Moving Forward Together 2.0: An Activity Intervention

NCT ID: NCT06502444

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-11-20

Brief Summary

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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

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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

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Activity, Motor Emotion Regulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Moving Forward Together Activity Intervention

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rosalind Franklin University of Medicine and Science

OTHER

Sponsor Role lead

Responsible Party

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David Kosson

Professor, retired

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Kosson, PhD

Role: PRINCIPAL_INVESTIGATOR

Rosalind Franklin University of Medicine and Science

Steven Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Rosalind Franklin University of Medicine and Science

Locations

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Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, United States

Site Status

A Safe Place

Zion, Illinois, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12916575 (View on PubMed)

Watson 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.

Reference Type BACKGROUND
PMID: 3397865 (View on PubMed)

Bull 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.

Reference Type BACKGROUND
PMID: 20101923 (View on PubMed)

Neumann 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.

Reference Type BACKGROUND
PMID: 22984856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24188155 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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CHP23-428

Identifier Type: -

Identifier Source: org_study_id

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