Viewing Study NCT06502444



Ignite Creation Date: 2024-10-26 @ 3:34 PM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06502444
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-06-14

Brief Title: Moving Forward Together 20 An Activity Intervention
Sponsor: None
Organization: None

Study Overview

Official Title: Moving Forward Together 20 An Activity Intervention
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
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: MFT
Brief Summary: The study will test whether an online physical activity program that includes mindfulness can increase activity in women who have been abused by a relationship partner The study also aims to test whether this intervention can improve their ability to control their emotions and use mindfulness and reduce their stress and Post-Traumatic Stress Disorder PTSD symptoms The intervention is on the internet and provides participants with informational videos as well as support and encouragement from other program participants The intervention aims to encourage participants to choose their own physical activities and also includes components designed to foster healthy regulation of emotion addressing negative thoughts and feelings that may get in the way of exercise recognizing accomplishments and rewarding oneself etc This activity intervention is designed to take eight weeks Participants are tested initially at baseline halfway through the program Week 4 and at the end of the program Week 8
Detailed Description: The proposed design is a single condition longitudinal pilot study examining the feasibility of using an online physical activity program to increase physical activity and improve emotion regulation in women who have experienced trauma due to experiencing an abusive or harmful relationship All participants receive the same intervention The study will be conducted on the online Wix Classroom platform which is a secure online platform to which only participants and research staff will have access Women who have varying levels of trauma as determined by the PTSD Checklist-Civilian PCL-C will be invited to participate in the study via A Safe Place an organization to help survivors of intimate partner violence Participants will complete the online program and are asked to complete assessments at baseline 4 weeks and 8 weeks Though they will not be required to access the program their continued use of the program after the end of the 8-week program will be examined for 4 additional weeks The primary aim of this study is to assess the feasibility of the intervention Descriptive statistics will be conducted to assess participant engagement ie number of logins video views and discussion board posts and satisfaction ie program acceptability questionnaire responses Feasibility data will help discern what program components participants found most useful Longitudinal models will be used to examine the effect of program participation on physical activity mood and emotion regulation stress levels and PTSD symptoms over time

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