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

Primary Purpose

Long COVID, Long Covid19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative Intervention for Long COVID-19 (NICO)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Long COVID

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Long COVID Have access to email weekly Between the ages of 18-89 years old Exclusion Criteria: Conflicting research study

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NICO

Arm Description

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.

Outcomes

Primary Outcome Measures

Personal Health Questionnarrie- 8 item (PHQ8)
Measurement of depression widely used in clinical and research settings

Secondary Outcome Measures

Generalized Anxiety Disorder- 7 item (GAD7)
Measurement of anxiety widely used in clinical and research settings

Full Information

First Posted
October 18, 2023
Last Updated
October 19, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT06091293
Brief Title
Narrative Intervention for Long COVID-19 (NICO)
Acronym
NICO
Official Title
Narrative Intervention for Long COVID-19 (NICO) Research Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
February 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID, Long Covid19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study has one arm. All participants will receive the NICO intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NICO
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Narrative Intervention for Long COVID-19 (NICO)
Intervention Description
The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period.
Primary Outcome Measure Information:
Title
Personal Health Questionnarrie- 8 item (PHQ8)
Description
Measurement of depression widely used in clinical and research settings
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder- 7 item (GAD7)
Description
Measurement of anxiety widely used in clinical and research settings
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Long COVID Have access to email weekly Between the ages of 18-89 years old Exclusion Criteria: Conflicting research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Johnson, PhD, LCSW
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Narrative Intervention for Long COVID-19 (NICO)

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