosis) suggests that psychosocial interventions like self-management can reduce symptom severity and interference and improve coping. This randomized controlled pilot trial will use quantitative and qualitative methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID. The study objectives include: 1. To examine the feasibility and acceptability of a telemedicine group-based intervention for improving symptom management and coping in adults with Post-COVID. 2. To examine initial effects of a telemedicine group-based intervention on Post-COVID symptom management and adaptive coping. 3. To understand intervention participants' perceptions of the feasibility, acceptability, appropriateness, and perceived effectiveness of the Post-COVID intervention and their recommendations for improving the intervention.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.