Long COVIDNICONCT06091293
Narrative Intervention for Long COVID-19 (NICO)
A study testing Narrative Intervention for Long COVID-19 (NICO) in people with Long COVID and Long Covid19, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Long COVID, Long Covid19
- What is being tested?
- Narrative Intervention for Long COVID-19 (NICO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Long COVID
- Have access to email weekly
- Between the ages of 18-89 years old
Who cannot join
- Conflicting research study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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
- Conditions
- Long COVID, Long Covid19
- Being tested
- Narrative Intervention for Long COVID-19 (NICO)
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Intervention for Long COVID-19 (NICO)Behavioural
The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Narrative Intervention for Long COVID-19 (NICO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Health Questionnarrie- 8 item (PHQ8)
Measurement of depression widely used in clinical and research settings
Measured: Baseline and 3 months
Secondary outcomes (1)
Generalized Anxiety Disorder- 7 item (GAD7)
Measurement of anxiety widely used in clinical and research settings
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Oct 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study has one arm. All participants will receive the NICO intervention.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Johnson, PhD, LCSW, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091293
- Sponsor's protocol ID
- 22-0701
- Acronym
- NICO
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Intervention for Long COVID-19 (NICO) Research Study
- ClinicalTrials.gov ID
- NCT06091293
- Acronym / sponsor ID
- NICO / 22-0701
- Conditions
- Long COVID, Long Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study has one arm. All participants will receive the NICO intervention.
| Arm | Type | Receives |
|---|---|---|
| NICO | Experimental | Behavioral: Narrative Intervention for Long COVID-19 (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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Long COVID
- Have access to email weekly
- Between the ages of 18-89 years old
Key exclusion criteria (1 listed)
- Conflicting research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Intervention for Long COVID-19 (NICO)The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period. | Behavioural | NICO |
Primary outcome
Personal Health Questionnarrie- 8 item (PHQ8)
Time frame: Baseline and 3 months
Measurement of depression widely used in clinical and research settings
1 secondary outcome
Generalized Anxiety Disorder- 7 item (GAD7)
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Long COVID
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Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Johnson, PhD, LCSW principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Intervention for Long COVID-19 (NICO) in people with Long COVID and Long Covid19, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Health Questionnarrie- 8 item (PHQ8) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.