Moving Forward Together 2.0: An Activity Intervention
NCT Number: NCT06502444
Acronym: MFT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Activity, Motor|Emotion Regulation
Interventions: BEHAVIORAL: Moving Forward Together Activity Intervention
Sponsor: Rosalind Franklin University of Medicine and Science
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-09-30
Locations: Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, 60064, United States|A Safe Place, Zion, Illinois, 60099, United States

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).

Primary Outcome Measures: Global Physical Activity Questionnaire, A 16-item measure of physical activity participation / sedentary behavior across three settings. We will assess whether participants engage in 150 minutes or more of leisure time physical activity per week. Those who do are ineligible for this study., This measure is completed at baseline and at the eight-week assessment|Post-traumatic Stress Disorder Checklist-Civilian (PCL-C):, The PCL-C is a 17-item validated measure used to assess the intensity and severity of symptoms of Post-Traumatic Stress Disorder (PTSD). Each of the items is scored 1 to 5, so scores range from 17 to 85; higher scores indicate more symptoms of PTSD., This measure is completed at baseline and at the 4-week and 8-week assessment|Positive and Negative Affect Schedule (PANAS), The PANAS is a 20-item method for assessing both positive and negative affect. The Positive and Negative Affect Scales contain ten items each. Items are scored 1 to 5, so total subscale scores range from 10 to 50, where higher scores indicate greater levels of positive or negative emotion., This measure is completed at baseline and at the 8-week assessment|Emotion Regulation Questionnaire (ERQ), The ERQ is a 10-item measure used to assess participants' habitual use of two emotion regulation strategies: cognitive reappraisal (5 items) and expressive suppression (5 items). Scores on each item range from 1 to 7, so the range of subscale scores is 5 to 35, where higher scores indicate greater reliance on reappraisal or suppression., This measure is completed at baseline, at the 4-week, and at the 8-week assessment.|Program acceptability measure., This 32-item measure assesses participants' experience of the online program. Participants also self-report their use of the different intervention components and the extent to which they found each component useful. There are 26 questions about participants' satisfaction with the program scored from 1 to 5. Scores will range from 1 to 150 where higher scores indicate greater satisfaction. There are also three questions about frequency of using different program features (scored from 0 to 6; range = 0 to 18; higher scores indicate greater frequency of using program elements. There is one question assessing the number of activity program units participants watched (ranging from 0 to 8, where a higher score indicates greater use of program material). There are 2 questions about participants' interest in continuing to access program materials. No scores will be computed from these questions., This measure is only completed at the 8-week assessment.|Physical activity progress., Participants will be asked to share their physical activity tracking for each of the eight weeks of the program by reporting on their daily minutes of physical activity using a provided worksheet., This measure is completed weekly for eight weeks|Affect Grid (Russell et al., 1989)., This single item measure assesses both activation and valence associated with emotional response. Participants will be asked to report their current emotional state on a 9 X 9 grid that provides information about the valence of their emotional state (from extremeley unpleasant to extremely pleasant) and the intensity (or arousal) of their emotional state (from extreme sleepiness to extreme arousal). Participants' grid choices can be scored as self-ratings of affective valence and intensity on a scale that ranges from 1 to 9 in each case. In short, valence and intensity scores will range from 1 to 9 each week, where higher scores indicate more positive feelings and more intense feelings, respectively., This measure is completed weekly for eight weeks
Secondary Outcome Measures: Perceived Stress Scale (PSS), The 10-item Perceived Stress Scale assesses the level of stress partcipants perceive in their lives. Each item is scored 0 to 4, so total scores can range from 0 to 40, where higher scores indicate reports of greater perceived stress., This measure is completed at baseline, at the 4-week, and at the 8-week assessment.|Online program use, Data from the online program will be extracted to track participants' use of the online program. Number of logins, number of video views, and number and content from discussion board posts will be extracted for each week of the online program, and during the 4 weeks the program website remains open after the 8-week program has ended, Online program use is tracked separately for the eight-week program and for the four weeks following the end of the program