Clinical trial NCT05658536: The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID-19
Official title: The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19 Condition
Post-COVID-19 Syndrome
Keywords: Post-COVID-19
Self-management
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intervention Acceptability
timeFrame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
measure: Intervention Appropriateness
timeFrame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
measure: Intervention Feasibility
timeFrame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Anxiety Symptoms
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Fatigue
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Sleep Disturbance
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Perceived Cognitive Difficulties
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Self-Efficacy
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Psychosocial Functioning
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Pain Interference
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
measure: Impression of Change
timeFrame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
measure: Symptoms and Impact of Post-COVID
timeFrame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Ninth and Jefferson Building
state: Washington
Study officials:
affiliation: University of Washington
name: Tracy Herring, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Lindsey Knowles, PhD
role: PRINCIPAL_INVESTIGATOR
References: