Clinical trial NCT06502444: Moving Forward Together 2.0: An Activity Intervention
Official title: Moving Forward Together 2.0: An Activity Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Activity, Motor
Emotion Regulation
Keywords: activity
activity intervention
Post-traumatic Stress Disorder
intimate partner violence
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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.
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Female
* Reporting a previous relationship with an individual that included abuse or trauma
* Capable of reading and understanding English
* Not currently living with the individua
* Currently involved with A Safe Place in Zion, IL

Exclusion Criteria:

* Women without reliable internet access
* Individuals already meeting physical activity guidelines (150 minutes of physical activity or more per week)
* Women who report health problems that make activity unsafe or for whom healthcare professionals believe activity might be unsafe

Primary outcomes:
measure: Global Physical Activity Questionnaire
timeFrame: This measure is completed at baseline and at the eight-week assessment
measure: Post-traumatic Stress Disorder Checklist-Civilian (PCL-C):
timeFrame: This measure is completed at baseline and at the 4-week and 8-week assessment
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: This measure is completed at baseline and at the 8-week assessment
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: This measure is completed at baseline, at the 4-week, and at the 8-week assessment.
measure: Program acceptability measure.
timeFrame: This measure is only completed at the 8-week assessment.
measure: Physical activity progress.
timeFrame: This measure is completed weekly for eight weeks
measure: Affect Grid (Russell et al., 1989).
timeFrame: This measure is completed weekly for eight weeks
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: This measure is completed at baseline, at the 4-week, and at the 8-week assessment.
measure: Online program use
timeFrame: Online program use is tracked separately for the eight-week program and for the four weeks following the end of the program
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Rosalind Franklin University of Medicine and Science
state: Illinois
city: Zion
country: United States
facility: A Safe Place
state: Illinois
Study officials:
affiliation: Rosalind Franklin University of Medicine and Science
name: David Kosson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rosalind Franklin University of Medicine and Science
name: Steven Miller, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Karstoft KI, Andersen SB, Bertelsen M, Madsen T. Diagnostic accuracy of the posttraumatic stress disorder checklist-civilian version in a representative military sample. Psychol Assess. 2014 Mar;26(1):321-5. doi: 10.1037/a0034889. Epub 2013 Nov 4.
citation: Russell JA, Weiss A, Mendelsohn, GA. Affect grid: A single item scale of pleasure and activation. J Pers Soc Psychol. 1989; 57, 493-502. http://dx.doi.org/10.1037/0022-3514.57.3.493