Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631729
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders A mHEALTH Interoceptive Exposure Intervention the Bio-HEALTH Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders A mHEALTH Interoceptive Exposure Intervention the Bio-HEALTH Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will be fully remote virtual and include observational design features assessments plus a clinical trial All assessments will be completed using HIPAA-approved platforms eg Qualtrics MindLogger EMA platform After screening via Qualtrics to determine eligibility described below participants will complete a cross-sectional survey via Qualtrics followed by a baseline EMA period During the baseline EMA period participants will receive brief 3-5 minutes surveys on their mobile devices 6 times per day for 7-days via the MindLogger app During the baseline EMA period participants will also be asked to wear non-invasive chest-worn Holter monitors Polar H10 Holter monitors that will capture their heartrate variability data
They will then complete the 4-week intervention HRV bio or ED-JITAI treatment arms see below followed by a post-intervention 7-day EMA assessment period while they also wear the Holter monitors Recruitment is expected to last for 15 years In HRV-bio participants will also complete a HRV biofeedback task via the Elite HRV app In this intervention participants will learn how to use their HRV data that they will see in real-time via the Elite HRV app to improve their HRV by engaging in an app-guided diaphragmatic breathing exercise They will complete this exercise twice daily morning night In ED-JITAI participants will be prompted to complete focused guided body scan tasks that will be sent to them via the MindLogger app These guided tasks will be sent to them in the form of 1 of 3 brief 3-5 minute videos via the MindLogger app The body scans will be designed to promote participants connection with vs
distancingdistraction from feared ED sensations eg hunger satiety bloating
Participants will receive prompts to complete the body scans at times when they report via EMA that they are experiencing worse interoception than usual Worse interoception than usual will be defined as participants EMA-reported interoception scores during the intervention period that fall 1 SD or more above their baseline EMA-reported interoception levels
They will then complete the 4-week intervention HRV bio or ED-JITAI treatment arms see below followed by a post-intervention 7-day EMA assessment period while they also wear the Holter monitors Recruitment is expected to last for 15 years In HRV-bio participants will also complete a HRV biofeedback task via the Elite HRV app In this intervention participants will learn how to use their HRV data that they will see in real-time via the Elite HRV app to improve their HRV by engaging in an app-guided diaphragmatic breathing exercise They will complete this exercise twice daily morning night In ED-JITAI participants will be prompted to complete focused guided body scan tasks that will be sent to them via the MindLogger app These guided tasks will be sent to them in the form of 1 of 3 brief 3-5 minute videos via the MindLogger app The body scans will be designed to promote participants connection with vs
distancingdistraction from feared ED sensations eg hunger satiety bloating
Participants will receive prompts to complete the body scans at times when they report via EMA that they are experiencing worse interoception than usual Worse interoception than usual will be defined as participants EMA-reported interoception scores during the intervention period that fall 1 SD or more above their baseline EMA-reported interoception levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None