Moving Forward Together 2.0: An Activity Intervention (MFT)

February 26, 2025 updated by: David Kosson, Rosalind Franklin University of Medicine and Science
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • North Chicago, Illinois, United States, 60064
        • Rosalind Franklin University of Medicine and Science
      • Zion, Illinois, United States, 60099
        • A Safe Place

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moving Forward Together Activity Intervention
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global Physical Activity Questionnaire
Time Frame: 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.
This measure is completed at baseline and at the eight-week assessment
Post-traumatic Stress Disorder Checklist-Civilian (PCL-C):
Time Frame: 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.
This measure is completed at baseline and at the 4-week and 8-week assessment
Positive and Negative Affect Schedule (PANAS)
Time Frame: 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.
This measure is completed at baseline and at the 8-week assessment
Emotion Regulation Questionnaire (ERQ)
Time Frame: 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.
This measure is completed at baseline, at the 4-week, and at the 8-week assessment.
Program acceptability measure.
Time Frame: 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.
This measure is only completed at the 8-week assessment.
Physical activity progress.
Time Frame: 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.
This measure is completed weekly for eight weeks
Affect Grid (Russell et al., 1989).
Time Frame: 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.
This measure is completed weekly for eight weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS)
Time Frame: This measure is completed at baseline, at the 4-week, and at the 8-week assessment.
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
Time Frame: Online program use is tracked separately for the eight-week program and for the four weeks following the end of the program
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rosalind Franklin University of Medicine and Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Kosson, PhD, Rosalind Franklin University of Medicine and Science
  • Principal Investigator: Steven Miller, PhD, Rosalind Franklin University of Medicine and Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHP23-428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected in this study will not be shared with researchers outside of the identified research personnel.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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