Trials / Withdrawn
WithdrawnNCT06502444
Moving Forward Together 2.0: An Activity Intervention
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Rosalind Franklin University of Medicine and Science · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 (i.e., number of logins, video views, and discussion board posts) and satisfaction (i.e., 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Moving Forward Together Activity Intervention | The activity intervention program consists of videos and handouts to encourage participants to access these materials if they wish to increase their physical activity. The program lasts 8 weeks. Participants may access program materials for an additional four weeks after the program ends |
Timeline
- Start date
- 2024-08-01
- Primary completion
- 2024-11-15
- Completion
- 2024-11-20
- First posted
- 2024-07-16
- Last updated
- 2025-03-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06502444. Inclusion in this directory is not an endorsement.