Long COVIDLIGHTNCT05616806
Long COVID-19 Intervention Using Digital Health & Technology
A study testing iENDURE in people with Long COVID and Distress Tolerance, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Distress Tolerance
- What is being tested?
- iENDURE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jan 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be over 18 years of age
- Must speak English proficiently
- Must own a text-enabled device
- Diagnosis (self-reported) of COVID-19
- Diagnosis (self-reported) of Long-COVID symptom(s)
- Must be able to provide written, informed consent
Who cannot join
- Not fluent in English
- Limited mental capacity or inability to provide informed written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Project LIGHT - Long COVID-19 Intervention Using Digital Health & Technology
The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments
- Conditions
- Long COVID, Distress Tolerance
- Being tested
- iENDURE
- 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.
iENDUREBehavioural
Also called Marigold Health
Two delivery modes: computer and text message. The intervention provides introductory strategies for managing physical and emotional distress associated with Long COVID through a computer-delivered session followed by 4-weeks of theoretically-informed text messages intended to promote distress tolerance (DT).
Computer - the initial intervention will be delivered online via the Qualtrics survey tool following informed consent. The intervention provides strategies to better tolerate emotional and physical discomfort to persist with behavioral goals. Text Message - The text message intervention will be delivered using Marigold Health (a HIPAA compliant platform for secure text messaging). Participants will receive daily text messages that focus on emphasizing adaptive strategies for tolerating physical and emotional discomfort in order to work toward behavioral goals. The text messages will be personalized and offer skills training (reminders of previously learned DT skills).
| Study group | Role | What they receive |
|---|---|---|
| distress tolerance skills training | Experimental | technology delivered distress tolerance skills training Receives: Behavioral: iENDURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Score (CSQ-8)
Measure satisfaction scores after 4 weeks of using the intervention for this group of participants with Long COVID as measured by the client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: 4 weeks
System Usability Score (SUS)
Measure usability after 4 weeks for this group of participants with Long COVID as measured by the 10 item system usability scale. In the SUS instrument, even and odd questions are scored differently. Odd questions are scored 0-4 based on the 1-5 selection, where a selection of 1 equals 0 points, a selection of 2 equals 1 point, and so on. Even questions are scored 4-0 on the 1-5 selection where a selection of 1 equals 4 points, a selection of 2 equals 3 points, and so on. Scores for all ten questions are added up for a total score between 0-40 points. This total is multiplied by 2.5 to generate a SUS score between 0-100 points. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
- Investigators
- Kirsten Langdon, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616806
- Sponsor's protocol ID
- 2022003396
- Acronym
- LIGHT
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 4 Apr 2023
- Results posted
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project LIGHT - Long COVID-19 Intervention Using Digital Health & Technology
- ClinicalTrials.gov ID
- NCT05616806
- Acronym / sponsor ID
- LIGHT / 2022003396
- Conditions
- Long COVID, Distress Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 15 Nov 2022 (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.
The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| distress tolerance skills training | Experimental | Behavioral: iENDUREtechnology delivered distress tolerance skills training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be over 18 years of age
- Must speak English proficiently
- Must own a text-enabled device
- Diagnosis (self-reported) of COVID-19
- Diagnosis (self-reported) of Long-COVID symptom(s)
Key exclusion criteria (2 listed)
- Not fluent in English
- Limited mental capacity or inability to provide informed written consent
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 |
|---|---|---|
| iENDUREAlso: Marigold HealthTwo delivery modes: computer and text message. The intervention provides introductory strategies for managing physical and emotional distress associated with Long COVID through a computer-delivered session followed by 4-weeks of theoretically-informed text messages intended to promote distress tolerance (DT). Computer - the initial intervention will be delivered online via the Qualtrics survey tool following informed consent. The intervention provides strategies to better tolerate emotional and physical discomfort to persist with behavioral goals. Text Message - The text message intervention will be delivered using Marigold Health (a HIPAA compliant platform for secure text messaging). Participants will receive daily text messages that focus on emphasizing adaptive strategies for tolerating physical and emotional discomfort in order to work toward behavioral goals. The text messages will be personalized and offer skills training (reminders of previously learned DT skills). | Behavioural | distress tolerance skills training |
Primary outcome
Client Satisfaction Score (CSQ-8)
Time frame: 4 weeks
Measure satisfaction scores after 4 weeks of using the intervention for this group of participants with Long COVID as measured by the client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
System Usability Score (SUS)
Time frame: 4 weeks
Measure usability after 4 weeks for this group of participants with Long COVID as measured by the 10 item system usability scale. In the SUS instrument, even and odd questions are scored differently. Odd questions are scored 0-4 based on the 1-5 selection, where a selection of 1 equals 0 points, a selection of 2 equals 1 point, and so on. Even questions are scored 4-0 on the 1-5 selection where a selection of 1 equals 4 points, a selection of 2 equals 3 points, and so on. Scores for all ten questions are added up for a total score between 0-40 points. This total is multiplied by 2.5 to generate a SUS score between 0-100 points. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Kirsten Langdon, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iENDURE in people with Long COVID and Distress Tolerance, run by Rhode Island Hospital 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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?
Results are not available in the source record.
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?
Client Satisfaction Score (CSQ-8) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 4 Apr 2023.