Long COVID-19 Intervention Using Digital Health & Technology

NCT ID: NCT05616806

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-01-01

Brief Summary

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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

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Conditions

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Long COVID Distress Tolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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distress tolerance skills training

technology delivered distress tolerance skills training

Group Type EXPERIMENTAL

iENDURE

Intervention Type BEHAVIORAL

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).

Interventions

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iENDURE

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Marigold Health

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsten Langdon, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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2022003396

Identifier Type: -

Identifier Source: org_study_id

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