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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06091293
Other study ID # 22-0701
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 11, 2022
Est. completion date February 8, 2024

Study information

Verified date October 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention.


Description:

People living with COVID19 Long Haul Syndrome frequently experience high symptom burden and problems performing basic activities of daily living. COVID19 has impacted mental health not only for people directly affected by the pandemic, including people who are living with COVID19 Long Haul Syndrome, but also those affected indirectly, putting further strain on the mental health system, which was already under stress. Understanding the experience of COVID 19 Long Haul Syndrome that can inform innovative and impactful ways to improve living with COVID19. Mental health providers are in high demand with an increase in burnout. One study reported 1/3 of mental health providers have experienced severe burnout since the onset of the pandemic. There are nursing staff shortages across the US, especially in rural areas. Shortages also occur within social work staff globally. There is a need to design innovative, interdisciplinary, and less time-intensive interventions to help those living with chronic illness. More people living longer with different types of illnesses and staffing shortages make traditional talk therapy interventions more challenging to deliver to more people. This study has two specific aims: Aim 1: Establish the acceptability and feasibility of an asynchronous narrative intervention for people living with long haul COVID19. Aim 2: Explore themes of illness narratives of people living with long haul COVID19


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date February 8, 2024
Est. primary completion date February 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Diagnosed with Long COVID - Have access to email weekly - Between the ages of 18-89 years old Exclusion Criteria: - Conflicting research study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Narrative Intervention for Long COVID-19 (NICO)
The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period.

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personal Health Questionnarrie- 8 item (PHQ8) Measurement of depression widely used in clinical and research settings Baseline and 3 months
Secondary Generalized Anxiety Disorder- 7 item (GAD7) Measurement of anxiety widely used in clinical and research settings Baseline and 3 months
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