Domestic ViolenceNCT04875494
Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims
A study testing Counseling/support group therapy and Physical Exercise in people with Domestic Violence, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial summary
The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Counseling/support group therapy and Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 5 Apr 2021
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having experienced domestic violence at some time in the past 2 months
Who cannot join
- not being physically active on a regular basis (less than 20 min of moderate-vigorous physical activity per day during the last year)
- absence of medical contraindication to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims
The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection
Read the detailed description
The present study design includes three arms (two intervention arms): Physical Exercise (Group A), Counseling/Support Group (Group B), and No Intervention (Control, Group C). Random allocation to each group was done in a 1:1:1 ratio at the end of an initial telephone interview by one of the authors. A permutated block design with a block size of three was used. For each participant in Groups A and B, the assigned intervention was started the week following the initial interview, and lasted 6 weeks.
- Conditions
- Domestic Violence
- Being tested
- Counseling/support group therapy, Physical Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling/support group therapyBehavioural
6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims
Physical ExerciseBehavioural
6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise | Experimental | Not described Receives: Behavioral: Physical Exercise |
| Counseling/support group therapy | Active comparator | Not described Receives: Behavioral: Counseling/support group therapy |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change score for each of the physical and global self esteem subscales from the Inventaire du Soi Physique (ISP-25). This instrument has 25 items each with a 6-point Likert response scale. Higher scores indicate greater self-esteem (physical or global)
magnitude of change in global and physical self-esteem from pre- to post-study. Minimum = -150; Maximum = +150
Measured: baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start24 Feb 2020
- Primary completion27 Feb 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabien Legrand, Université de Reims Champagne-Ardenne
- Investigators
- Stephanie CAILLIES, PhD, Study director, Université de Reims Champagne-Ardenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875494
- Sponsor's protocol ID
- DDCSPP
- Status last verified
- May 2021
- First submitted
- 21 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims
- ClinicalTrials.gov ID
- NCT04875494
- Acronym / sponsor ID
- DDCSPP
- Conditions
- Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 6 May 2021 (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 current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection
Detailed description
The present study design includes three arms (two intervention arms): Physical Exercise (Group A), Counseling/Support Group (Group B), and No Intervention (Control, Group C). Random allocation to each group was done in a 1:1:1 ratio at the end of an initial telephone interview by one of the authors. A permutated block design with a block size of three was used. For each participant in Groups A and B, the assigned intervention was started the week following the initial interview, and lasted 6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise | Experimental | Behavioral: Physical Exercise |
| Counseling/support group therapy | Active comparator | Behavioral: Counseling/support group therapy |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having experienced domestic violence at some time in the past 2 months
Key exclusion criteria (2 listed)
- not being physically active on a regular basis (less than 20 min of moderate-vigorous physical activity per day during the last year)
- absence of medical contraindication to exercise
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 |
|---|---|---|
| Counseling/support group therapy6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims | Behavioural | Counseling/support group therapy |
| Physical Exercise6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor | Behavioural | Physical Exercise |
Primary outcome
Change score for each of the physical and global self esteem subscales from the Inventaire du Soi Physique (ISP-25). This instrument has 25 items each with a 6-point Likert response scale. Higher scores indicate greater self-esteem (physical or global)
Time frame: baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline
magnitude of change in global and physical self-esteem from pre- to post-study. Minimum = -150; Maximum = +150
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
Related trials for Domestic Violence
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Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
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Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
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.
Stephanie CAILLIES, PhD study director
Université de Reims Champagne-Ardenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling/support group therapy and Physical Exercise in people with Domestic Violence, run by Université de Reims Champagne-Ardenne at 1 site in France.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change score for each of the physical and global self esteem subscales from the Inventaire du Soi Physique (ISP-25). This instrument has 25 items each with a 6-point Likert response scale. Higher scores indicate greater self-esteem (physical or global) (time frame: baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.