Activity, MotorMFTNCT06502444
Moving Forward Together 2.0: An Activity Intervention
A study testing Moving Forward Together Activity Intervention in people with Activity, Motor and Emotion Regulation, run by Rosalind Franklin University of Medicine and Science at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Activity, Motor, Emotion Regulation
- What is being tested?
- Moving Forward Together Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, 60064
A Safe Place
Zion, Illinois, 60099
About this study
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).
Read the 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
- Activity, Motor, Emotion Regulation
- Being tested
- Moving Forward Together Activity Intervention
- Keywords
- activity, activity intervention, Post-traumatic Stress Disorder, intimate partner violence
- Medical subject headings
- Motor Activity, Emotional Regulation, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving Forward Together Activity InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Moving Forward Together Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This measure is completed weekly for eight weeks
Secondary outcomes (2)
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.
Measured: 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
Measured: Online program use is tracked separately for the eight-week program and for the four weeks following the end of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024
- Primary completion15 Nov 2024
- Study completion20 Nov 2024
Why it stopped: An insufficient number of prospective volunteers provided informed consent to provide a fair test of whether the intervention would be effective. More people were needed to make shared online feedback and support a useful component.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kosson, Rosalind Franklin University of Medicine and Science
- Investigators
- David Kosson, PhD, Principal investigator, Rosalind Franklin University of Medicine and ScienceSteven Miller, PhD, Principal investigator, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502444
- Sponsor's protocol ID
- CHP23-428
- Acronym
- MFT
- Status last verified
- Feb 2025
- First submitted
- 14 Jun 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected in this study will not be shared with researchers outside of the identified research personnel.
Publications
Cohen S, Williamson, G. Perceived stress in a probability sample of the United States. In: Spacapan, S, Oskamp, S, ed. The social psychology of health: Claremont symposium on applied social psychology. Newbury Park, CA: Sage; 1988:31-57. www.cmu.edu/dietrich/psychology/stress-immunity-disease-lab/scales/pdf/cohen,-s.--williamson,-g.-1988.pdf
Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
PubMed 12916575Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity study. J Phys Act Health. 2009 Nov;6(6):790-804. doi: 10.1123/jpah.6.6.790.
PubMed 20101923Neumann CS, Pardini D. Factor structure and construct validity of the Self-Report Psychopathy (SRP) scale and the Youth Psychopathic Traits Inventory (YPI) in young men. J Pers Disord. 2014 Jun;28(3):419-33. doi: 10.1521/pedi_2012_26_063. Epub 2012 Sep 17.
PubMed 22984856Karstoft 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.
PubMed 24188155Russell 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving Forward Together 2.0: An Activity Intervention
- ClinicalTrials.gov ID
- NCT06502444
- Acronym / sponsor ID
- MFT / CHP23-428
- Conditions
- Activity, Motor, Emotion Regulation
- Keywords
- activity, activity intervention, Post-traumatic Stress Disorder, intimate partner violence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: An insufficient number of prospective volunteers provided informed consent to provide a fair test of whether the intervention would be effective. More people were needed to make shared online feedback and support a useful component.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moving Forward Together Activity Intervention | Experimental | Behavioral: Moving Forward Together Activity InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moving Forward Together Activity InterventionThe 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 | Behavioural | Moving Forward Together Activity Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- BackgroundCohen S, Williamson, G. Perceived stress in a probability sample of the United States. In: Spacapan, S, Oskamp, S, ed. The social psychology of health: Claremont symposium on applied social psychology. Newbury Park, CA: Sage; 1988:31-57. www.cmu.edu/dietrich/psychology/stress-immunity-disease-lab/scales/pdf/cohen,-s.--williamson,-g.-1988.pdf
- Background: PubMed 12916575Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 20101923Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity study. J Phys Act Health. 2009 Nov;6(6):790-804. doi: 10.1123/jpah.6.6.790.
- Background: PubMed 22984856Neumann CS, Pardini D. Factor structure and construct validity of the Self-Report Psychopathy (SRP) scale and the Youth Psychopathic Traits Inventory (YPI) in young men. J Pers Disord. 2014 Jun;28(3):419-33. doi: 10.1521/pedi_2012_26_063. Epub 2012 Sep 17.
- Background: PubMed 24188155Karstoft 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.
- BackgroundRussell 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
- Individual participant dataSharing planned: No. Data collected in this study will not be shared with researchers outside of the identified research personnel.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kosson, PhD principal investigator
Rosalind Franklin University of Medicine and Science
Steven Miller, PhD principal investigator
Rosalind Franklin University of Medicine and Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving Forward Together Activity Intervention in people with Activity, Motor and Emotion Regulation, run by Rosalind Franklin University of Medicine and Science at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Physical Activity Questionnaire (time frame: This measure is completed at baseline and at the eight-week assessment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502444, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.