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

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

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

Study Overview

• Status: Completed
• Conditions: Long COVID; Long Covid19
• Intervention / Treatment: Behavioral: Narrative Intervention for Long COVID-19 (NICO)

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NICO; The NICO intervention includes components of narrative-informed interventions, brief solution-focused therapy, and medical social work case management to examine adjustment to illness for people living with Long COVID.	Behavioral: Narrative Intervention for Long COVID-19 (NICO); The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Health Questionnarrie- 8 item (PHQ8)	Measurement of depression widely used in clinical and research settings	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder- 7 item (GAD7)	Measurement of anxiety widely used in clinical and research settings	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Rachel Johnson, PhD, LCSW, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 22-0701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No