跳至主要内容
临床试验/NCT06502444
NCT06502444撤回不适用

Moving Forward Together 2.0: An Activity Intervention

Rosalind Franklin University of Medicine and Science2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
120
试验地点
2
主要终点
Emotion Regulation Questionnaire (ERQ)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

There is only one condition. All participants know they are signing up for this one condition, an activity intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •18 years or older
  • •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

排除标准

  • •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

研究组 & 干预措施

Moving Forward Together Activity Intervention

Experimental

This is a single-arm project. All participants receive the same experimental intervention. The intervention is a gentle program encouraging greater participation in physical activity and healthy regulation of emotions.

干预措施: Moving Forward Together Activity Intervention (Behavioral)

结局指标

主要结局

Emotion Regulation Questionnaire (ERQ)

时间窗: This measure is completed at baseline, at the 4-week, and at the 8-week assessment.

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.

Physical activity progress.

时间窗: This measure is completed weekly for eight weeks

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.

Global Physical Activity Questionnaire

时间窗: This measure is completed at baseline and at the eight-week assessment

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.

Positive and Negative Affect Schedule (PANAS)

时间窗: This measure is completed at baseline and at the 8-week assessment

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.

Post-traumatic Stress Disorder Checklist-Civilian (PCL-C):

时间窗: This measure is completed at baseline and at the 4-week and 8-week assessment

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.

Program acceptability measure.

时间窗: This measure is only completed at the 8-week assessment.

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.

Affect Grid (Russell et al., 1989).

时间窗: This measure is completed weekly for eight weeks

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.

次要结局

  • Perceived Stress Scale (PSS)(This measure is completed at baseline, at the 4-week, and at the 8-week assessment.)
  • Online program use(Online program use is tracked separately for the eight-week program and for the four weeks following the end of the program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Kosson

Professor, retired

Rosalind Franklin University of Medicine and Science

研究点 (2)

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