NCT06091293

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

October 18, 2023

Last Update Submit

December 5, 2024

Conditions

Long COVIDLong Covid19

Outcome Measures

Primary Outcomes (1)

  • Personal Health Questionnarrie- 8 item (PHQ8)

    Measurement of depression widely used in clinical and research settings

    Baseline and 3 months

Secondary Outcomes (1)

  • Generalized Anxiety Disorder- 7 item (GAD7)

    Baseline and 3 months

Study Arms (1)

NICO

EXPERIMENTAL

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)

Interventions

Narrative Intervention for Long COVID-19 (NICO)BEHAVIORAL

The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period.

NICO

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Long COVID
  • Have access to email weekly
  • Between the ages of 18-89 years old

You may not qualify if:

  • Conflicting research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rachel Johnson, PhD, LCSW

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study has one arm. All participants will receive the NICO intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 19, 2023

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)