Long COVID-19 Intervention Using Digital Health & Technology

Not Applicable

Not yet recruiting

• Conditions: Distress Tolerance; Long COVID
• Interventions: Behavioral: iENDURE

• Registration Number: NCT05616806
• Lead Sponsor: Rhode Island Hospital

Brief 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. 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-15
• Last Update Submitted: 2023-04-01
• Last Update Posted: 2023-04-04
• Study Start: 2023-07-01
• Primary Completion: 2024-07-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• Not fluent in English
• Limited mental capacity or inability to provide informed written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
distress tolerance skills training	iENDURE	technology delivered distress tolerance skills training

Primary Outcome Measures

Name	Time	Method
System Usability Score (SUS)	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.
Client Satisfaction Score (CSQ-8)	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.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States