Narrative Intervention for Long COVID-19 (NICO)

Long COVID Clinical Trial

— NICO  

Official title:

Narrative Intervention for Long COVID-19 (NICO) Research Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06091293
• Other study ID #: 22-0701
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

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