The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID-19

University of Washington

Status: Completed

Conditions: Post COVID-19 Condition; Post-COVID-19 Syndrome

Treatments: Behavioral: 6-Week Self-Management Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05658536

STUDY00016345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

6-Week Self-Management Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: 6-Week Self-Management Group

6-Week Waitlist Group

No Intervention group

Description:

6-week waitlist period during which participants will complete study assessments. After completing the study, waitlist participants will be offered the active intervention.